[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphoblastic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphoblastic-leukemia":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,141,0,25,[9,46,71,99,119,141,178,204,230,251,271,305,334,353,383,461,484,515,535,555,587,629,656,687,717],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100636934","anti-crlf2-rtslpr-chimeric-antigen-receptor-t-cells-tslpr-cart-in-participants-with-recurrent-or-refractory-crlf2-rtslpr-overexpressing-b-cell-acute-lymphoblastic-leukemia-b-all-100636934",false,"NCT07572136","Anti-CRLF2-R\u002FTSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R\u002FTSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)","Phase I Dose Escalation Study of Anti-CRLF2-R\u002FTSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R\u002FTSLPR-Overexpressing B-cell Acute Lymphoblastic Leukemia (B-ALL)","* INCLUSION CRITERIA:\n\n  1. Documentation of pathologic confirmation of a diagnosis of B-Cell acute lymphoblastic leukemia (ALL).\n  2. TSLPR+ expression must be detected on \\>=80% of the malignant cells by NSR device. Note: TSLPR+ expression does not need to be repeated by NSR device if there is a documentation of TSLPR surface expression by flow cytometry from a Clinical Laboratory Improvement Amendments (CLIA) approved laboratory.\n  3. Participants must have a disease that is relapsed or refractory after initial systemic therapy and at least one salvage treatment, and must either be ineligible for, cannot access in a timely manner, or declined alternative curative options (including commercial CAR Tcell constructs\\*, and\u002For have relapsed after allogeneic HSCT).\n\n     \\*Individuals that are CD19 positive will be considered for this study, However, these individuals should be ineligible for, unable to obtain in a timely manner, cannot access, unwilling to undergo, or have failed prior FDA approved CD19 CAR constructs.\n  4. Participants must have measurable or evaluable disease at the screening, defined by any evidence of MRD or positron emission tomography (PET)-avid extramedullary disease\n  5. Age \\>= 18 years\n  6. Clinical performance status: Karnofsky \\>= 50%. Participants who are unable to walk because of paralysis, but who are upright in a wheelchair will be considered ambulatory for the purpose of calculating the performance score.\n  7. Participants must have adequate organ and marrow function as defined below:\n\n     * Leukocytes \\>= 750\u002FmcL\\*\n     * Platelets \\>= 50,000\u002FmcL\\*\n     * Total bilirubin \\\u003C= 2 x upper limit of normal (ULN) (except in the case of participants with documented Gilbert s disease \\> 3 X ULN)\n     * Aspartate Aminotransferase (AST)\u002FAlanine Aminotransferase (ALT) \\\u003C= 5 X institutional ULN\n     * Creatinine \\\u003C 1.5X ULN OR Creatinine clearance \\>= 60 mL\u002Fmin\u002F1.73m\\^2 for participants with creatinine levels above max listed above\n\n       * A participant will not be excluded because of pancytopenia \\>=Grade 3 if it is due to underlying bone marrow involvement by leukemia\n  8. Cardiac function: left ventricular ejection fraction (LVEF) \\>=45% or fractional shortening \\>= 28%, and no clinically significant electrocardiogram (EKG) findings\n  9. Pulmonary Function: Baseline oxygen saturation \\> 92% on room air at rest without oxygen supplementation\n  10. Participants with the following central nervous system (CNS) status are eligible:\n\n      * CNS 1, defined as absence of blasts in CSF on cytospin preparation, regardless of the number of WBCs;\n      * CNS 2, defined as presence of \\\u003C 5\u002FmcL WBCs in CSF and cytospin positive for blasts, or \\> 5\u002FmcL WBCs but negative by Steinherz\u002FBleyer algorithm:\n\n        * CNS 2a: \\\u003C 10\u002FmcL red blood cells (RBCs); \\\u003C 5\u002FmcL WBCs and cytospin positive for blasts;\n        * CNS 2b: \\>=10\u002FmcL RBCs; \\\u003C 5\u002FmcL WBCs and cytospin positive for blasts;\n        * CNS 2c: \\>=10\u002FmcL RBCs; \\>= 5\u002FmcL WBCs and cytospin positive for blasts but negative by Steinherz\u002FBleyer algorithm.\n  11. Contraception:\n\n      * Women of child-bearing potential (WOCBP) must agree to use a highly effective contraception (hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) at the study entry and up to 12 months after the last dose of combined chemotherapy. Note: WOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n      * Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and for 4 months after the last dose of study drugs. We also will recommend men ask their partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Men able to father a child must not freeze or donate sperm within the same period.\n  12. Nursing participants must be willing to discontinue nursing from study treatment initiation through 1 month after the last dose of the study drug(s).\n  13. Ability and willingness of participant or Legally Authorized Representative (LAR) to co-enroll on 15-C-0028: Follow-up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials.\n  14. Participant or LAR must understand and sign a written informed consent.\n\n      EXCLUSION CRITERIA:\n\n  \u003C!-- -->\n\n  1. Recurrent or refractory leukemia limited to isolated testicular or isolated CNS disease\n  2. CNS 3 disease including participants with radiologically detected active CNS lymphoma, or participants who have cranial nerve palsy from active CNS leukemia. Note: Chronic complications of prior CNS disease are not exclusionary in the absence of active disease (e.g., blindness from prior ocular CNS disease or persistent cranial nerve palsy)\n  3. Hyperleukocytosis (\\>=50,000 blasts\u002FmcL)\n  4. Positive serum or urine beta-human chorionic gonadotropin (beta-HCG) pregnancy test performed in WOCBP at screening.\n  5. Washout criteria (time prior to apheresis or prior to start of LD if apheresis is not done on this protocol):\n\n     ====\n\n     Therapy: Systemic chemotherapy, antineoplastic investigational agents, or antibody-based therapies, any investigational therapy\n\n     Washout\\*: \\>= 2 weeks\n\n     Exceptions: 6 weeks for clofarabine or nitrosoureas No washout for prior intrathecal chemotherapy, steroid therapy, hydroxyurea (no dose increases within prior 2 weeks) or ALL maintenance type chemotherapy (vincristine, 6- mercaptopurine, oral methotrexate, or a tyrosine kinase for participants with Ph+ or Ph-like ALL) provided there is recovery from any acute toxic effects.\n\n     ====\n\n     Therapy: Radiation therapy\n\n     Washout\\*: \\>= 3 weeks\n\n     Exceptions: No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the participant has measurable\u002Fevaluable disease outside the radiation window.\n\n     ====\n\n     Therapy: History of allogeneic HSCT\n\n     Washout\\*: \\>=100 days since HSCT; \\>=30 days since completion of immunosuppression; \\>=6 weeks since donor lymphocyte infusion (DLI)\n\n     ====\n\n     Therapy: History of prior CAR therapy or other adoptive cell therapies\n\n     Washout\\*: \\> 30 days post infusion\n     * Time between prior therapy and apheresis or prior to start of LD if apheresis is not done on this protocol.\n  6. Human immunodeficiency virus (HIV) infection, as measured by seropositivity for HIV antibody.\n  7. Hepatitis B virus (HBV) infection, as measured by positivity for hepatitis B surface antigen (HbsAg).\n  8. Hepatitis C virus (HCV) infection, as measured by seropositivity for hepatitis C.\n  9. Active second malignancy with the exception of in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and participant is in remission.\n  10. History of severe, immediate hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells.\n  11. Evidence of active graft-versus- host disease (GVHD).\n  12. Uncontrolled, symptomatic, intercurrent illness or social situations as evaluated by medical history, physical exam, and laboratory evaluations that would limit compliance with study requirements or would pose an unacceptable risk to the participant.","ALL","18 Years","120 Years",{"count":21,"type":22},57,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Background:\n\nB-cell acute lymphoblastic leukemia (B-ALL) is a type of blood cancer. Some people with B-ALL have a gene mutation that makes the disease hard to treat. The mutation causes cancer cells to make too much of a protein called thymic stromal lymphopoietin receptor (TSLPR). Chimeric antigen receptor (CAR) T cell therapy is a treatment that takes immune cells (T cells) from a person s body and modifies them to attack specific proteins. Researchers want to test whether TSLPR-CART cells can be given safely to adults with forms of B-cell leukemia, and to learn whether the treatment may help fight these cancers.\n\nObjective:\n\nTo test TSLPR-CART in people with B-ALL.\n\nEligibility:\n\nPeople aged 18 years and older with B-ALL that did not respond or returned after treatment. They must have TSLPR on their B-ALL.\n\nDesign:\n\nParticipants will be screened. They will have imaging scans and tests of their heart function. Samples will be taken from their bone marrow. They will have a lumbar puncture: A needle will be inserted into their back to collect a sample of the fluid around the spinal cord.\n\nParticipants will undergo leukapheresis: Blood will be taken from their body through a tube. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different tube. The T cells will be used to create TSLPR-CART.\n\nParticipants will take chemotherapy over 5 days to prepare their body for the therapy; then they will receive the modified cells through a tube inserted into a vein. Staying in the hospital during part of the treatment is expected and participants will be monitored locally to evaluate for side effects. Approximately 1 month after receiving TSLPR-CART, participants will undergo evaluations to see how the TSLPR-CART impacted their leukemia. Participants will have follow-up visits for 2 years after TSLPR-CART either at NIH or at home....",[28,29],"B-All","Acute Lymphoblastic Leukemia",[31,32,29,28],"Adoptive Immunotherapy","CRLF2-R\u002FTSLPR Expressing Tumor","NOT_YET_RECRUITING","2026-08-20",{"date":36,"type":37},"2026-08-21","ACTUAL",{"date":39,"type":22},"2026-08-26",{"date":41,"type":22},"2032-06-30",{"name":43,"class":44},"National Cancer Institute (NCI)","NIH",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100486993","a-multicenter-study-to-evaluate-next-generation-sequencing-ngs-testing-and-monitoring-of-b-cell-recovery-to-guide-management-following-chimeric-antigen-receptor-t-cell-cart-induced-remission-in-children-and-young-adults-with-b-lineage-acute-lymph-100486993","NCT05621291","A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...","A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymphoblastic Leukemia","* INCLUSION CRITERIA:\n* Age \\>=1 year and \\\u003C= 25 years old at the time of CD19 CART infusion\n* Confirmed diagnosis of CD19+ B-ALL with an informative NGS clonality sample\n\n  --Have an informative NGS clonality sample for MRD assessment based on immunoglobulin rearrangement in bone marrow or blood at any time of active disease between diagnosis and CD19 CART infusion and any time prior to the first on-study intervention confirmed by NGS MRD testing.\n* Post-CD19 CART infusion disease status:\n\n  * Are in bone marrow morphologic complete remission and are flow cytometry measurable residual disease (MRD) negative within 42 days post CD19 CART infusion.\n  * Are NGS MRD negative by tracking sample in the bone marrow within 42 days post CD19 CART infusion confirmed by NGS MRD testing.\n* Received first CD19 (4-1BB) CART within 42 days prior to enrollment. Note: Eligible CART including FDA approved Kymriah (tisagenlecleucel) infused on a treatment plan, research study, or other comparable 4-1BB based constructs.\n\nStudy chairs will determine whether other 4-1BB CART are considered comparable.\n\n* All participants must have an allogeneic HCT donor identified for potential HCT. Note: Donor identification and selection will be according to institutional practice.\n* Have B-cell aplasia (BCA) post CD19 CART persisting within 42 days post CD19 CART infusion. Note: BCA persisting is defined as \\\u003C1% B cells lymphocytes or \\\u003C50 B cells\u002Fmicroliter in the peripheral blood\n* Performance of all screening tests prior to day 42 post CD19 CART.\n* The ability of participant or parent\u002Fguardian to understand and the willingness to sign a written consent document or participants unable to consent if they are represented by a Legally Authorized Representative (LAR).\n\nEXCLUSION CRITERIA:\n\n* Prior hematopoietic stem cell transplantation (HCT)\n* Recent history of the extramedullary disease (EMD) that requires ongoing radiographic surveillance (e.g., participants with active EMD at CD19 CART infusion that requires monitoring by imaging without the ability to more precisely assess disease status will be ineligible). A remote history of EMD does not exclude the participant.\n* Active and\u002For residual central nervous system (CNS) disease that requires ongoing therapy or monitoring.\n* Co-morbidities precluding myeloablative HCT. Note: Determination of co-morbidities precluding myeloablative HCT will be made by the treating transplant (HCT) physician and documented in the research record. This does not require that the participant is immediately fully eligible for HCT, only that there are no long-term comorbidities that would preclude a myeloablative approach (e.g., renal failure, severe cardiac failure, long-term oxygen requirement).\n* Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements. Note: Determination of uncontrolled, symptomatic illness or social situation that would limit compliance with the study requirements will be made by the site-PI and documented in the research record.","1 Year","25 Years",{"count":56,"type":22},60,[58],"NA","Background:\n\nChimeric antigen receptor T-cell (CART) therapy is a form of immunotherapy which can be used to treat people with relapsed B-ALL. For those who achieve remission after CART alone, it may cure up to 50% of people who receive this therapy. However, for people who relapse after CART, it can be hard to achieve remission again. In patients where CART fails, stem cell transplant (HCT) can be used to prevent relapse and achieve cure. But HCT can cause serious side effects. Better testing is needed to distinguish people who can be cured with CART alone from people who may also need to have HCT.\n\nObjective:\n\nTo see if the use of a series of blood and bone marrow tests at regular intervals can help monitor for B-ALL relapse after CART therapy.\n\nEligibility:\n\nPeople aged 1 to 25 years with B-ALL who have had CART therapy within the past 42 days. They must never have had a blood stem cell transplant; they must also have no measurable blood cancer cells.\n\nDesign:\n\nParticipants will visit the clinic every 2 weeks starting 42 days after they receive CART therapy. Each visit will be about the same amount of time as a regular clinic visit. about 8 hours.\n\nParticipants will have blood drawn for testing on each visit.\n\nBone marrow biopsy\u002Faspirate will be done during 4 of the visits at routine timepoints after CART. A needle will be inserted to draw a sample of tissue from inside the bone in the hip.\n\nA small amount of blood and tissue will be tested with ClonoSEQ and to evaluate for normal B-cells side by side with the standard tests.\n\nThe combined testing may help determine whether participants are eligible for HCT and\u002For at risk of relapse after CART.\n\nParticipants will be in the study for 2 years.",[28,29],[28,62,63],"Car-Cure","Result Monitoring","RECRUITING",{"date":36,"type":37},{"date":39,"type":22},{"date":68,"type":22},"2027-12-31",{"name":43,"class":44},8,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100623699","phase-2-a-study-of-obecabtagene-autoleucel-in-people-with-b-cell-acute-lymphoblastic-leukemia-100623699","NCT07400029","A Study of Obecabtagene Autoleucel in People With B-cell Acute Lymphoblastic Leukemia","A Phase II Trial of Obecabtagene Autoleucel Consolidation in Adult Patients With Acute Lymphoblastic Leukemia in First Complete Remission Without Measurable Residual Disease","Inclusion Criteria:\n\n* Diagnosis of CD19+ B-cell ALL.\n\n  * Both Ph-negative and Ph-positive are allowed\n  * Patients with EMD must have detectable disease in the bone marrow (by flow cytometry or molecular methods) in order to follow MRD.\n* Patients aged ≥ 40 years at time of screening A.\n* Patients aged 30-39 years (at time of Screening A) are allowed in the presence of high-risk comorbidities or poor tolerability of chemotherapy (e.g. history or experienced pancreatitis with therapy, BMI ≥40kg\u002Fm2, underlying liver disease precluding safer administration of pediatric inspired regimens, any further combination of documented severe comorbidities that the investigator judges to be incompatible with administering an intensive pediatric or pediatric-inspired standard chemotherapy regimen).\n* In MRD negative CR or CR with incomplete hematologic recovery (CRi) at the time of screening. MRD will be assessed by flow cytometry and\u002For molecular testing such as ClonoSEQ at the minimum sensitivity of 10-4 from the bone marrow. Patients with MRD \\\u003C10\\^-4 will be eligible.\n* Patients may receive more than one course of upfront induction and\u002For consolidation, but must be in MRD- CR\u002FCRi at time of screening, within 4 months from initiation of treatment. The 4-month window will be measured from the first day of anti-leukemic therapy initiation (excluding steroid prophase) until the Screening A test for the trial.\n\nFrontline regimens include but are not limited to:\n\n* HyperCVAD or mini-hyper-CVD\n* Asparaginase-containing multiagent chemotherapy (e.g. CALGB10403, pediatric inspired chemo)\n* Inotuzumab or blinatumomab with or without chemotherapy\n* Tyrosine kinase inhibitor plus steroids, chemotherapy, or blinatumomab\n\n  \\- Adequate organ function at time of screening A, including:\n* ALT or AST ≤5x ULN and total bilirubin ≤2 (or ≤3 if history of Gilbert's syndrome or leukemic infiltration of the liver)\n* Serum creatinine \\\u003C2.0mg\u002FdL\n* SaO2 ≥92% on room air\n* Left ventricular ejection fraction (LVEF) ≥50% within 1 month of screening\n\n  * ECOG performance status 0-2\n  * CD19 expression is required at any time since diagnosis. CD19 expression may be detected by immunohistochemistry or by flow cytometry. Patients receiving prior blinatumomab are eligible if there is no documentation of CD19-negative disease after blinatumomab.\n  * CNS1 status must be documented at time of screening by CSF assessment. Patients with prior CNS2 or CNS3 disease must be CNS1 at screening and have no residual CNS deficits or symptoms.\n  * Patients will need to adhere to institutional contraception guidelines for a minimum of 1 year.\n  * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n\nExclusion Criteria:\n\n* Burkitt's leukemia or lymphoma\n* Patients with measurable extramedullary disease at screening are excluded. Patients with prior history of extramedullary disease are allowed after documentation of disease resolution by either PET\u002FCT scan (or CT with contrast if PET cannot be performed).\n* The following medications are excluded:\n\n  * Steroids: Therapeutic doses of corticosteroids (greater than 10mg daily of prednisone or its equivalent) within 7 days of leukapheresis or 72 hours prior to CAR T cell infusion.\n  * Systemic chemotherapy: Must be discontinued 7 days prior to leukapheresis or 7 days prior to starting lymphodepleting chemotherapy if used during bridging.\n  * Tyrosine kinase inhibitors: Must be discontinued 48 hours prior to apheresis and 48 hours prior to starting lymphodepleting chemotherapy, if used during bridging.\n  * Blinatumomab must be discontinued 5 days before apheresis\n  * Inotuzumab must be discontinued 2 weeks before apheresis to allow T cell recovery\n* Patients with uncontrolled systemic fungal, bacterial, viral or other infection at time of leukapheresis or at time of CAR T cell infusion\n* Blinatumomab may not be used as bridging therapy following apheresis\n* Positive test indicating the presence of active infection with the following pathogens: HIV, Hepatitis B (detectable Hep B DNA by PCR or Hep B surface antigen), Hepatitis C (detectable Hep C RNA by PCR), HTLV, Syphilis. The tests required will be agreed upon with the manufacturer to comply with manufacturer's regulatory and manufacturing requirements.","40 Years",{"count":80,"type":22},40,[82],"PHASE2","The researchers are doing this study to find out whether obecabtagene autoleucel (obe-cel) is an effective treatment for people with B-cell acute lymphoblastic leukemia (ALL) that is in complete remission (CR, meaning all signs of cancer are gone) with no measurable residual disease (MRD-negative, meaning there are no detectable cancer cells). Participants in this study will have received past treatment for their B-cell ALL, and their disease will be in MRD-negative CR for the first time (first MRD-negative CR).",[29],[86,87,88],"Obecabtagene Autoleucel","B-cell","25-342","2026-08-19",{"date":34,"type":37},{"date":92,"type":37},"2026-02-03",{"date":94,"type":22},"2029-02",{"name":96,"class":97},"Memorial Sloan Kettering Cancer Center","OTHER",9,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":45},"100533531","phase-1-pilot-study-of-anti-cd19-chimeric-antigen-receptor-t-cells-car-t-cells-for-the-treatment-of-relapsedrefractory-cd19-malignancies-100533531","NCT06227026","Pilot Study of Anti-CD19 Chimeric Antigen Receptor T Cells (CAR-T Cells) for the Treatment of Relapsed\u002FRefractory CD19+ Malignancies","PRODIGY","Inclusion Criteria:\n\n* Subjects aged ≥ 18 years.\n* Histologically confirmed relapsed or refractory CD-19+ malignancy, including: non-Hodgkin lymphoma (NHL), acute lymphoblastic leukemia (ALL), Chronic Lymphocytic Leukemia (CLL)\u002FRichter's syndrome. CD-19+ must be confirmed by immunohistochemistry or flow cytometry analysis.\n* Subjects who have relapsed or refractory disease after failing at least 2 or more prior lines of therapy.\n* ECOG Performance Status ≤ 2.\n* Life expectancy \\> 12 weeks.\n* Willing to consent to 15 years of follow-up as part of IRB 110692: Long-Term Evaluation of the Biology and Outcomes of Hematopoietic Stem Cell Transplantation\n* Adequate organ function as defined as:\n\n  * Hematologic:\n\n    * Absolute neutrophil count (ANC) ≥ 500\u002Fmm3\n    * Platelet count ≥ 10,000\u002Fmm3\n    * Hemoglobin ≥ 8 g\u002FdL\n  * Hepatic:\n\n    * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN).\n    * AST(SGOT)\u002FALT(SGPT) ≤ 3 × institutional ULN\n  * Renal:\n\n    * Serum Creatinine ≤ 2 x institutional upper limit of normal (ULN) or eGFR \\>30 ml\u002Fmin\u002F1.73m2\n* For subjects of childbearing potential: Negative pregnancy test or evidence of post-menopausal status or evidence of permanent surgical sterilization. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Subjects \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution\n  * Subjects ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago\n* Subjects of childbearing potential and subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.1.\n* Recovery to baseline or ≤ Grade 2 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered stable by the treating investigator.\n* Adequate venous access.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* Step 2 Eligibility Confirmation\n\n  * The following criteria must be confirmed within 7 days prior to lymphodepletion. If all criteria are not met, lymphodepletion should be delayed.\n\n    * Confirmation of successful CAR-T manufacturing.\n    * No evidence or suspicion of an infection.\n    * Serum Creatinine ≤ 2 x institutional upper limit of normal (ULN) or eGFR \\>30 ml\u002Fmin\u002F1.73m2\n    * No worsening of clinical status compared to either the initial eligibility criteria that would, in the opinion of the treating physician, significantly increase the risk from lymphodepleting chemotherapy or exclude them from treatment with study CAR-T therapy.\n* Step 3 Eligibility Confirmation\n\n  * The following criteria must be confirmed prior to CAR-T therapy. If all criteria are not met, CAR-T therapy should be delayed.\n\n    * No worsening of clinical status compared to either the initial eligibility criteria that would, in the opinion of the treating physician, significantly increase the risks from treatment with CAR-T therapy.\n    * Confirmation that washout periods outlined in section 6.6 and Appendix 10 have been followed.\n\nExclusion Criteria:\n\n* Autologous or allogeneic stem cell transplant or CAR-T therapy within 6 weeks of planned CAR-T cell infusion.\n* Subjects with active infection that requires systemic treatment\n* History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.\n* Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of child bearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.\n* Receiving other investigational agents.\n* Confirmation that washout periods listed in Appendix 10 have been followed.\n* Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.\n* The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and\u002For will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6). Patients with transformed disease are allowed.\n* Known brain metastases or cranial epidural disease. Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and\u002For surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the first dose of study treatment.\n* Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.\n    * QTc prolongation defined as a QTcF \\> 500 ms.\n    * Known congenital long QT.\n    * Left ventricular ejection fraction \\\u003C 55%.\n    * Uncontrolled hypertension defined as ≥ 140\u002F90 as assessed from the mean of three consecutive blood pressure measurements taken over 10 minutes.\n  * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection\u002Finflammation, intestinal obstruction, unable to swallow medication, \\[subjects may not receive the drug through a feeding tube\\], social\u002F psychological issues, etc.)\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or seropositive HIV. Note: Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.\n* Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).\n* Subjects taking prohibited medications as described in Section 6.6 and Appendix 10. Unless otherwise stated, a washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.\n* Subjects with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.",{"count":107,"type":22},10,[25],"This is an open label, non-randomized, phase 1 study of anti-CD19 CAR-T cells against relapsed CD19 positive NHL, CLL and ALL based in a lymphodepletion regimen (fludarabine and cyclophosphamide) and using a CellReGen-based process for manufacturing CAR-T cells.\n\nThis study will utilize a staggered enrollment design with a safety observation period.",[29,111],"Diffuse Large B Cell Lymphoma",{"date":36,"type":37},{"date":114,"type":37},"2024-02-20",{"date":116,"type":22},"2028-05",{"name":118,"class":97},"University of Utah",{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":17,"minAge":126,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":140},"100483753","phase-1-a-clinical-study-of-mk-1045-cn201-in-people-with-precursor-b-cell-acute-lymphoblastic-leukemia-mk-1045-002-100483753","NCT05579132","A Clinical Study of MK-1045 (CN201) in People With Precursor B-cell Acute Lymphoblastic Leukemia (MK-1045-002)","An Open-label, Multi-center Phase Ib\u002FII Study of MK-1045 (CN201) in Subjects With Precursor B-cell Acute Lymphoblastic Leukemia","The main inclusion criteria include but are not limited to:\n\n* Adult participants must be age 18 or older\n* Pediatric participants must be at least 2 years old and less than 18 years old.\n* Diagnosis of precursor B-cell acute lymphoblastic leukemia (B-ALL) and have more than 5% blasts in the bone marrow by morphological assessment\n* Participants with Ph-negative B-ALL with any of the following refractory\u002Frelapse criteria:\n\n  * Failure to achieve complete remission after initial induction therapy;\n  * Failure to achieve complete remission after salvage treatment;\n  * Relapse with first remission duration ≤12 months\n  * Second or later relapse\n  * Relapse after allogeneic HSCT\n* Participants with Ph-positive B-ALL who have received 2 (or more) tyrosine kinase inhibitors (TKIs) and meet the refractory\u002Frelapse criteria above or, those with the T315I mutation\n\nThe main exclusion criteria include but are not limited to:\n\n* History of Burkitt's leukemia.\n* Received anti-CD19 therapy within 3 months prior to entering the study\n* Received allogeneic HSCT within 12 weeks prior to entering the study\n* Received prior treatment with chimeric antigen receptor T cell (CAR-T) within 3 months prior to entering the study\n* History or presence of clinically relevant central nervous system (CNS) pathology\n* History of clinically symptomatic metastases to the central nervous system or meninges, or other evidence of uncontrolled metastases to the CNS or meninges\n* History of immunodeficiency, including history of any positive test result for human immunodeficiency virus (HIV) antibody.\n* History of serious cardiovascular and cerebrovascular disease\n* Has active autoimmune diseases that may relapse","2 Years",{"count":128,"type":22},203,[25,82],"Researchers are looking for new ways to treat people with a type of blood cancer called precursor B-cell Acute Lymphoblastic Leukemia (B-ALL) that is relapsed- the cancer has come back after treatment, or refractory - the current treatment has stopped working to slow or stop cancer growth. This study will have two parts. In the first part (dose escalation phase) the goal is to learn about the safety of a study treatment, MK-1045, and to find the best dose level of MK-1045 that is tolerated and may work to treat B-ALL. In the second part (Phase II) researchers want to learn how well MK-1045 works to treat B-ALL.",[29],{"date":34,"type":37},{"date":134,"type":37},"2022-11-01",{"date":136,"type":22},"2028-12-31",{"name":138,"class":139},"MSD R&D (China) Co., Ltd.","INDUSTRY",11,{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":153,"conditions":154,"keywords":166,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":4},"100652162","phase-1-a-study-of-sonrotoclax-bgb-11417-in-children-with-relapsed-or-refractory-acute-myeloid-leukemia-and-b-cell-acute-lymphoblastic-leukemia-100652162","NCT07770698","A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia","A Phase 1\u002F2a, Open-Label, Dose Finding and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sonrotoclax (BGB-11417) in Combination With Other Agents in Pediatric Patients Aged 6 Months to 17 Years, With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia","Key Inclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for participation:\n\n1. Have a performance status of Lansky ≥50 for participants ≤16 years of age or Karnofsky ≥50 for participants \\>16 years of age.\n2. Have adequate renal function, defined as an estimated or measured glomerular filtration rate (GFR) ≥60 mL\u002Fmin.\n3. Have adequate hepatic function, defined as:\n\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C2.5 × the institutional upper limit of normal (ULN)\n   * Total bilirubin ≤1.5 × the institutional ULN.\n4. Have minimum cardiac function as defined in the study protocol.\n\nAcute Myeloid Leukemia (AML)-Specific Inclusion Criteria\n\n1. Have a histologically confirmed diagnosis of acute myeloid leukemia (AML) that is relapsed or refractory (R\u002FR) after ≥2 prior lines of systemic therapy.\n2. Have ≥5% blasts in a bone marrow aspirate or biopsy sample, as assessed by morphology. Participants with extramedullary, non-central nervous system (CNS) disease are eligible.\n\nB-Cell Precursor Acute Lymphoblastic Leukemia (ALL)-Specific Inclusion Criteria\n\n1. Have a histologically confirmed diagnosis of B-cell precursor acute lymphoblastic leukemia (ALL) that is R\u002FR after ≥2 prior lines of systemic therapy, including at least 1 line of blinatumomab-based therapy.\n2. Have ≥5% blasts in a bone marrow aspirate or biopsy sample, as assessed by morphology.\n3. Have leukemic blasts expressing cluster of differentiation 22 (CD22) on the cell surface, as assessed by flow cytometry of a bone marrow aspirate.\n\nKey Exclusion Criteria\n\nParticipants will be excluded from participation if any of the following apply:\n\n1. Have central nervous system (CNS) 2 or CNS 3 disease at screening.\n2. Have toxicity from prior anticancer therapy that has not recovered to ≤Grade 1, as defined by the applicable toxicity grading criteria.\n3. Have a history of prior allogeneic stem cell transplantation \\\u003C90 days from enrollment or if if ≥ 90 days from enrollment, with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent.\n\nAML-Specific Exclusion Criteria\n\n1. Have a diagnosis of acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).\n2. Have AML with fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD), as determined by local assessment.\n\nALL-Specific Exclusion Criteria\n\n1. Have Philadelphia chromosome-positive (Ph+) ALL with a breakpoint cluster region::Abelson murine leukemia viral oncogene homolog 1 (BCR::ABL1) fusion.\n2. Have received prior therapy with a B-cell lymphoma 2 (BCL-2) inhibitor.\n\nNote: Other eligibility criteria may apply.","6 Months","17 Years",{"count":151,"type":22},30,[25,82],"The goal of this clinical trial is to learn if sonrotoclax (BGB-11417) is safe and may help treat children and adolescents with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has come back after treatment or has not responded to treatment. The study will also learn how the body processes sonrotoclax when it is given with other medicines. The main questions it aims to answer are:\n\n* Is sonrotoclax safe and well tolerated when given with other anti-cancer medicines?\n* How does the body absorb, process, and remove sonrotoclax?\n* Does treatment with sonrotoclax, in combination with other medicines, help reduce or eliminate leukemia?\n\nResearchers will give sonrotoclax together with other anti-cancer medicines to participants with relapsed or refractory AML or ALL. Participants will:\n\n* Take sonrotoclax in combination with other anti-cancer medicines\n* Have regular clinic visits for physical exams, blood tests, heart monitoring, and other safety assessments.\n* Provide blood samples to measure how the body processes sonrotoclax.\n* Have tests to evaluate how their leukemia responds to treatment.\n* Continue treatment as long as it is helping and side effects remain manageable, according to the study plan.",[155,156,157,158,159,160,161,162,29,163,164,165],"Relapsed Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","B-cell Acute Lymphoblastic Leukemia","Pediatric Cancer","Pediatric ALL, Relapsed","Pediatric ALL","Pediatric ALL, B Cell","Acute Myeloid Leukemia","Pediatric AML","R\u002FR AML","R\u002FR B-cell ALL",[165,164,163,29,162,161,160,159,158,155,156,167,168],"Sonrotoclax","Pediatric","2026-08-17",{"date":171,"type":37},"2026-08-18",{"date":173,"type":22},"2026-10",{"date":175,"type":22},"2031-09",{"name":177,"class":139},"BeOne Medicines",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":185,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":189,"conditions":190,"keywords":194,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":45},"100610438","phase-2-all-backbone-in-ayas-100610438","NCT07227584","ALL Backbone in AYAs","Treatment of Newly Diagnosed Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia in Adolescents and Young Adults (AYAs)","Inclusion Criteria:\n\n3.1.1Confirmed diagnosis of Philadelphia chromosome-negative acute lymphoblastic leukemia.\n\n* Diagnosis should be made by peripheral blood, bone marrow aspirate, bone marrow biopsy, or tissue biopsy demonstrating ≥25% involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-ALL or T-ALL.\n\n  o Participants with B-cell and T-cell lymphoblastic lymphoma are eligible regardless of bone marrow involvement Participants with mixed phenotype acute leukemia (MPAL) ARE eligible, if an ALL regimen is felt to be most appropriate treatment.\n* Participants with CNS leukemia ARE eligible. 3.1.2 Allowed prior therapy:\n* Corticosteroids, hydroxyurea, all-trans retinoic acid (ATRA).\n* IT chemotherapy.\n* Emergent radiation therapy or leukapheresis for life threatening complications.\n* One cycle of prior chemotherapy (i.e. an induction cycle given at another institution and participant transfers care for post-induction treatment; OR a participant does not meet eligibility prior to induction but does meet eligibility after remission induction).\n\n3.1.3 Age 18.00 - 50.99 years 3.1.4 Direct bilirubin \\\u003C1.4 mg\u002FdL (total bilirubin \\\u003C 1.4 mg\u002FdL is acceptable). 3.1.5 Willingness to use effective means of birth control. The effects of chemotherapy on the developing human fetus are unknown. For this reason and because therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study.\n\n3.1.6 Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nPhiladelphia chromosome-positive \u002F BCR::ABL1 fusion 3.2.2 Participants with mature B-cell (Burkitt's) ALL. Mature B-cell ALL is defined by the presence of surface immunoglobulin AND any of the following: t(8;14)(q24;q32), t(8;22), t(2;8), or c-myc-gene rearrangement by FISH, PCR or other testing. \\[FISH\u002FPCR testing for c-myc rearrangements is not required prior to study entry, but it is suggested for participants with surface immunoglobulin expression or L3 morphology\\]. 3.2.3 Participants with acute undifferentiated leukemia. 3.2.4 Participants receiving any other investigational agent for this condition.\n\n3.2.5 Uncontrolled intercurrent illness including but not limited to ongoing infection with vital sign instability (hypotension, respiratory insufficiency), life-threatening acute tumor lysis syndrome (e.g., with renal failure), symptomatic congestive heart failure, cardiac arrhythmia, intracranial or other uncontrolled bleeding. Circumstances that may significantly interfere with a participant's ability to safely comply with study procedures, such as attend scheduled study visits, adhere to treatment protocols, or complete study assessments. These include a lack of reliable transportation, unstable housing, or psychiatric illness, but reasonable attempts should be made to overcome these circumstances, including but not limited to identifying sponsor, institutional, or thirdparty financial or social support as well as psychiatric consultation for objective assessment. 3.2.6 Sexually active participants of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation are ineligible.\n\n3.2.7 Pregnant women are excluded from this study because many of the agents used on this protocol have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these chemotherapy agents, breastfeeding should be discontinued if the mother is enrolled.","51 Years",{"count":187,"type":22},67,[82],"The goal of this research study is to evaluate a chemotherapy regiment for the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs).\n\nThe names of the study drugs involved in this study are:\n\n* blinatumomab (a type of immunotherapy drug)\n* cyclophosphamide (a type of chemotherapy drug)\n* cytarabine (a type of antineoplastic agent)\n* dexamethasone (a type of synthetic glucocorticoid)\n* doxorubicin (a type of antineoplastic agent)\n* etoposide (a type of antineoplastic agent)\n* mercaptopurine (a type of antineoplastic agent)\n* methotrexate (a type of chemotherapy drug)\n* pegaspargase (a type of antineoplastic agent)\n* vincristine (a type of antineoplastic agent)",[29,191,192,193],"Philadelphia Chromosome-Negative Lymphoblastic Leukemia","Acute Lymphoblastic Leukemia (ALL)","Leukemia",[29,195,192,193],"Philadelphia Chromosome-Negative lymphoblastic leukemia","2026-08-14",{"date":169,"type":37},{"date":199,"type":37},"2026-04-03",{"date":201,"type":22},"2035-07-31",{"name":203,"class":97},"Dana-Farber Cancer Institute",{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":149,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":187},"100496740","phase-2-a-study-to-learn-more-about-the-study-medicine-called-inotuzumab-ozogamicin-ino-in-children-1-to-18-years-with-first-relapse-all-100496740","NCT05748171","A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to \u003C18 Years) With First Relapse ALL","A PROSPECTIVE, RANDOMIZED, OPEN-LABEL PHASE 2 STUDY TO EVALUATE THE SUPERIORITY OF INOTUZUMAB OZOGAMICIN MONOTHERAPY VERSUS ALLR3 FOR INDUCTION TREATMENT OF CHILDHOOD HIGH-RISK OR VERY HIGH-RISK FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA","Inclusion Criteria:\n\n1. Male or female participants between 1 and \\\u003C18 years of age.\n2. Morphologically confirmed diagnosis of first relapse HR or VHR BCP ALL; HR first relapse is defined as relapse occurring within 18 to 30 months of original diagnosis of ALL or within 6 months of completion of primary therapy, and lacking any identified very high-risk genetic abnormalities (Groeneveld-Krentz et al, 2019) (ie, KMT2A::AFF1 fusion \\[t(4;11)(q21;q23)\\], TCF3-HLF fusion \\[t(17;19)(q22;p13)\\], TCF3-PBX1 fusion \\[t(1;19)(q23;p13.3)\\], hypodiploidy \\[\\\u003C40 chromosomes\\] or masked low hypodiploidy (Molina et al, 2021), TP53 alteration). VHR first relapse is defined as relapse within 18 months of original diagnosis of ALL and\u002For with any of the following genetic abnormalities at original diagnosis or at relapse (Groeneveld-Krentz et al, 2019) (ie, KMT2A::AFF1 fusion \\[t(4;11)(q21;q23)\\], TCF3-HLF fusion \\[t(17;19)(q22;p13)\\], TCF3-PBX1 fusion \\[t(1;19)(q23;p13.3)\\], hypodiploidy \\[\\\u003C40 chromosomes\\] or masked low hypodiploidy (Molina et al, 2021), TP53 alteration).\n\n   * CD22-positive ALL as defined by local institution;\n   * Bone marrow involvement of ≥ 5% leukemic blasts (≥ M2 status).\n3. Adequate serum chemistry parameters:\n\n   * An eGFR in participants 1 to \\\u003C2 years of age, or eCrCl in those 2 to \\\u003C18 years of age, ≥30 mL\u002Fmin using the recommended formula in Section 10.10.2.\n   * AST and ALT ≤5 × institutional ULN at the time of randomization or pre-cytoreduction\u002Fgeneral anesthesia; (Refer to Appendix 9 for France-specific requirement on the ALT\u002FAST threshold);\n   * Total bilirubin ≤1.5 × institutional ULN unless the participant has documented Gilbert's syndrome;\n4. Prior history of thrombosis during corticosteroid use and\u002For asparaginase are eligible provided the patient receives anti-coagulant prophylaxis per institutional guidelines.\n5. Cardiac shortening fraction ≥ 30% by echocardiogram or ejection fraction \\>50% by MUGA.\n\n6 Participants with combined bone marrow and testicular relapse are eligible assuming orchiectomy is performed prior to randomization or is planned at the end of induction therapy.\n\n5.2. Exclusion Criteria\n\n1. Any history of prior or ongoing hepatic SOS or prior liver failure \\[defined as severe acute liver injury with encephalopathy and impaired synthetic function (INR of ≥1.5)\\].\n2. Prior allo-HSCT or CAR T-cell therapy.\n3. Isolated extramedullary leukemia.\n4. Philadelphia-chromosome positive ALL, ie. BCR-ABL\u002Ft(9;22) present.\n5. Prior therapy with a calicheamicin-conjugated antibody (eg, InO or gemtuzumab ozogamicin).\n6. Participants with active, uncontrolled bacterial, fungal, or viral infection.\n7. Hypersensitivity\u002Fallergy to both PEG-ASP and Erwinia-ASP",{"count":212,"type":22},100,[82],"This prospective, randomized, multicenter, open-label Phase 2 study is designed to evaluate the superiority of InO monotherapy vs ALLR3 after 1 cycle of induction treatment in paediatric participants (between 1 and \\\u003C18 years) with High Risk (HR) or very high risk (VHR) first bone marrow relapse CD22-positive BCP ALL, and to evaluate the safety and tolerability, PK and long-term efficacy. Treatment with study intervention will end after induction therapy; follow-up will continue for up to 5 years from randomization.",[216],"ACUTE LYMPHOBLASTIC LEUKEMIA",[17,218,219,220,193,221],"BCP ALL","High risk BCP ALL","Relapse ALL","Very high risk BCP ALL","2026-08-13",{"date":196,"type":37},{"date":225,"type":37},"2023-05-17",{"date":227,"type":22},"2036-05-25",{"name":229,"class":139},"Pfizer",{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":45},"100607721","phase-2-phase-2-study-to-assess-the-safety-and-efficacy-of-subcutaneous-blinatumomab-in-patients-with-measurable-residual-disease-positive-b-cell-acute-lymphoblastic-leukemia-100607721","NCT07192237","Phase 2 Study to Assess the Safety and Efficacy of Subcutaneous Blinatumomab in Patients With Measurable Residual Disease Positive B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria\n\n* Participants of age ≥18 years with documented B-cell ALL with recurrent or persistent MRD (at a sensitivity of 10-6) while in morphological remission (Includes Ph-, Ph+ and Ph-like).\n* ECOG Performance status of 0, 1, or 2.\n* Adequate organ function with creatinine less than or equal to 1.6 mg\u002Fdl, bilirubin less than or equal to 3.5 mg\u002Fdl and ALT and\u002For AST less than or equal to 5 times institutional upper limit of normal.\n* The effects of blinatumomab on the developing human fetus are unknown. For this reason and because bispecific T-cell engager agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female Participants, between the onset of menses (as early as 8 years of age) and 55 years unless the Participant presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of blinatumomab administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Pregnant women are excluded from this study because Blinatumomab, a bispecific T-cell engager agent has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with blinatumomb, breastfeeding should be discontinued if the mother is treated with blinatumomab. These potential risks may also apply to other agents used in this study.\n* Women of child-bearing potential (WOCBP) must have negative urine or serum pregnancy test within 1 week of study therapy initiation. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization.\n* Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 4 months after the last dose of protocol specified therapy.\n* Symptomatic CNS leukemia\n* History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (≥ grade 3) CNS events including ICANS from prior CART or other T cell engager therapies.\n* Isolated extramedullary B-cell ALL\n* Current autoimmune disease or history of autoimmune disease with potential CNS involvement.\n* Active acute or chronic graft versus host disease post-allogeneic HSCT requiring systemic treatment with immunosuppressive medication.\n* Prior history of therapy with SQ blinatumomab for R\u002FR B-cell as part of a clinical trial (but not prior therapy with IV blinatumomab)\n* Known hypersensitivity to blinatumomab or to any component of the product formulation\n* Uncontrolled HIV, HBV, HCV infections\n* Active and uncontrolled disease\u002Finfection as judged by the treating physician.\n* Unable or unwilling to sign the consent form.\n* No other investigational therapy within the past 14 days\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.",{"count":80,"type":22},[82],"To find out if giving blinatumomab as injections under the skin can help to control MRD and keep the disease from coming back in participants with B-cell ALL.",[240,241,29],"Phase 2 Study","Blinatumomab","2026-08-10",{"date":244,"type":37},"2026-08-12",{"date":246,"type":22},"2026-09-27",{"date":248,"type":22},"2032-10-12",{"name":250,"class":97},"M.D. Anderson Cancer Center",{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":258,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":45},"100540914","medsupport-intervention-to-identify-and-address-barriers-to-pediatric-medication-adherence-100540914","NCT06323044","MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence","MedSupport: A Novel Multilevel Intervention to Identify and Address Barriers to Pediatric Medication Adherence","Inclusion Criteria:\n\n* Parent of a child diagnosed with acute lymphoblastic leukemia (ALL)\n* Child patient age 365 days to \\\u003C 19 years at time of study entry.\n* Parent's child patient's therapy must include 6-mercaptopurine (6-MP) administered orally or by nasogastric (NG) tube.\n* Verbal fluency in English, or Spanish\n* Parent has a smartphone or computer access with an Internet connection.\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* Parent is unwilling or unable to follow protocol requirements.",true,{"count":260,"type":22},150,[58],"This clinical trial identifies and addresses barriers to pediatric medication adherence among families of children with acute lymphoblastic leukemia. Pediatric nonadherence (noncompliance) to medication is a significant public health problem, and rigorous research repeatedly documents that nonadherence increases risk for hospitalization, healthcare cost, disease progression, and death. Pediatric acute lymphoblastic leukemia (ALL) patients who miss 5% of 6-mercaptopurine (6-MP) doses within the 2-year 6-MP regimen have a 2.7-fold risk of cancer that comes back after a period of improvement (relapse). To address these families' needs, researchers have developed MedSupport, a theory-based multilevel intervention with targets at the organizational, healthcare team, and caregiver levels that is designed to address root barriers to medication adherence. This study is being done to better understand families' experiences giving their child oral chemotherapy at home and to help families cope with the day-to-day challenges of giving their child medication.",[29],{"date":244,"type":37},{"date":266,"type":37},"2025-02-11",{"date":268,"type":22},"2029-03-31",{"name":270,"class":97},"Roswell Park Cancer Institute",{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":278,"enrollmentInfo":279,"targetDuration":280,"studyType":281,"phases":4,"briefSummary":282,"conditions":283,"keywords":291,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":45},"100651557","low-dose-liposomal-amphotericin-b-for-antifungal-prophylaxis-in-prolonged-neutropenia-patients-100651557","NCT07763054","Low-dose Liposomal Amphotericin B for Antifungal Prophylaxis in Prolonged Neutropenia Patients","Evaluation of Low-Dose Liposomal Amphotericin B for Prophylaxis of Invasive Fungal Infections in Patients With Prolonged Neutropenia: A Clinical Study","Inclusion Criteria:\n\n* Age 18 to 75 years (inclusive), both sexes.\n* Meets NCCN 2025 V1 guideline criteria for high-risk invasive fungal disease, including allogeneic hematopoietic stem cell transplantation, autologous hematopoietic cell transplantation with mucosal damage, acute leukemia, grade 3\u002F4 graft-versus-host disease, myelodysplastic syndrome, lymphoma, multiple myeloma, chronic lymphocytic leukemia, treatment with purine analogues (fludarabine, clofarabine, nelarabine), chimeric antigen receptor (CAR) T-cell therapy, alemtuzumab therapy, with expected neutropenia \\>7 days and accompanied by agranulocytosis.\n\nNote: Agranulocytosis is defined as absolute neutrophil count ≤0.5×10\\^9\u002FL, or absolute neutrophil count ≤1×10\\^9\u002FL with expected decline to ≤0.5×10\\^9\u002FL within 48 hours.\n\n* Assessed by the study physician as having high-risk for invasive fungal infection, intolerant or unable to use other antifungal agents due to toxicity or other reasons, and the treating physician has independently decided in routine clinical practice to initiate liposomal amphotericin B for antifungal prophylaxis for 3-5 days, with the selected dosage regimen of 50 mg\u002Fday, intravenous, once daily.\n* Patient or legally authorized representative has voluntarily signed the informed consent form.\n\nExclusion Criteria:\n\n* Allergy to any component of liposomal amphotericin B, or development of serious adverse events during the initial 3-5 days of prophylactic use.\n* Prior history of proven or probable invasive fungal disease (IFD).\n* Presence of pneumonia, unexplained fever, or clinical\u002Fimaging evidence suggestive of or diagnosed as fungal infection during screening.\n* Clinically significant hypokalemia (defined as serum potassium \\\u003C3.2 mmol\u002FL, or below the lower limit of normal while receiving digitalis therapy) that cannot be corrected before starting trial treatment.\n* Hepatic dysfunction with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥5× upper limit of normal (ULN), or total bilirubin ≥3× ULN.\n* Renal impairment requiring or currently undergoing hemodialysis or peritoneal dialysis.\n* New York Heart Association (NYHA) Class III\u002FIV heart failure.\n* Positive for human immunodeficiency virus (HIV) antibody or Treponema pallidum hemagglutination assay (TPHA).\n* Expected survival \\\u003C3 months.\n* Pregnant or breastfeeding women, or women of childbearing potential who are not using contraception and planning pregnancy.\n* Any other condition that the investigator considers inappropriate for participation in the clinical trial.","75 Years",{"count":151,"type":22},"7 Days","OBSERVATIONAL","This is a single-center, single-arm, observational clinical study evaluating the efficacy and safety of low-dose liposomal amphotericin B (50 mg\u002Fday, intravenous, once daily) for the prevention of invasive fungal infections in adult patients (aged 18-75 years) with hematological malignancies who develop prolonged neutropenia (absolute neutrophil count ≤0.5×10\\^9\u002FL, expected to last \\>7 days) and are at high risk for invasive fungal disease. Participants are those who, per the treating physician's routine clinical decision, have been initiated on liposomal amphotericin B prophylaxis at 50 mg\u002Fday due to intolerance or toxicity to other antifungal agents. The primary outcome is the incidence of proven or probable invasive fungal disease. Secondary outcomes include incidence of pneumonia, persistent unexplained fever \\>4 days, use of additional systemic antifungal therapy, and adverse events. A total of 30 participants will be enrolled. Data will be collected at baseline, during treatment, and within 7 days after treatment completion.",[162,29,284,285,286,287,288,289,290],"Myelodysplastic Syndrome","Lymphoma","Multiple Myeloma","Chronic Lymphocytic Leukemia","Neutropenia","ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION","Invasive Fungal Infections",[292,293,294,295,296],"Liposomal Amphotericin B","Antifungal Prophylaxis","Invasive Fungal Disease","Prolonged Neutropenia","Hematological Malignancies","2026-08-08",{"date":222,"type":37},{"date":300,"type":37},"2025-08-01",{"date":302,"type":22},"2026-11-30",{"name":304,"class":97},"Haikou Affiliated Hospital of Central South University Xiangya School of Medicine",{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":312,"enrollmentInfo":313,"targetDuration":4,"studyType":23,"phases":315,"briefSummary":316,"conditions":317,"keywords":321,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":45},"100507421","feasibility-and-safety-of-collecting-and-combining-autologous-hematopoietic-stem-cells-with-chimeric-antigen-receptor-car-t-cell-therapy-in-subjects-with-relapsedrefractory-hematological-malignancies-100507421","NCT05887167","Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells With Chimeric Antigen Receptor (CAR) T-Cell Therapy in Subjects With Relapsed\u002FRefractory Hematological Malignancies","IIT2022-04-Sasine-CAR-T: A Phase 1 Single-arm, Open-label Study to Evaluate the Feasibility and Safety of Collecting and Combining Autologous Hematopoietic Stem Cells With Chimeric Antigen Receptor (CAR) T-Cell Therapy in Subjects With Relapsed\u002FRefractory Hematological Malignancies","Inclusion Criteria:\n\n* Age 18 - 85 years.\n* Histologically proven hematological malignancy according to the World Health Organization 2016 classification criteria for which a commercially available, FDA-approved CAR T product exists.\n* Relapsed or refractory disease, defined by the following:\n\n  * Disease progression after last regimen, or\n  * Refractory disease: failure to achieve a partial response (PR) or complete remission (CR) to the last regimen\n* At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy for the malignancy at the time the subject is planned for leukapheresis.\n* Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1 with the exception of alopecia.\n* Subjects with an active uncontrolled infection should not start CAR T treatment until the infection has resolved.\n* Eastern cooperative oncology group (ECOG) performance status 0 - 2.\n* Adequate hematologic, hepatic, and cardiac function\n* Serum pregnancy test for women of childbearing potential (WOCBP) at Screening.\n* Willing to comply to research specimen collection as specified in the protocol.\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Autologous hematopoietic cell transplant intent or execution within 8 weeks of planned CAR T infusion.\n* History of allogeneic cell transplantation within 8 weeks of planned CAR T infusion.\n* Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management at time of screening.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment.\n* History of a seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, or any autoimmune disease with CNS involvement.\n* Doses of corticosteroids of greater than or equal to 5 mg\u002Fday of prednisone or equivalent doses of other corticosteroids and other immunosuppressive drugs are not allowed prior to enrollment. A washout period of 10 days prior to leukapheresis and 10 days prior to anti-CD19 CAR T cell administration is required.\n* Any medical condition likely to interfere with assessment of feasibility or safety of study treatment.\n* Live vaccine ≤ 6 weeks prior to planned start of conditioning regimen.\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n* Current pregnancy or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.\n* Subjects of both sexes who are not willing to practice birth control from the time of consent through 6 months after the completion of conditioning chemotherapy. Females who have undergone surgical sterilization or who have been postmenopausal for at least 1 year are not considered to be of childbearing potential.\n* In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.\n* Patients with obvious myeloid clonal hematopoiesis on the screening bone marrow biopsy will be excluded based on the risk of developing myeloid neoplasms with aHSC infusion.","85 Years",{"count":314,"type":22},20,[25],"The study is designed to examine the feasibility and safety of collecting autologous hematopoietic stem cells (HSCs) to be combined with CAR T-cell therapy for patients with relapsed\u002Frefractory (r\u002Fr) hematological disease. The study will evaluate feasibility of collecting the target dose of HSCs from at least 50% of enrolled patients. The study will assess safety based on incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in the first 60 days post CAR T dosing, and also through the collection of adverse events (AEs) and serious adverse events (SAEs) as well as the durability of response after treatment with HSCs with CAR T. The study follows an open-label, single-center and single non-randomized cohort design. 20 subjects with r\u002Fr hematological malignancies will be enrolled and treated to evaluate the feasibility and preliminary safety of collecting autologous HSCs and combining them with CAR T-cell therapy.",[318,319,29,320,286,111],"Hematologic Malignancy","Large B-cell Lymphoma","Mantle Cell Lymphoma",[322,323,324,325],"CAR T-cell therapy","autologous hematopoietic stem cells","CAR T","CAR T therapy","2026-08-06",{"date":242,"type":37},{"date":329,"type":37},"2024-03-02",{"date":331,"type":22},"2027-12-15",{"name":333,"class":97},"Joshua Sasine, MD, PhD",{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":17,"minAge":341,"maxAge":18,"enrollmentInfo":342,"targetDuration":4,"studyType":281,"phases":4,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":351,"locationsCount":45},"100650804","plasma-ctdna-monitoring-in-pediatric-acute-leukemia-100650804","NCT07751588","Plasma ctDNA Monitoring in Pediatric Acute Leukemia","A Retrospective-Prospective Observational Cohort Study of Peripheral Blood Plasma ctDNA Compared With Bone Marrow MFC-MRD, ddPCR, and RNA Sequencing in Pediatric Acute Leukemia","Inclusion Criteria:\n\n1. Patients diagnosed with pediatric acute leukemia, including acute lymphoblastic leukemia, acute myeloid leukemia, or mixed phenotype acute leukemia.\n2. Age younger than 18 years at diagnosis.\n3. Availability of peripheral blood plasma cfDNA\u002FctDNA testing data.\n4. Availability of clinical data and at least one corresponding bone marrow-based assessment, including MFC-MRD, ddPCR, RNA sequencing.\n5. For prospectively collected follow-up data or samples, written informed consent will be obtained from parents or legal guardians.\n6. For retrospectively collected data, consent procedures will follow the approval of the institutional ethics committee.\n\nExclusion Criteria:\n\n1. Patients without available peripheral blood plasma cfDNA\u002FctDNA data.\n2. Patients with insufficient clinical or laboratory data for analysis.\n3. Samples failing cfDNA\u002FctDNA quality control.\n4. Withdrawal of consent for prospective follow-up or additional sample collection.\n5. Patients judged by the investigator to be unsuitable for inclusion.","3 Years",{"count":7,"type":22},"This retrospective-prospective observational cohort study aims to evaluate peripheral blood plasma circulating tumor DNA (ctDNA) dynamics in pediatric acute leukemia and compare ctDNA results with concurrent bone marrow multiparameter flow cytometry minimal residual disease (MFC-MRD), droplet digital PCR (ddPCR), and RNA sequencing findings. The study includes a retrospective cohort with available clinical and molecular data and a prospective cohort with serially collected peripheral blood and bone marrow samples at predefined treatment time points. The study will assess consistence between plasma ctDNA and conventional bone marrow-based assays, characterize longitudinal ctDNA dynamics, and explore the association between ctDNA patterns and relapse or survival outcomes.",[162,29],"2026-08-05",{"date":347,"type":37},"2026-08-07",{"date":349,"type":22},"2026-07-11",{"date":68,"type":22},{"name":352,"class":97},"Institute of Hematology & Blood Diseases Hospital, China",{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":369,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":45},"100621498","mb-cart191-in-relapsedrefractory-acute-lymphoblastic-leukemia-100621498","NCT07371403","MB-CART19.1 in Relapsed\u002FRefractory Acute Lymphoblastic Leukemia","MB-CART19.1 in Patients With Relapsed\u002FRefractory CD19-positive B Cell Acute Lymphoblastic Leukemia: A Feasibility Study","Inclusion Criteria:\n\n* Age ≥ 1 year as long as if deemed fit by treating investigator\n* CD19 expression must be detected (≥20%) on the malignant cells by flow cytometry.\n* Patients with relapsed or refractory disease with 0.01% or higher blasts in the bone marrow, or patients with confirmed disease progression as demonstrated by FDG PET-CT or CT\u002FMRI of the affected lymph node or spleen after at least 2 cycles\u002Flines of chemotherapy are eligible for enrollment. For patients with Philadelphia-positive disease, a second-generation or higher TKI must have been utilized in one of the treatment lines.\n* Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active graft vs host disease, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.\n* Estimated life expectancy \\> 12 weeks\n* Karnofsky or Lansky (age dependent) performance score ≥ 60\n* Patients and\u002For parents must give their written informed consent\u002Fassent.\n* CNS and\u002For testicular involvement are allowed, only if cleared and in the presence of systemic involvement.\n\nExclusion Criteria:\n\n* Rapidly progressive, uncontrolled disease as assessed by the treating physician and\u002For principal investigator.\n* Persistent extramedullary disease.\n* Isolated CNS and\u002For testicular disease.\n* Current autoimmune disease, or history of autoimmune disease with potential CNS involvement\n* Active hepatitis B, C or HIV\n* Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis)\n* History of an additional malignancy (≤ 3 years) other than non-melanoma skin cancer or carcinoma in situ.\n* Pulmonary function: Patients with pre-existing severe lung disease (FEV1 or FVC \\\u003C 65%) or an oxygen requirement of \\>28% O2 FiO2 or active pulmonary infection.\n* Cardiac function: Left ventricular ejection fraction \\\u003C50% by echocardiography\n* Renal function: Creatinine clearance \\\u003C50 mL\u002Fmin\u002F1.73 m2\n* Liver function: patients with serum bilirubin ≥3 times upper limit of or AST or ALT \\> 5 times upper limit of normal, unless due to leukemic liver infiltration as determined by the investigators.\n* Pregnant or breast-feeding females\n* Medications: systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing (\\\u003C0.5 mg\u002Fkg\u002Fday of methylprednicone), tyrosine kinase inhibitors (TKI) within 7 days prior to leukapheresis, Fludarabine\u002Fclofarabine or immunosuppressive drugs and antibodies (e.g. rituximab, blinatumomab) or investigational drugs or donor lymphocyte",{"count":361,"type":22},12,[58],"Single-arm, prospective, open-label feasibility study evaluating the technical and operational feasibility of manufacturing autologous CD19-directed CAR-T cells (MB-CART19.1) at the point of care for the treatment of relapsed or refractory B-ALL in pediatric and adult patients.",[29,365,366,367,368],"Acute Lymphoblastic Leukemia Recurrent","Acute Lymphoblastic Leukemia Refractory","Acute Lymphoblastic Leukemia Not Having Achieved Remission","Acute Lymphoblastic Leukemia With Failed Remission",[370,371,17,372,373,374],"CAR-T","MB-CART19.1","acute lymphoblastic leukemia","relapsed acute lymphoblastic leukemia","refractory acute lymphoblastic leukemia","2026-08-04",{"date":345,"type":37},{"date":378,"type":37},"2026-02-20",{"date":380,"type":22},"2029-01",{"name":382,"class":97},"King Hussein Cancer Center",{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":258,"sex":17,"minAge":78,"maxAge":278,"enrollmentInfo":390,"targetDuration":4,"studyType":281,"phases":4,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":453,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":460},"100464928","collecting-blood-samples-from-patients-with-and-without-cancer-to-evaluate-tests-for-early-cancer-detection-100464928","NCT05334069","Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection","Blinded Reference Set for Multicancer Early Detection Blood Tests","Inclusion Criteria:\n\n* Participants with a cancer diagnosis: Documentation of disease:\n\n  * Histologic documentation: Histologically confirmed diagnosis of invasive cancer\n  * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma\n\n    * For leukemia: Type (chronic lymphocytic leukemia \\[CLL\\], chronic myeloid leukemia \\[CML\\], acute lymphoblastic lymphoma \\[ALL\\], acute myeloid leukemia \\[AML\\])\n    * For lymphoma: Stage I-IV based on Ann Arbor staging\n    * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)\n  * One of the following tumor types:\n\n    * Colorectal\n    * Bladder\n    * Head and neck\n    * Hepatobiliary\n    * Lung\n    * Lymphoma\n    * Leukemia\n    * Ovary \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Pancreas \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Multiple myeloma\n    * Gastric, esophageal or gastroesophageal\n    * Breast\n    * Thyroid\n    * Kidney\n\n      * For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Endometrium\n    * Prostate\n    * Melanoma\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Sarcoma\n* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention\n* Participants with a cancer diagnosis: Age \\>= 40 and =\\\u003C 75\n* Participants with a cancer diagnosis: No known current pregnancy by self-report\n* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a cancer diagnosis: Willingness to provide blood samples for research use\n* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a cancer diagnosis: No history of organ transplantation\n* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants without a cancer diagnosis and without suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report\n* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)\n* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use\n* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation\n* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, or melanoma by clinical and\u002For radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw\n\n  \\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma\n* Participants with a high suspicion of cancer: Central review of radiology reports and\u002For clinical documentation conducted by study chairs\n* Participants with a high suspicion of cancer: Age \\>= 40 and =\\\u003C 75\n* Participants with a high suspicion of cancer: No known current pregnancy by self-report\n* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) other than the current cancer diagnosis\n* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use\n* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a high suspicion of cancer: No history or organ transplantation\n* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \\* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages",{"count":391,"type":22},2000,"This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.",[29,162,394,395,396,397,287,398,399,400,401,402,403,404,405,406,407,408,409,410,411,412,413,414,415,416,417,418,419,420,421,422,423,424,425,426,427,428,429,430,431,432,433,434,435,436,437,438,439,440,441,442,443,444,445,446,447,448,449,450,451,452],"Ann Arbor Stage I Lymphoma","Ann Arbor Stage II Lymphoma","Ann Arbor Stage III Lymphoma","Ann Arbor Stage IV Lymphoma","Chronic Myeloid Leukemia","Gastroesophageal Junction Adenocarcinoma","Head and Neck Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Invasive Breast Carcinoma","Kidney Carcinoma","Malignant Hepatobiliary Neoplasm","Malignant Solid Neoplasm","Melanoma","Muscle-Invasive Bladder Carcinoma","RISS Stage I Plasma Cell Myeloma","RISS Stage II Plasma Cell Myeloma","RISS Stage III Plasma Cell Myeloma","Sarcoma","Stage I Bladder Cancer AJCC v6 and v7","Stage I Breast Cancer AJCC v7","Stage I Colorectal Cancer AJCC v6 and v7","Stage I Esophageal Cancer AJCC V7","Stage I Gastric Cancer AJCC V7","Stage I Lung Cancer AJCC v7","Stage I Ovarian Cancer AJCC v6 and v7","Stage I Pancreatic Cancer AJCC v6 and v7","Stage I Prostate Cancer AJCC v7","Stage I Uterine Corpus Cancer AJCC v7","Stage II Bladder Cancer AJCC v6 and v7","Stage II Breast Cancer AJCC v6 and v7","Stage II Colorectal Cancer AJCC v7","Stage II Esophageal Cancer AJCC v7","Stage II Gastric Cancer AJCC v7","Stage II Lung Cancer AJCC v7","Stage II Ovarian Cancer AJCC v6 and v7","Stage II Pancreatic Cancer AJCC v6 and v7","Stage II Prostate Cancer AJCC v7","Stage II Uterine Corpus Cancer AJCC v7","Stage III Bladder Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage III Colorectal Cancer AJCC v7","Stage III Esophageal Cancer AJCC v7","Stage III Gastric Cancer AJCC v7","Stage III Lung Cancer AJCC v7","Stage III Ovarian Cancer AJCC v6 and v7","Stage III Pancreatic Cancer AJCC v6 and v7","Stage III Prostate Cancer AJCC v7","Stage III Uterine Corpus Cancer AJCC v7","Stage IV Bladder Cancer AJCC v7","Stage IV Breast Cancer AJCC v6 and v7","Stage IV Colorectal Cancer AJCC v7","Stage IV Esophageal Cancer AJCC v7","Stage IV Gastric Cancer AJCC v7","Stage IV Lung Cancer AJCC v7","Stage IV Ovarian Cancer AJCC v6 and v7","Stage IV Pancreatic Cancer AJCC v6 and v7","Stage IV Prostate Cancer AJCC v7","Stage IV Uterine Corpus Cancer AJCC v7","Thyroid Gland Carcinoma",{"date":345,"type":37},{"date":455,"type":37},"2022-08-18",{"date":457,"type":22},"2027-02-28",{"name":459,"class":97},"Alliance for Clinical Trials in Oncology",744,{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":469,"targetDuration":471,"studyType":281,"phases":4,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":483},"100276031","gmall-registry-and-collection-of-biomaterial-prospective-data-collection-regarding-diagnosis-treatment-and-outcome-of-adult-acute-lymphoblastic-leukemia-all-patients-and-related-diseases-associated-with-a-prospective-collection-of-biomaterial-100276031","NCT02872987","GMALL Registry and Collection of Biomaterial: Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult Acute Lymphoblastic Leukemia (ALL) Patients and Related Diseases Associated With a Prospective Collection of Biomaterial","Prospective Data Collection Regarding Diagnosis, Treatment and Outcome of Adult ALL Patients and Related Diseases Associated With a Prospective Collection of Biomaterial","GMALLregistry","Inclusion Criteria:\n\n* Acute Lymphoblastic Leukemia (All Subtypes) if treated according to ALL protocols\n* Other Types of Leukemia (NK Cell Lymphoma\u002FLeukemia, Biphenotypic Acute Leukemia) if treated according to ALL protocols\n* Non-Hodgkin's Lymphoma of Following Subtypes: Burkitt Lymphoma, B Cell Lymphoma, B- or T-lineage Lymphoblastic Lymphoma, Anaplastic Large Cell Lymphoma, Other NHL) if treated according to B-ALL protocols\n* Age minimum 18 yrs",{"count":470,"type":22},10000,"15 Years","The GMALL registry serves the purpose of ALL research and quality assurance. The Registry collects data about diagnostics, treatment and outcome of Adult ALL Patients in the clinical routine, whether or not the patient is treated within a clinical trial.",[29,193,474],"Non-Hodgkin's Lymphoma","2026-08-03",{"date":345,"type":37},{"date":478,"type":4},"2009-02",{"date":480,"type":22},"2035-12",{"name":482,"class":97},"Goethe University",147,{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":258,"sex":17,"minAge":491,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":23,"phases":493,"briefSummary":494,"conditions":495,"keywords":499,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":45},"100643735","strength-training-exercise-in-pediatric-acute-lymphoblastic-leukemia-and-lymphoblastic-lymphoma-step-all-100643735","NCT07634653","Strength Training Exercise in Pediatric Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (STEP-ALL)","STEP-ALL","Inclusion Criteria for children:\n\nAll subjects must meet the following criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. OR Written assent and parental\u002Flegal guardian consent.\n* Age \\>= 6 and \\\u003C =21 years at the time of diagnosis.\n* Newly- diagnosed with one of the following diseases: B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma\n\nExclusion Criteria for children:\n\n* Subjects must not be receiving any investigational or additional anti-cancer medicines during induction.\n* Significant concurrent disease, illness, or psychiatric disorder or social issue that would compromise subject safety or adherence to the protocol treatment or procedures, interfere with consent, study participation, follow-up, or interpretation of the study results.\n\nOptional caregiver participation:\n\nInclusion Criteria :All caregivers must meet the following criteria\n\n* Written informed consent to participate in the caregiver interviews.\n* The caregiver must be a parent or legal guardian ≥ 18 years old, and their child must be \\\u003C18 years","6 Years",{"count":80,"type":22},[58],"Acute lymphoblastic leukemia (ALL) is the most common cancer in children and, along with lymphoblastic lymphoma, represents the most common group of childhood lymphoid malignancies. Survival rates have improved over the years, but many children still experience long-term side effects from treatment. These can include tiredness, weak muscles, pain, nerve problems, difficulty moving, and other physical challenges. Many children with ALL are also overweight at diagnosis, and weight gain often continues during treatment. As a result, about half of childhood leukemia survivors have a BMI at or above the 85th percentile.\n\nTreatment decisions are usually based on a child's symptoms and genetic risk factors. However, some risk factors such as physical activity can be modified. Exercise during treatment may help children feel better and may even improve survival. However, research on early symptom tracking and structured exercise during the first phase of chemotherapy is limited, uses different methods, and often does not include reliable patient-reported symptoms.\n\nEffective exercise programs for children with ALL and lymphoblastic lymphoma need to consider the child's age, treatment side effects, motivation, family support, and ways to encourage long-term behavior change. Because children spend little time in the hospital during the induction phase, a mix of in-person and virtual sessions supported by real-time Zoom instruction can make it possible to offer safe and supervised exercise at home.\n\nThis study will use a guided exercise plan that includes tools to track sets, repetitions, intensity, warm-up time, and perceived exertion. These tools help with consistent monitoring and support both patients and caregivers throughout the program. Twenty children newly diagnosed with ALL or lymphoblastic lymphoma who receive standard 3-4 drug induction chemotherapy will be invited to participate. Our goal is to determine whether a 9-week hybrid exercise program, combined with weekly symptom check-ins, is practical and achievable in both hospital and home settings.",[193,496,497,498,29],"Acute Leukemia","Acute Lymphoid Leukemia","Lymphoblastic Lymphoma",[500,501,502,503,504,505,506],"children","pediatric","weight gain","body mass index (BMI)","physical activity","Exercise","hybrid exercise program","2026-07-31",{"date":475,"type":37},{"date":510,"type":37},"2026-05-01",{"date":512,"type":22},"2028-06-01",{"name":514,"class":97},"UNC Lineberger Comprehensive Cancer Center",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":4,"eligibilityCriteria":521,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":23,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":45},"100615695","phase-1-a-study-of-14c-bleximenib-radiolabeled-in-participants-with-acute-leukemia-100615695","NCT07295951","A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia","An Open-Label Study to Investigate the Absorption, Metabolism, And Excretion (AME) Of 14C-Bleximenib (JNJ-75276617) in Participants With Acute Leukemia","Inclusion criteria:\n\n* Body weight greater than or equal to (\\>=) 40 kilograms (kg)\n* Relapsed or refractory (R\u002FR) acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 (NPM1), nucleoporin 98 (NUP98) or nucleoporin 214 (NUP214) gene alterations, and has exhausted, or is ineligible for available therapeutic options\n* Eastern cooperative oncology group (ECOG) performance status grade of 0 or 1\n* Regular bowel movements (that is \\[i.e.\\], average production of at least one stool every 2 days)\n* A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment\n\nExclusion criteria:\n\n* Acute promyelocytic leukemia or diagnosis of Down syndrome associated leukemia, according to world health organization (WHO) 2016 criteria\n* Active central nervous system (CNS) disease\n* Recipient of solid organ transplant\n* Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to Grade 1 or less\n* Major surgery (e.g., requiring general anesthesia) within 2 weeks prior to first dose of study treatment or has not recovered from surgery or has major surgery planned during the time the participant is receiving study treatment",{"count":107,"type":22},[25],"The purpose of this study is to assess how the body absorbs, breaks down (metabolism), and removes (excretes) radiolabeled bleximenib (a drug molecule that has been chemically bonded with a radioactive isotope which emits radiation making it easier to track in the body) in participants with acute leukemia (highly aggressive blood cancer typically characterized by large numbers of immature white blood cells in the bone marrow).",[29,526,162],"Acute Leukemias","2026-07-30",{"date":507,"type":37},{"date":530,"type":37},"2025-11-18",{"date":532,"type":22},"2026-09-29",{"name":534,"class":139},"Janssen Research & Development, LLC",{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":542,"enrollmentInfo":543,"targetDuration":4,"studyType":23,"phases":545,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":548,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":45},"100538216","phase-1-225ac-dota-anti-cd38-daratumumab-monoclonal-antibody-with-fludarabine-melphalan-and-total-marrow-and-lymphoid-irradiation-as-conditioning-treatment-for-donor-stem-cell-transplant-in-patients-with-high-risk-acute-myeloid-leukemia-acute-lymphoblastic-leukemia-and-myelodysplastic-syndrome-100538216","NCT06287944","225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome","Phase I Study of Escalating Doses of 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody Added to the Conditioning Regimen of Fludarabine, Melphalan and Organ Sparing Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* ≥ 70 years. Note: Patients ≥ 18 years and \\\u003C 70 years with active, relapsed or refractory, or high-risk acute leukemia or MDS as defined below.\n* Karnofsky performance status ≥ 70\n* Eligible patients will have a histopathological confirmed diagnosis of hematologic malignancy in one of the following categories :\n\n  * Acute myelogenous leukemia:\n\n    * Patients with de novo or secondary disease in unfavorable risk group including poor risk cytogenetics according to National Comprehensive Cancer Network (NCCN) guidelines for AML i.e., monosomal karyotype, -5,5q-,-7,7q-,11q23-non t(9;11), inv (3), t(3;3), t(6;9), t(9;22) and complex karyotypes (≥ 3 unrelated abnormalities), or all patient in intermediate risk groups accept patients with FLT3-NPM1+ disease, OR\n    * Patients with a complete morphological remission (CR) with minimal residual disease (MRD)-positive status by flow cytometry (≥ 0.1% by flow cytometry) or cytogenetic after at least 2 prior induction therapies, OR\n    * Patients with chemosensitive active disease defined as at least 50% reduction in their blast count after last treatment\n  * Myelodysplastic syndrome in high-intermediate (int-2) and high-risk categories per Revised International Prognostic Scoring System- (IPSS-R)\n  * Acute lymphocytic leukemia\n* Evidence of CD38 expression by flow cytometry AND one of the below\n\n  * Patients with de novo or secondary disease according to NCCN guidelines for ALL hypoploidy (\\\u003C 44 chromosomes); t(v;11q23): MLL rearranged; t(9;22) (q34;q11.2); complex cytogenetics (5 or more chromosomal abnormalities); high white blood cell (WBC) at diagnosis (≥ 30,000 for B lineage or ≥ 50,000 for T lineage); iAMP21loss of 13q, and abnormal 17p, OR\n  * Patients with a complete response (CR) with MRD-positive status by flow cytometry (≥ 0.1% by flow cytometry) or cytogenetics after at least 2 prior induction therapies, OR\n  * Patients with chemosensitive active disease defined as at least 25% reduction in their blast count after last treatment\n  * Patients with myelofibrosis (primary or secondary, including post-polycythemia vera and post-essential thrombocythemia myelofibrosis) may be eligible for enrollment if they meet criteria for high-risk disease and are planned for allogeneic hematopoietic cell transplantation.\n* Eligible patients include those with:\n\n  * Accelerated-phase or blast-phase myelofibrosis, defined as 10% to 19% blasts or ≥20% blasts, respectively, in peripheral blood or bone marrow\n  * High-risk chronic-phase primary or secondary myelofibrosis, defined as disease meeting transplant-appropriate risk criteria by a validated MF prognostic model, including DIPSS intermediate-2 or high-risk; DIPSS-plus intermediate-2 or high-risk; MIPSS70 intermediate, high, or very high-risk; MIPSS70-plus or MIPSS70-plus version 2.0 intermediate, high, or very high-risk; GIPSS intermediate-2 or high-risk; or MYSEC-PM intermediate-2 or high-risk for post-polycythemia vera or post-essential thrombocythemia myelofibrosis. Patients may also qualify based on adverse clinical, cytogenetic, or molecular features supporting high-risk disease biology and transplant candidacy, including complex karyotype, monosomal karyotype, very high-risk karyotype, high molecular risk mutations, transfusion-dependent anemia, thrombocytopenia, circulating blasts, constitutional symptoms, or symptomatic splenomegaly despite standard therapy\n  * Suboptimal response, progression, or intolerance to prior JAK inhibitor therapy, defined as failure to achieve adequate spleen or symptom response after an appropriate trial of therapy, generally at least 12 weeks at an appropriate or maximally tolerated dose when clinically feasible; loss of prior spleen or symptom response; worsening splenomegaly; persistent or worsening constitutional symptoms attributable to MF; worsening cytopenias or transfusion dependence; progression to accelerated-phase or blast-phase disease; emergence of adverse cytogenetic or molecular features; or inability to continue JAK inhibitor therapy due to treatment-related toxicity. A minimum duration of JAK inhibitor exposure is not required when the treating investigator determines that continued therapy is not clinically appropriate due to rapidly progressive disease, accelerated-phase or blast-phase transformation, clinically significant cytopenias, intolerance, or urgent need to proceed to allogeneic HCT. The rationale for early determination of JAK inhibitor failure or inability to continue JAK inhibitor therapy will be documented in the medical record.\n  * Persistent disease burden, including persistent splenomegaly, circulating or marrow blasts, transfusion dependence, cytopenias attributable to MF, leukocytosis, thrombocytopenia, adverse cytogenetic or molecular features, extramedullary hematopoiesis, or progression despite standard therapy, may support high-risk classification but does not constitute a separate eligibility criterion unless the patient also meets the defined advanced-phase, validated risk-model, or JAK inhibitor failure criteria above.\n\n    \\*\\*See Appendix F: Defined Risk Scoring Systems in MF\n  * All patients must demonstrate CD38 expression on disease-relevant cell populations (bone marrow and\u002For peripheral blood) as assessed by flow cytometry or an equivalent validated assay prior to enrollment.\n\nClinical Laboratory and Organ Function Criteria (To be performed within 30 days prior to Day 1 of protocol therapy unless otherwise stated) or (acceptable windows for tests are indicated in the Study Calendar Section 10.0).\n\n* A pretreatment measured creatinine clearance (absolute value) of ≥ 60 ml\u002Fminute (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Patients must have a serum bilirubin ≤ 2.0 mg\u002Fdl (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Patients must have a serum glutamic oxaloacetic transaminase (SGOT) ≤ 2.5 times the institutional upper limits of normal (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Patients must have a serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times the institutional upper limits of normal (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Ejection fraction measured by echocardiogram or multigated acquisition scan (MUGA) ≥ 50% (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Diffusion capacity of the lung for carbon monoxide (DLCO) \\> 50% predicted (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Forced expiratory volume in 1 second (FEV1) \\> 50% predicted (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated)\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n* DONOR SPECIFIC CRITERIA: All candidates for this study must have an human leukocyte antigen (HLA) (A, B, C, and DR) identical sibling who is willing to donate mobilized peripheral blood stem cells (preferred) or bone marrow, or have a 10\u002F10 (A, B, C, DR and DQ) allele matched unrelated donor. DQ or DP mismatch is allowed per discretion of the principal investigator. City of Hope (COH) standards of practice (SOP) (B.001.11) will be used for allogeneic donor evaluation, selection, and consent. Donor screening will be in compliance with all requirements of Food and Drug Administration (FDA) regulation 21 CFR Part 1271 including donor screening for COVID-19 exposure or infection\n\nExclusion Criteria:\n\n* Patients who had a prior allogeneic transplant\n* Patients who have had prior radiotherapy\n* Patients who have received prior radiopharmaceutical therapy\n* Receiving any other investigational agents or concurrent biological, intensive chemotherapy or radiation therapy for the previous 2 weeks from conditioning\n* Patients should have discontinued all previous intensive therapy, chemotherapy, or radiotherapy for 2 weeks prior to commencing therapy on this study. Note: Low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted. These include hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors (TKIs). FLT-3 inhibitors can also be given up to 3 days before conditioning regimen\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Patients with other active malignancies are ineligible for this study, other than non-melanoma skin cancers\n* Patients should not have any uncontrolled illness including ongoing or active bacterial, viral or fungal infection\n* The recipient has a medical problem or neurologic\u002Fpsychiatric dysfunction which would impair his\u002Fher ability to be compliant with the medical regimen and to tolerate transplantation or would prolong hematologic recovery which in the opinion of the investigator (treating physician) would place the recipient at unacceptable risk\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","70 Years",{"count":544,"type":22},15,[25],"This phase I trial tests the safety, side effects, best dose, and effectiveness of 225Ac-DOTA-Anti-CD38 daratumumab monoclonal antibody in combination with fludarabine, melphalan and total marrow and lymphoid irradiation (TMLI) as conditioning treatment for donor stem cell transplant in patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Radioimmunotherapy is treatment with a radioactive substance that is linked to a monoclonal antibody, such as daratumumab, that will find and attach to cancer cells. Radiation given off by the radioisotope my help kill the cancer cells. Chemotherapy drugs, such as fludarabine and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TMLI is a targeted form of body radiation that targets marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize therapy effect. Actinium Ac 225-DOTA-daratumumab combined with fludarabine, melphalan and TMLI may be safe, tolerable, and\u002For effective as conditioning treatment for donor stem cell transplant in patients with high-risk AML, ALL, and MDS.",[29,162,284],{"date":507,"type":37},{"date":550,"type":37},"2025-07-01",{"date":552,"type":22},"2028-05-19",{"name":554,"class":97},"City of Hope Medical Center",{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":17,"minAge":341,"maxAge":562,"enrollmentInfo":563,"targetDuration":4,"studyType":23,"phases":565,"briefSummary":566,"conditions":567,"keywords":576,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":45},"100473255","phase-1-cd19cd22-bicistronic-chimeric-antigen-receptor-car-t-cells-in-children-and-young-adults-with-recurrent-or-refractory-b-cell-malignancies-100473255","NCT05442515","CD19\u002FCD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies","Phase 1\u002F2 Dose Escalation Study of CD19\u002FCD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies","* INCLUSION CRITERIA:\n* Diagnosis\n\n  * Participant must:\n\n    * Have pathology confirmed B cell ALL (not isolated to the testis or CNS), CML with ALL transformation, or high-grade lymphoma (e.g., Burkitt's lymphoma, B-lymphoblastic lymphoma, diffuse large B-cell lymphoma, inclusive of low-grade lymphoma that has transformed to high grade disease); and\n    * Have relapsed or been refractory after at least one standard chemotherapy regimen and at least one salvage treatment. Participants with Philadelphia chromosome + ALL must have failed prior tyrosine kinase inhibitor; and\n    * Be ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have recurred after SCT; and\n    * Be unable to access (in a timely manner), ineligible for, or have relapsed\u002Ffailed after or not responded to a commercially available CD19 CAR T-cell construct; and\n  * Have evidence of at least minimal residual disease or PET-avid disease (lymphoma) at the time of enrollment.\n* CD22\u002FCD19 expression\n\n  * Cohorts A1b, B1b, C2b\n\n    * CD19 must be detected on \\>15% of the malignant cells by immunohistochemistry or \\> 80% by flow cytometry.\n    * CD22 positivity must be confirmed.\n  * Cohorts D1b, 2 B-ALL\n\n    * CD19 or CD22 positivity must be confirmed\n    * Age \\>= 3 years of age and \\\u003C=39 years of age at time of enrollment.\n    * Clinical Performance status: Participants \\>= 16 years of age: Karnofsky \\>= 50%; Participants \\\u003C 16 years of age: Lansky scale \\>= 50%.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>= 750\u002FmcL\\*\n  * platelets \\>= 50,000\u002FmcL\\*\n  * total bilirubin \\\u003C=2 X ULN (except in the case of participants with documented Gilbert's disease \\> 3x ULN)\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C=10 X institutional upper limit of normal\n  * creatinine \\\u003C= the maximum for age listed in the table below OR\n  * measured creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above the max listed below per age.\n\n    * Age (Years) \\\u003C= 5 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 0.8\n    * Age (Years) 6 to \\\u003C= 10 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 1.0\n    * Age (Years) \\>10 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 1.2\n\n      * a participant will not be excluded because of pancytopenia \\>= Grade 3 if it is due to underlying bone marrow involvement by leukemia\n* Central nervous system (CNS) Status\n* Participants with leukemia with CNS 1 and 2 disease are eligible in the absence of exclusion criteria\n* Participants of child-bearing or child-fathering potential must be willing to practice effective birth control from the time of enrollment until 12 months following completion of study treatment for women and for 4 months following completion of study treatment for men.\n* Participants who are breastfeeding or plan to breastfeed must agree to discontinue\u002Fpostpone breastfeeding while on study therapy and until 1 month after the administration of CAR.\n* Cardiac function: Left ventricular ejection fraction \\>= 45% or fractional shortening \\>=28%\n* Pulmonary Function\n\n  * Baseline oxygen saturation \\>92% on room air at rest\n* Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n* Ability and willingness of participant or Legally Authorized Representative (LAR) to co- enroll on 15-C-0028: Follow-up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials.\n\nEXCLUSION CRITERIA:\n\nParticipants meeting any of the following criteria are not eligible for participation in the study:\n\n* Participants with CNS3 disease, progressing neurologic signs\\* of CNS disease, radiologically detected active CNS lymphoma (\\*resolving manifestation or persistent and\u002For irreversible findings from prior CNS involvement (e.g., blindness) is not exclusionary)\n* Hyperleukocytosis (\\>= 50,000 blasts\u002FmicroL)\n* Positive serum or urine beta-HCG pregnancy test performed at screening.\n* Participants will be excluded based on prior therapy if they fail to meet following washout criteria:\n\n  * Therapy: Systemic Chemotherapy, anti-neoplastic agents, antibody- based therapies\n  * Washout\\*: \\>=2 weeks\n  * Exceptions: 6 weeks for clofarabine or nitrosoureas; No washout for prior intrathecal chemotherapy, steroid therapy, hydroxyurea (no dose increases within prior 2 weeks) or ALL maintenance-type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate, or a tyrosine kinase inhibitor for participants with Ph+ ALL) provided there is recovery from any acute toxic effects\n  * Therapy: Radiation\n  * Washout\\*: \\>=3 weeks\n  * Exceptions: No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the participant has measurable\u002Fevaluable disease outside the radiation window\n  * Therapy: Allogeneic Stem Cell Transplant\n  * Washout\\*: \\>= 100 days since SCT; \\>= 30 days since completion of immunosuppression; \\>= 6 weeks since donor lymphocyte infusion (DLI)\n  * Exceptions: Cannot have evidence of active graft-versus-host disease (GVHD) requiring systemic immunosuppression\n  * Therapy: CAR T-Cell Therapy or other Adoptive Cell Therapy\n  * Washout\\*: \\> 30 days post infusion\n\n    * Washout: Time between therapy and apheresis\n* Positive HIV antibodies consistent with active HIV.\n* Positive hepatitis C antibodies or positive Hepatitis B surface antigen (HbsAG) indicative of current\u002Factive HCV\u002FHBV.\n* Active second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and participant is in remission.\n* History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells.\n* Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the participant.","39 Years",{"count":564,"type":22},130,[25,82],"Background:\n\nAcute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses.\n\nObjective:\n\nTo test chimeric antigen receptor (CAR) therapy. CARs are genetically modified cells created from each patient s own blood cells. his trial will use a new type of CAR T-cell that is targeting both CD19 and CD22 at the same time. CD19 and CD22 are proteins found on the surface of most types of ALL.\n\nEligibility:\n\nPeople aged 3 to 39 with ALL or related B-cell lymphoma that has not been cured by standard therapy.\n\nDesign:\n\nParticipants will be screened. This will include:\n\nPhysical exam\n\nBlood and urine tests\n\nTests of their lung and heart function\n\nImaging scans\n\nBone marrow biopsy. A large needle will be inserted into the body to draw some tissues from the interior of a bone.\n\nLumbar puncture. A needle will be inserted into the lower back to draw fluid from the area around the spinal cord.\n\nParticipants will undergo apheresis. Their blood will circulate through a machine that separates blood into different parts. The portion containing T cells will be collected; the remaining cells and fluids will be returned to the body. The T cells will be changed in a laboratory to make them better at fighting cancer cells.\n\nParticipants will receive chemotherapy starting 4 or 5 days before the CAR treatment.\n\nParticipants will be admitted to the hospital. Their own modified T cells will be returned to their body.\n\nParticipants will visit the clinic 2 times a week for 28 days after treatment. Follow-up will continue for 15 years....",[568,569,570,29,571,28,572,573,574,575,497],"B-NHL","B-Non Hodgkin Lymphoma","Acute Lymphocytic Leukemia","B-precursor ALL","Lymphoma, Non-Hodgkin","Leukemia, Lymphocytic, B Cell","B-Cell Lymphoma","B-Cell Leukemia",[577,285,578,579,31,28,571,29,570,569],"Philadelphia chromosome + ALL","CD-22 Expressing Tumor","CD-19 expressing tumor","2026-07-29",{"date":527,"type":37},{"date":583,"type":37},"2022-12-28",{"date":585,"type":22},"2029-07-01",{"name":43,"class":44},{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":17,"minAge":471,"maxAge":593,"enrollmentInfo":594,"targetDuration":4,"studyType":23,"phases":595,"briefSummary":596,"conditions":597,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":45},"100264904","phase-2-personalized-nk-cell-therapy-in-cbt-100264904","NCT02727803","Personalized NK Cell Therapy in CBT","Inclusion Criteria:\n\n* Patients must have one of the following hematologic malignancies: acute myelogenous leukemia (AML), induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics including complex karyotype, abnormal \\[abn\\]\\[3q\\], -5\u002F5q-, -7\u002F7q-, abn\\[12p\\], abn\\[17p\\], myeloid\u002Flymphoid or mixed-lineage leukemia \\[MLL\\] gene re-arrangement and t \\[6;9\\]47, fms related tyrosine kinase 3 \\[flt3\\] mutation positive and\u002For evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and\u002For arising from myelodysplastic syndromes (MDS), any disease beyond first remission\n* Myelodysplastic syndrome (MDS): Primary or therapy related, including patients that will be considered for transplant; these include any of the following categories: 1) revised International Prognostic Scoring System (IPSS) intermediate and high risk groups, 2) malondialdehyde (MDA) with transfusion dependency, 3) failure to respond or progression of disease on hypomethylating agents, 4) refractory anemia with excess of blasts, 5) transformation to acute leukemia, 6) chronic myelomonocytic leukemia, 7) atypical MDS\u002Fmyeloproliferative syndromes, 8) complex karyotype, abn(3g), -5\u002F5g-, -7\u002F7g-, abn(12p), abn(17p)\n* Acute lymphoblastic leukemia (ALL): Induction failure, primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease; patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time: with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure, and\u002For evidence of minimal residual disease or acute biphenotypic leukemia, or double hit non-Hodgkin's lymphoma\n* Non-Hodgkin's lymphoma (NHL) in second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant); relapsed double hit lymphomas; patients with options for treatment that are known to be curative are not eligible\n* Small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL) with progressive disease following a minimum of two lines of standard therapy\n* Chronic myeloid leukemia (CML) second chronic phase or accelerated phase\n* Hodgkin's disease (HD): Induction failures, after first complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant), or those with active disease\n* Multiple myeloma: stage II or III, symptomatic, secretory multiple myeloma requiring treatment\n* A person (such as a haploidentical family member) or unit of cord blood must be identified as a source of back-up cells source in case of engraftment failure\n* Patient age criteria: age \\>= 15 and =\\\u003C 45 years (myeloablative regimen 1; age \\>= 15 and =\\\u003C 80 years (nonmyeloablative regimen 2) at the discretion of the investigator(s); age \\>= 15 and =\\\u003C 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy may receive reduced intensity regimen 3\n* Performance score of at least 60% by Karnofsky\n* Left ventricular ejection fraction of at least 40% (myeloablative regimen 1, reduced intensity regimen 3)\n* Left ventricular ejection fraction of at least 30% (nonmyeloablative regimen 2)\n* Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least 50% predicted value for hemoglobin concentration (myeloablative regimen 1, reduced intensity regimen 3)\n* Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or glomerular filtration rate \\[GFR\\]) \\> 40mL\u002Fmin\u002F1.73 m\\^2\n* Serum glutamate pyruvate transaminase (SGPT)\u002Fbilirubin \\\u003C to 2.0 x normal (myeloablative regimen 1), reduced intensity regimen 3; SGPT\u002Fbilirubin \\\u003C to 4.0 x normal (nonmyeloablative regimen 2)\n* Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months\n* Patients with options for treatment that are known to be curative are not eligible\n* Patients enrolled in this study may be enrolled on other supportive care investigational new drug (IND) studies at the discretion of the principal investigator (PI)\n\nExclusion Criteria:\n\n* Human immunodeficiency virus (HIV) positive; HIV results will be determined by nucleic acid testing\n* Uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation (excluding primary disease for which cord blood \\[CB\\] transplantation is proposed), or psychiatric condition that would limit informed consent\n* Active central nervous system (CNS) disease in patient with history of CNS malignancy\n* Availability of appropriate, willing, human leukocyte antigen (HLA)-matched related stem cell donor","80 Years",{"count":212,"type":22},[82],"This phase II clinical trial studies how well personalized natural killer (NK) cell therapy works after chemotherapy and umbilical cord blood transplant in treating patients with myelodysplastic syndrome, leukemia, lymphoma or multiple myeloma. This clinical trial will test cord blood (CB) selection for human leukocyte antigen (HLA)-C1\u002Fx recipients based on HLA-killer-cell immunoglobulin-like receptor (KIR) typing, and adoptive therapy with CB-derived NK cells for HLA-C2\u002FC2 patients. Natural killer cells may kill tumor cells that remain in the body after chemotherapy treatment and lessen the risk of graft versus host disease after cord blood transplant.",[598,599,29,600,601,602,603,604,605,606,607,608,609,284,610,611,612,613,614,615,616,617,618,619,620,621],"Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Acute Biphenotypic Leukemia","Acute Lymphoblastic Leukemia in Remission","Acute Myeloid Leukemia With Myelodysplasia-Related Changes","Acute Myeloid Leukemia With Variant MLL Translocations","B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","Chemotherapy-Related Leukemia","Chronic Myelomonocytic Leukemia","Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","ISS Stage II Plasma Cell Myeloma","ISS Stage III Plasma Cell Myeloma","Myelodysplastic Syndrome With Excess Blasts","Myelodysplastic Syndrome With Gene Mutation","Myelodysplastic\u002FMyeloproliferative Neoplasm","Previously Treated Myelodysplastic Syndrome","Recurrent Acute Myeloid Leukemia","Recurrent Adult Acute Myeloid Leukemia","Recurrent Hodgkin Lymphoma","Recurrent Non-Hodgkin Lymphoma","Refractory Acute Lymphoblastic Leukemia","Refractory Adult Acute Lymphoblastic Leukemia","Secondary Acute Myeloid Leukemia","Therapy-Related Myelodysplastic Syndrome","2026-07-28",{"date":527,"type":37},{"date":625,"type":37},"2016-05-19",{"date":627,"type":22},"2027-05-31",{"name":250,"class":97},{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":258,"sex":17,"minAge":18,"maxAge":278,"enrollmentInfo":636,"targetDuration":4,"studyType":23,"phases":638,"briefSummary":639,"conditions":640,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":654,"locationsCount":655},"100594521","phase-1-a-vaccine-cmv-mva-triplex-vaccine-for-the-enhancement-of-cmv-specific-immunity-and-the-prevention-of-cmv-viremia-in-patients-undergoing-haploidentical-hematopoietic-stem-cell-transplant-100594521","NCT07020533","A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant","A Phase 1b Trial of CMV-MVA Triplex Vaccine in Haploidentical Stem Cell Donors and Recipients to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients of Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n* DONORS: Documented informed consent of the participant. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* DONORS: Age: 18 - 75.\n* DONORS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* DONORS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and for up to 90 days post-vaccination.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n* RECIPIENTS: Documented informed consent of the participant and\u002For legally authorized representative. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* RECIPIENTS: Participant must be willing to comply with study and\u002For follow-up procedures, including willingness to be followed for one year post-HCT.\n* RECIPIENTS: Age: 18 - 75.\n* RECIPIENTS: Planned peripheral blood stem cell (PBSC) or bone marrow (BM) HCT for the treatment of the following hematologic malignancies:\n\n  * Lymphoma (Hodgkin and Non-Hodgkin).\n  * Myelodysplastic syndrome.\n  * Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia\u002Flymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood. Persistent lymphadenopathy on computed tomography (CT) or CT\u002Fpositron emission tomography(PET) scan without progression is allowed.)\n  * Acute myeloid leukemia in first or second remission.\n  * Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase.\n  * Other hematologic malignancies judged appropriate by the clinical principal investigators (PIs), including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis. Patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded\\*\\*.\n\n    * Adult cases of multiple myeloma (MM) are excluded as HCT is not standard of care for MM and is only performed in very advanced cases with an associated high risk of relapse and non-relapse mortality (NRM). Adults with aplastic anemia are excluded because their standard management includes T cell depletion with agents such as antithymocyte globulin (ATG), which is not permissible on this protocol. Patients undergoing a second haploHCT are not eligible (patients who have undergone a previous autologous HCT are eligible).\n* RECIPIENTS: Patients receiving myeloablative (MA) or reduced intensity conditioning (RIC) are allowed.\n* RECIPIENTS: CMV seropositive.\n* RECIPIENTS: Eligible haploidentical donors will have 2-4 mismatches if human leukocyte antigen (HLA)-A, -B, -C, and -DRB1 typing is used; 2-5 mismatches if HLA-A, -B, -C, -DRB1, and -DQB1 typing is used; and 2-6 mismatches if HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1 typing is used. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must demonstrate that they are a full haplotype match by being identical at a minimum of one allele (at high resolution deoxyribonucleic acid \\[DNA\\]-based typing) at the following genetic loci: HLA-A, -B, -C, and DRB1 if 8 allele typing is used; HLA-A, -B, -C, -DRB1, and -DQB1 if 10 allele typing is used; and HLA-A, -B, -C, -DRB1-, DQB1, and -DPB1 is 12 allele typing is used.\n* RECIPIENTS: Planned HCT with minimal to no-T cell depletion of graft.\n* RECIPIENTS: Conditioning and immunosuppressive regimens according to institutional guidelines are permitted.\n* RECIPIENTS: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Estimated creatinine clearance acceptable per institutional guidelines (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Left ventricular ejection fraction (LVEF) ≥ 50%.\n\n  * Note: To be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and carbon monoxide diffusing capability (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin).\n\n  * If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air.\n  * Note to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combination (combo), hepatitis c virus (HCV)\\*, active hepatitis b virus (HBV) (surface antigen negative) and syphilis (RPR) within 2 months of registration and no history of disseminated cutaneous human papillomavirus (HPV) related disease.\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable.\n* RECIPIENTS: Meets other institutional and federal requirements for infectious disease titer requirements.\n\n  * Note Infectious disease testing to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and up to 90 days post-HCT.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nExclusion Criteria:\n\n* DONORS: Any prior transplant to day 1 of protocol therapy (day 1 defined as the day after donors receive the Triplex vaccine).\n* DONORS: Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy.\n* DONORS: Receipt of any vaccine (licensed or investigational) within 30 days prior to and after the study vaccine.\n* DONORS: Unfit to undergo standard stem cell mobilization and apheresis e.g. abnormal blood counts, history of stroke, uncontrolled hypertension.\n* DONORS: Sickling hemoglobinopathy including hemoglobin (Hb)SS, HbAS, HbSC.\n* DONORS: Donors with impaired cardiac function are excluded. Electrocardiography is routine for potential HCT donors over 60 years old and those with a history of heart disease. Subjects in whom cardiac function is abnormal (excluding 1st degree branch block, sinus bradycardia, sinus tachycardia or non-specific T wave changes) are ineligible for Triplex vaccination.\n* DONORS: Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the donation procedure unlikely and making informed consent impossible.\n* DONORS: Females only: Pregnant or breastfeeding.\n* DONORS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* DONORS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).\n* RECIPIENTS: Any prior investigational CMV vaccine.\n* RECIPIENTS: Experimental anti-CMV chemotherapy in the last 6 months.\n* RECIPIENTS: Live attenuated vaccines (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Medically indicated subunit (Engerix-B for HBV; Gardasil for HPV) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Allergy treatment with antigen injections (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Alemtuzumab or any equivalent in vivo T-cell depleting agent (or CD34+ selection) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)\u002Fvalganciclovir (VAL), foscarnet (FOS), cidofovir, CMX-001, maribavir. Acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment EXCEPT letermovir prophylaxis (prior to day 100) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Disease-based radiation therapy (not total body irradiation) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other investigational product(s) - concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other medications that might interfere with the evaluation of the investigational product (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years.\n* RECIPIENTS: Patients considered by PI\u002Fconsenting physicians to have a complicated prior therapy or HCT regimen, or who have a low survival probability (e.g., refractory leukemia and\u002For undergoing 2nd HCT).\n* RECIPIENTS: Poor risk disease\u002Fdisease status including: Chronic myelogenous leukemia (CML) in blast crisis, acute myeloid leukemia (AML)\u002Facute lymphoblastic leukemia (ALL) beyond 2nd remission, multiple myeloma, and aplastic anemia.\n* RECIPIENTS: Females only: Pregnant or breastfeeding.\n* RECIPIENTS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* RECIPIENTS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",{"count":637,"type":22},46,[25],"This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic stem cell transplant. Haploidentical stem cell transplantation (haploHCT) has advanced to become the predominant procedure for patients lacking a matched donor. Compared to matched related donor transplants, the rate of significant CMV infection is higher in patients undergoing a haploHCT. Significant CMV infection is associated with an increased risk of complications and death. Vaccination is the main preventative approach to limit complications and death in immunocompromised patients at high risk of post-stem cell transplant infections. CMV-MVA Triplex vaccine, is a CMV vaccine based on the attenuated poxvirus, modified vaccinia Ankara (MVA), developed to enhance CMV-specific immunity in both healthy stem cell transplant donors and stem cell transplant patients to prevent significant CMV infection post-stem cell transplant. Giving CMV-MVA triplex vaccine may be safe, tolerable and\u002For effective in enhancing cytomegalovirus (CMV)-specific immunity and preventing CMV viremia in patients undergoing a haploHCT.",[641,29,162,287,642,643,644,498,284,645,646,647],"Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Hematopoietic and Lymphatic System Neoplasm","Hodgkin Lymphoma","Myelofibrosis","Myeloproliferative Neoplasm","Non-Hodgkin Lymphoma","2026-07-27",{"date":622,"type":37},{"date":651,"type":37},"2026-05-08",{"date":653,"type":22},"2029-05-30",{"name":554,"class":97},3,{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":4,"eligibilityCriteria":662,"healthyVolunteers":258,"sex":17,"minAge":148,"maxAge":663,"enrollmentInfo":664,"targetDuration":4,"studyType":23,"phases":666,"briefSummary":667,"conditions":668,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":681,"startDateStruct":682,"completionDateStruct":684,"leadSponsor":685,"locationsCount":107},"100345603","phase-2-naive-t-cell-depletion-for-preventing-chronic-graft-versus-host-disease-in-children-and-young-adults-with-blood-cancers-undergoing-donor-stem-cell-transplant-100345603","NCT03779854","Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant","Multi-Center Phase II Randomized Controlled Trial of Naïve T Cell Depletion for Prevention of Chronic Graft-Versus-Host Disease in Children and Young Adults","Inclusion Criteria:\n\n* The patient must have one of the following diagnoses and be considered to be an appropriate candidate for allogeneic HCT by the study site principal investigator (PI):\n\n  * Acute lymphoblastic leukemia (ALL) with \\\u003C 5% marrow blasts.\n  * Acute myeloid leukemia (AML) with \\\u003C 25% marrow blasts.\n  * Other acute leukemia (OAL) or related neoplasm (including but not limited to acute biphenotypic leukemia \\[ABL\\], ambiguous lineage \\[ALAL\\], mixed phenotype acute leukemia \\[MPAL\\], blastic plasmacytoid dendritic cell neoplasm \\[BPDCN\\], acute undifferentiated leukemia \\[AUL\\], lymphoblastic lymphoma, Burkitt leukemia\u002Flymphoma, mast cell leukemia, chronic monocytic leukemia \\[CML\\] with blast crisis or other chronic myeloproliferative neoplasm) with \\\u003C 5% marrow blasts.\n  * Myelodysplastic syndrome (MDS) with excess blasts (EB-1 and EB-2) and has received cytotoxic induction chemotherapy (excluding small molecule inhibitors and de-methylating agents)\n* Age 6 months to 26 years at the time informed consent is obtained using the Informed Consent to Participate in a Research Study form\n* Matched related donor (MRD) or matched unrelated donor (MUD) (defined as 8\u002F8 match for human leukocyte antigen \\[HLA\\]-A, -B, -C, -DRB1).\n* Planned product type for infusion is PBSC or BM (i.e. not cord blood):\n\n  * For feasibility phase, planned product type for infusion must be PBSC.\n  * For RCT, planned product type must be PBSC or BM.\n* Karnofsky or Lansky score \\>= 60%.\n* Left ventricular ejection fraction (LVEF) at rest \\>= 40%.\n* Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for hemoglobin) \\>= 60% predicted by pulmonary function tests (PFTs)\n\n  \\* Patients who are unable to perform PFTs (age \\\u003C 6 years or considered developmentally incapable of PFTs): oxygen saturation (by oximetry) must be \\>= 92% on room air.\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) (unless value\\[s\\] \\> 2 x ULN are disease- or medication-related).\n\n  \\* If value(s) are \\> 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal (GI) physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\\\u003C 2 x ULN (unless value\\[s\\] \\> 2 x ULN are disease- or medication-related).\n\n  \\* If value(s) are \\> 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal GI physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.\n* Serum creatinine (SCr) within normal range for age. If SCr is outside normal range for age, creatinine clearance (CrCl) \\> 40 mL\u002Fmin\u002F1.73m\\^2 must be obtained (measured by 24-hour \\[hr\\] urine specimen or nuclear glomerular filtration rate \\[GFR\\]).\n\n  * Age (Years): Maximum SCr (mg\u002FdL)\n  * =\\\u003C 5: 0.8\n  * 6-10: 1\n  * 11-15: 1.2\n  * \\> 15: 1.5\n* Recipient informed consent\u002Fassent\u002Flegal guardian permission documentation must be obtained.\n* DONOR: May be related (MRD) or unrelated (MUD) to the subject.\n* DONOR: Must be matched to the subject at 8\u002F8 HLA alleles (HLA-A, -B, -C, and -DRB1)\n* DONOR: Be \\>=14 years of age.\n* DONOR: Must be available to donate in the United States of America (USA) (i.e. excludes international donors).\n* DONOR: Must agree to donate BM or PBSC (i.e. agree to donate whichever product type is requested) (applicable only to the RCT phase of this study).\n* DONOR: MUDs:\n\n  * Must give informed consent according to applicable National Marrow Donor Program (NMDP) donor regulatory requirements\n  * Must meet eligibility criteria as defined by the NMDP or be ineligible with statement of urgent medical need (exception 21 CFR 1271.65(b)(iii))\n\n    * Tests must be performed using Food and Drug Administration (FDA) licensed, cleared, and approved test kits in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory\n* DONOR: MRDs:\n\n  * Must be negative for human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2, hepatitis B, hepatitis C (serological and\u002For nucleic acid testing \\[NAT\\] and\u002For other approved testing)\n  * Must meet institutional donor eligibility criteria, or be ineligible with statement that the donor is a first or second degree relative (exception 21 CRF 1271.65(b)(i)).\n\n    * Tests must be performed using FDA licensed, cleared, and approved test kits in a CLIA-certified laboratory.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease. A patient may have a history of CNS disease; however, any CNS disease must be cleared by the end of the pre-conditioning evaluation. If CNS disease is identified on the first cerebrospinal fluid (CSF) evaluation within 30 days of the start of the preparative regimen, a repeat CSF evaluation must be performed and show no evidence of disease in order for the patient to be eligible for the protocol.\n* Patients on other experimental protocols for the prevention of GVHD.\n* Patient body weight:\n\n  * Matched related donor (MRD): \\> 100 kg are ineligible\n  * Matched unrelated donor (MUD): \\> 75 kg must be discussed with the protocol principal investigator (PI) prior to enrollment.\n* HIV-positive.\n* Uncontrolled infections must be evaluated by an infectious disease physician and considered suitable to undergo HCT by the study site PI, infectious disease physician and protocol PI. Upper respiratory tract infection (URI) does not constitute an uncontrolled infection in this context.\n* Life expectancy \\\u003C 3 months from disease other than acute leukemia or myelodysplastic syndrome (MDS).\n* Significant medical condition that would make recipient unsuitable for HCT.\n* Prior allogeneic or autologous HCT.\n* Females who are pregnant or breastfeeding.\n* Patients of child bearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during study treatment and for 12 months following HCT.\n* Known hypersensitivity to tacrolimus, fludarabine, or methotrexate (MTX).","26 Years",{"count":665,"type":22},68,[82],"This phase II trial studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body's normal tissues (called graft versus host disease). Removing a particular type of T cell (naive T cells) from the donor cells before the transplant may stop this from happening.",[599,496,669,29,670,671,672,673,674,675,676,677,678,679,498,680,646],"Acute Leukemia of Ambiguous Lineage","Acute Undifferentiated Leukemia","Allogeneic Hematopoietic Stem Cell Transplantation Recipient","Blastic Plasmacytoid Dendritic Cell Neoplasm","Blasts Under 25 Percent of Bone Marrow Nucleated Cells","Blasts Under 5 Percent of Bone Marrow Nucleated Cells","Mixed Phenotype Acute Leukemia","Myelodysplastic Syndrome With Excess Blasts-1","Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Burkitt Leukemia","Chronic Monocytic Leukemia","Mast Cell Leukemia",{"date":580,"type":37},{"date":683,"type":37},"2019-08-29",{"date":136,"type":22},{"name":686,"class":97},"Fred Hutchinson Cancer Center",{"id":688,"slug":689,"hasResults":12,"nctId":690,"briefTitle":691,"officialTitle":692,"acronym":4,"eligibilityCriteria":693,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":149,"enrollmentInfo":694,"targetDuration":4,"studyType":23,"phases":696,"briefSummary":697,"conditions":698,"keywords":703,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":707,"lastUpdatePostDateStruct":708,"startDateStruct":710,"completionDateStruct":712,"leadSponsor":714,"locationsCount":716},"100357464","phase-1-safety-and-efficacy-of-ponatinib-for-treatment-of-pediatric-recurrent-or-refractory-leukemias-lymphomas-or-solid-tumors-100357464","NCT03934372","Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors","An Open-Label, Single-Arm, Phase 1\u002F2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors in Pediatric Participants","Inclusion Criteria:\n\nHistologically or cytologically confirmed diagnosis of the following malignancies:\n\n\\- Phase 1: CP-CML, BP-CML, AP-CML ALL. AML. Other leukemias. Lymphoma. Any other tumors, including tumors of the CNS, for which standard therapy is not available or is not indicated.\n\n\\- Phase 2, Group A with CP-CML: CP-CML at the time of study entry and must be resistant to or intolerant of at least 1 prior BCR-ABL-targeted TKI therapy or be in \"warning\" response status or have the T315I kinase domain mutation.\n\nMust have 1 bone marrow aspirate with documentation of BCR-ABL translocation by conventional cytogenetics, metaphase FISH, or q-PCR performed within 42 days before the first dose of ponatinib.\n\n\\- Phase 2, Group B with other leukemias or solid tumors: ALL. AML. Other leukemias. Lymphoma. Any other tumors, including tumors of the CNS, with mutations of RET, FLT3, KIT, FGFR, PDGFR, TIE2, VEGFR, or any other mutations where ponatinib may have biological activity (eg, EPH receptors and SRC families of kinases) as assessed on fresh or archived tumor tissue.\n\nParticipants with solid tumors or with lymphoma must have measurable disease by CT or MRI based on RECIST v1.1 or the Lugano lymphoma guidelines as determined by site radiology.\n\nPrior therapies as follows:\n\n\\- Phase 1: Participants with CML who are resistant to or intolerant of (as defined Appendix F) to at least 1 prior BCR-ABL-targeted TKI therapy.\n\nParticipants with ALL who have progressed on or after all available or indicated therapies, which may have included 1 prior BCR-ABL-targeted TKI therapy.\n\nParticipants with AML or other leukemias who have progressed on or after at least 1 prior induction attempt (for France only) or for whom no effective standard therapy is available or indicated (other countries).\n\nParticipants with solid tumors (including tumors of the CNS) or lymphomas who have progressed despite standard therapy or for whom no effective standard therapy is available or indicated.\n\n\\- Phase 2, Group A with CP-CML: Participants who are resistant to or intolerant of at least 1 prior BCR-ABL-targeted TKI therapy.\n\n\\- Phase 2, Group B with other leukemias or solid tumors: Participants with ALL who have progressed on or after all available or indicated therapies, which must have included 1 prior BCR-ABL-targeted TKI therapy.\n\nParticipants with AML or other leukemias who have progressed on or after at least 1 prior induction attempt (for France only) or for whom no effective standard therapy is available or indicated (other countries).\n\nParticipants with solid tumors (including tumors of the CNS) or lymphomas who progressed despite standard therapy or for whom no effective standard therapy is available or indicated.\n\n* Karnofsky performance status ≥ 40% for participants ≥ 16 years old or Lansky Play Scale ≥ 40% for pediatric participants \\\u003C 16 years old.\n* Participants must have recovered to \\\u003C Grade 2 per the NCI CTCAE v5.0 or to baseline from any non-hematologic toxicities (except alopecia) due to previous therapy.\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\nPrior therapies:\n\n\\- Participants with BP-CML, ALL, or AML who have received any of the following: Corticosteroids or hydroxyurea within 24 hours before the first dose of ponatinib.\n\nVincristine within 7 days before the first dose of ponatinib. Other chemotherapy (excluding intrathecal chemotherapy) within 14 days before the first dose of ponatinib.\n\n\\- Participants (except the BP-CML, ALL, and AML participants described above) who: Have had cytotoxic chemotherapy within 21 days (or 42 days for nitrosoureas or mitomycin C) before the first dose of ponatinib.\n\nPrior radiation therapy or radio-isotope therapy within 6 weeks before the first dose of ponatinib except local radiotherapy for palliative indication within 14 days before the first dose of ponatinib.\n\nAutologous or allogeneic stem cell transplant \\\u003C 3 months before the first dose of ponatinib.\n\nMajor surgery within 14 days before the first dose of ponatinib. Inadequate recovery and\u002For complications from a major surgery before starting therapy.\n\nPrior treatment with any of the following:\n\n* Immunosuppressive therapy (including post stem cell transplant regimens) within 14 days before the first dose of ponatinib.\n* Any targeted cancer therapy (including TKIs) within 7 days before the first dose of ponatinib.\n* Any other investigational anticancer agents within 30 days or 5 half-lives, whichever is longer, before randomization.\n* Any monoclonal antibody-directed anticancer therapy within 5 half-lives of the first dose of ponatinib.\n* Any chimeric antigen receptor therapy within 28 days before the first dose of ponatinib\n* Ponatinib\n* Protocol-defined lab Values\n* Significant concurrent, uncontrolled medical condition, including but not limited to the following:\n* Pancreatic: clinical, radiological, or laboratory evidence of pancreatitis.\n* Cardiac:\n* SF \\\u003C 27% by ECHO, OR EF \\\u003C 50% by MUGA.\n* Abnormal QTcF on screening ECG, defined as QTcF of ≥ 450 ms.\n* Clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute MI within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV CHF (see Appendix P), and arrhythmia requiring therapy unless approved by the medical monitor\u002Fsponsor.\n* Uncontrolled hypertension.\n* Currently taking drug(s) that are known to have a risk of causing prolonged QTc or TdP unless the drug(s) can be changed to acceptable alternatives (ie, an alternate class of agents that do not affect the cardiac conduction system), or the participant can safely discontinue the drug(s).\n* Cerebral:\n* Participants with solid tumors with intracranial metastasis OR participants with active CNS leukemia (ie, CNS-2 status \\[\\\u003C 5\u002FμL WBCs and cytospin positive for blasts, or ≥ 5 \u002FμL WBCs but negative by Steinherz\u002FBleyer algorithm (equation used for traumatic lumbar punctures), disseminated leptomeningeal disease, or CNS chloroma.\n* Pre-existing significant CNS pathology including history of severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination\u002Fmovement disorder, or autoimmune disease with CNS involvement.\n* History of cerebrovascular ischemia\u002Fhemorrhage with residual deficits.\n* Note: Participants with a history of cerebrovascular ischemia\u002Fhemorrhage remain eligible provided all neurologic deficits have resolved clinically according to Inclusion Criterion 6.\n* Uncontrolled seizure disorder.\n* Coagulation:\n* Significant bleeding disorder or thrombophilia unrelated to the underlying malignancy indication for study participation.\n* Gastrointestinal:\n* Gastrointestinal disorders, such as malabsorption syndrome or any other illness that could affect oral absorption.\n* Genetic:\n* Participants with DNA fragility syndromes, such as Fanconi anemia and Bloom syndrome.\n* Participants with Down syndrome.\n* Participants with any active ≥ Grade 2 graft versus host disease.\n* Chronic or current active uncontrolled infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.\n* Active HBV or HCV infection that requires treatment or at risk for HBV reactivation. Hepatitis B virus DNA and HCV RNA must be undetectable upon testing. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive.\n* Known HIV infection.\n* Current use of prohibited medication (see Section 6.7.2).\n* Known hypersensitivity or severe reaction to ponatinib or excipients of ponatinib.\n* Receipt of live (including attenuated) vaccines or anticipation of need for such vaccines during the study.\n* Inability or unlikeliness to comply with the dose schedule and study evaluations, in the opinion of the investigator.\n* Females who are pregnant or lactating.\n* Other exclusions may apply.",{"count":695,"type":22},70,[25,82],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ponatinib in children aged 1 to \\\u003C 18 years with advanced leukemias, lymphomas, and solid tumors.",[162,699,700,701,29,570,193,285,702],"Accelerated Phase Chronic Myeloid Leukemia","Blast Phase Chronic Myeloid Leukemia","Chronic Phase Chronic Myeloid Leukemia","Solid Tumors",[193,704,168,705,706],"Solid tumors","Tyrosine kinase inhibitor","lymphomas","2026-07-22",{"date":709,"type":37},"2026-07-23",{"date":711,"type":37},"2020-01-29",{"date":713,"type":22},"2028-02-01",{"name":715,"class":139},"Incyte Biosciences International Sàrl",23,{"id":718,"slug":719,"hasResults":12,"nctId":720,"briefTitle":721,"officialTitle":722,"acronym":4,"eligibilityCriteria":723,"healthyVolunteers":12,"sex":17,"minAge":148,"maxAge":724,"enrollmentInfo":725,"targetDuration":4,"studyType":23,"phases":727,"briefSummary":728,"conditions":729,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":731,"lastUpdatePostDateStruct":732,"startDateStruct":733,"completionDateStruct":735,"leadSponsor":737,"locationsCount":45},"100517121","phase-2-cord-blood-transplant-cyclophosphamide-fludarabine-and-total-body-irradiation-in-treating-patients-with-high-risk-hematologic-diseases-100517121","NCT06013423","Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases","Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults and Pediatrics","Inclusion Criteria:\n\n* Patients aged 6 months to =\\\u003C 65 years at time of consent.\n* Acute myelogenous leukemia (AML):\n\n  * Complete first remission (CR1), complete second remission (CR2) or greater (CR2+), must have \\\u003C 5% marrow blasts at the time of transplant.\n  * Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible.\n* Acute lymphoblastic leukemia (ALL):\n\n  * Complete first remission (CR1) at high risk for relapse such as any of the following:\n\n    * Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.\n    * Failure to achieve MRD- complete remission after induction therapy.\n    * Persistence or recurrence of minimal residual disease on therapy.\n    * Any patient unable to tolerate consolidation and\u002For maintenance chemotherapy as would have been deemed appropriate by the treating physician.\n    * Other high-risk features not defined above.\n  * Complete second remission (CR2) or greater (CR2+).\n\n    * Note: ALL with less than 5% blasts at time of transplant but persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n* Other acute leukemias: Acute leukemias of ambiguous lineage or mixed phenotype with less than 5% blasts. Leukemias in morphologic remission with persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n* Chronic Myeloid Leukemia (CML): Excluding refractory blast crisis. To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy.\n* Myelodysplastic syndromes (MDS) and myeloproliferative disorders (MPD) other than myelofibrosis:\n\n  * MDS\u002FMPD overlap syndromes without myelofibrosis.\n  * MDS\u002F MPD patients must have less than 10% bone marrow myeloblasts and absolute neutrophil count (ANC) \\> 0.2 (growth factor supported if necessary) at transplant work-up.\n* Non-Hodgkin lymphoma (NHL) at high-risk of relapse or progression if not in remission:\n\n  * Eligible patients with aggressive histology (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell histology) in CR by PET\u002FCT imaging.\n  * Eligible patients with indolent B-cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2nd or subsequent progression with PR or CR by PET\u002FCT imaging.\n* Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in morphologic remission.\n* Only for adult patients, to prevent graft rejection, patients who received only non-lymphodepleting agents for their malignancy (hypomethylating agents, venetoclax, hydroxyurea, TKIs etc.), or patients who received lymphodepleting chemotherapy \\> 3 months prior to scheduled admission, may receive fludarabine 25 mg\u002Fm\\^2 daily x 3 days for lymphodepletion 14-42 days (aiming for 2-4 weeks) at the discretion of the principal investigator (PI).\n* For patients \\> 18 years old, Karnofsky score ≥ 70%. For patients =\\\u003C 18 years old, Lansky score ≥ 50%.\n* Calculated creatinine clearance \\> 70 ml\u002Fmin.\n* Bilirubin \\\u003C 1.5 mg\u002FdL (unless benign congenital hyperbilirubinemia or hemolysis).\n* Alanine transaminase (ALT) \\\u003C 3 x upper limit of normal (ULN).\n* For patients \\> 18 years old, pulmonary function (spirometry and corrected diffusing capacity for carbon monoxide \\[DLCO\\]) \\> 60% predicted. For patients =\\\u003C 18 years old, or any patient unable to perform pulmonary function tests, O2 saturation \\> 92% on room air.\n* Left ventricular ejection fraction \\> 50%.\n* Albumin \\> 3.0 g\u002FdL.\n* For patients \\> 18 years old, Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) =\\\u003C 5.\n* UCB units will be selected according to current umbilical cord blood graft selection algorithm. One or two UCB units may be used to achieve the required cell dose.\n* The UCB graft is matched at 4-6 HLA-A, B, DRB1 antigens with the recipient. This may include 0-2 antigen mismatches at the A or B or DRB1 loci. Unit selection based on cryopreserved nucleated cell dose and HLA-A, B, DRB1 using intermediate resolution A, B antigen and DRB1 allele typing.\n\nExclusion Criteria:\n\n* Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.\n* Patients persistent with central nervous system (CNS) involvement in cerebrospinal fluid (CSF) or CNS imaging at time of screening0\n* Prior checkpoint inhibitors\u002F blockade in the last 12 months.\n* Two prior stem cell transplants of any kind.\n* One prior autologous stem cell transplant within the preceding 12 months.\n* Prior allogeneic transplantation.\n* Prior involved field radiation therapy that would preclude safe delivery of 400cGy total body irradiation (TBI) in the opinion of radiation oncology.\n* Active and uncontrolled infection at time of transplantation.\n* HIV infection.\n* Inadequate performance status\u002F organ function.\n* Pregnancy or breast feeding.\n* Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.","65 Years",{"count":726,"type":22},54,[82],"This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic diseases. Giving chemotherapy, such as cyclophosphamide, fludarabine and thiotepa, and TBI before a donor cord blood transplant (CBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening in patients with high-risk hematologic diseases.",[669,29,162,672,643,675,284,646,647,730],"Chronic Myeloid Leukemia, BCR-ABL1 Positive","2026-07-20",{"date":707,"type":37},{"date":734,"type":37},"2024-07-23",{"date":736,"type":22},"2032-10-31",{"name":686,"class":97}]