[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rr-aml\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rr-aml":38},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,55,83,108],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":40,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"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",false,"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.","ALL","6 Months","17 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","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.",[28,29,30,31,32,33,34,35,36,37,38,39],"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","Acute Lymphoblastic Leukemia","Pediatric AML","R\u002FR AML","R\u002FR B-cell ALL",[39,38,37,36,35,34,33,32,31,28,29,41,42],"Sonrotoclax","Pediatric","NOT_YET_RECRUITING","2026-08-17",{"date":46,"type":47},"2026-08-18","ACTUAL",{"date":49,"type":21},"2026-10",{"date":51,"type":21},"2031-09",{"name":53,"class":54},"BeOne Medicines","INDUSTRY",{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":68,"conditions":69,"keywords":70,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100652095","phase-1-addition-of-hydroxyurea-to-fludarabine-cytarabine-idarubicin-and-venetoclax-salvage-therapy-for-adults-with-relapsed-or-refractory-acute-myeloid-leukemia-100652095","NCT07766850","Addition of Hydroxyurea to Fludarabine, Cytarabine, Idarubicin and Venetoclax Salvage Therapy for Adults With Relapsed or Refractory Acute Myeloid Leukemia","FLAsH-IV-AML: A Phase I\u002FII Multi-center Study to Assess the Tolerability and Efficacy of the Addition of Hydroxyurea to Salvage Treatment With Fludarabine, Ara-C, Idarubicin and Venetoclax for Adults With Relapsed or Refractory Acute Myeloid Leukemia","FLAsH-IV-AML","Inclusion Criteria:\n\n1. A diagnosis of either:\n\n   * Refractory AML defined as having \\> 10% bone marrow blasts after induction with one cycle of intensive chemotherapy or no CR after two cycles of chemotherapy.\n   * Relapsed disease (including extramedullary disease) according to the 2022 ELN criteria (see appendix A).\n   * MRD relapse defined as evidence of measurable (minimal) residual disease (MRD) at a level of ≥5%, as determined by either molecular assays or multiparameter flow cytometry.\n2. Age 18 years or older.\n3. ECOG Performance Status ≤ 2.\n4. Adequate renal and hepatic functions as indicated by the following laboratory values:\n\n   * Creatinine clearance ≥ 30 mL\u002Fmin calculated by the Cockcroft Gault formula.\n   * Serum bilirubin ≤ 3 x upper limit of normal (ULN), unless due to Gilbert's syndrome.\n   * Alanine aminotransferase (ALAT) ≤ 5 x ULN.\n5. Considered fit for intensive chemotherapy.\n6. Male patients must use a latex condom during any sexual contact with women of childbearing potential, even if they have undergone a successful vasectomy and must agree to avoid fathering a child (while on therapy and for 6 months after the final study drug administration). In addition, their female partners of childbearing potential must use a highly effective method of birth control.\n7. Male patient must not donate sperm starting at screening and throughout the study period and for 6 months after the final study drug administration.\n8. Female patients of nonchildbearing potential must be postmenopausal (defined as at least 1 year without any menses), documented surgically sterile prior to screening.\n9. Female patients of childbearing potential must agree to avoid pregnancy during the study and for 6 months after the final study drug administration and have a negative urine or serum pregnancy test at screening, and if heterosexually active, agree to consistently apply one highly effective method of birth control in combination to a barrier method for the duration of the study and for 6 months after the final study drug administration.\n10. The subject has given their written consent to participate in the trial.\n11. Patient is capable of giving informed consent.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia.\n2. WBC ≥30; pretreatment with HU to reduce the level of WBC \\\u003C30 is allowed in part B\u002Fphase II of the trial.\n3. TP53 double hit mutation \u002F biallelic TP53 inactivation.\n4. CNS leukemia.\n5. Relapse within 3 months from the date of allo-HCT.\n6. Uncontrolled infection.\n7. ECOG Performance Status \\> 2.\n8. Major organ failure precluding administration of planned chemotherapy\n9. Cardiac dysfunction as defined by:\n\n   * Myocardial infarction within the last 3 months of study entry, or\n   * Reduced left ventricular function with an ejection fraction \\\u003C 50% as measured by echocardiogram (will only be performed when clinically suspected) or\n   * Unstable angina or\n   * New York Heart Association (NYHA) grade III or IV congestive heart failure (see appendix C) or\n   * Severe cardiac arrhythmias\n10. Age 75 years or older.\n11. Known intolerance to any of the chemotherapeutic drugs in the protocol.\n12. Positive pregnancy test.\n13. Lactating female or female of childbearing potential not using adequate contraception.\n14. Known inherited bone marrow failure syndromes (e.g., Fanconi anemia, Dyskeratosis congenita and related telomeropathies (e.g., TERT, TERC, DKC1 mutations).\n15. Patients with a history of non-compliance to medical regimens or who are considered unreliable with respect to compliance.","18 Years","74 Years",{"count":66,"type":21},26,[24,25],"This study is evaluating a new treatment approach for adults with acute myeloid leukemia (AML) that has either returned after previous treatment or has not responded to treatment. Outcomes for these patients are often poor, and there is a need for more effective therapies.\n\nThe study is investigating whether adding hydroxyurea to a combination of established AML medicines (fludarabine, cytarabine, idarubicin, and venetoclax) is safe and tolerable and can improve treatment results. Laboratory studies suggest that hydroxyurea may help leukemia cells become more sensitive to treatment and may increase the effectiveness of chemotherapy.\n\nThe study is being conducted in two parts. In the first part, researchers will determine the safest and most appropriate dose of hydroxyurea when given together with the study treatment. In the second part, researchers will evaluate whether adding hydroxyurea improves treatment outcomes, including the length of time patients remain free from disease progression, relapse, or death.\n\nThe overall goal of the study is to determine whether adding hydroxyurea to standard treatment for relapsed or refractory AML is safe and may improve patient outcomes.",[38],[71,72,73],"Hydroxyurea","FLAG-Ida","Venetoclax","2026-08-11",{"date":44,"type":47},{"date":49,"type":21},{"date":78,"type":21},"2034-09",{"name":80,"class":81},"Christer C Nilsson","OTHER_GOV",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100622522","phase-1-first-in-human-fih-trial-of-gen3018-in-relapsed-or-refractory-rr-acute-myeloid-leukemia-aml-or-higher-risk-myelodysplastic-syndrome-hr-mds-100622522","NCT07384715","First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R\u002FR) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)","An Open-Label, Multicenter, First-in-Human Trial of GEN3018 in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome","Key Inclusion Criteria:\n\nAll Participants:\n\n* Be at least 18 years of age at the time of signing informed consent form (ICF).\n* Participant's life expectancy at screening is judged to be at least 3 months.\n* Must have fresh bone marrow samples collected at screening.\n* Bone marrow (BM) blasts ≥ 5% at screening.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2.\n* Has acceptable laboratory test results during the screening period\n\nParticipants with R\u002FR AML:\n\n* Relapsed or refractory AML, either de novo or secondary, and must have failed all conventional therapies.\n* Relapsed or refractory to at least one prior line of therapy.\n\nParticipants with R\u002FR HR-MDS:\n\n* Diagnosed with high- or very-high risk MDS according to International Prognostic Scoring System (IPSS-R) (score of \\> 4.5 ie, high or very high) or World Health Organization (WHO) 2022 classification (ie, MDS-IB1 or MDS-IB2).\n* Refractory or relapsed after hypomethylating agents (HMAs) (such as azacitidine or decitabine).\n\nKey Exclusion Criteria:\n\nAll Participants:\n\n* Diagnosis of acute promyelocytic leukemia (APL).\n* Presence of extramedullary AML at screening.\n* Prior autologous or allogenic hematopoietic stem cell transplant (HSCT) within 3 months prior to initiation of trial treatment.\n* Active graft-versus-host disease.\n* History of severe immune-related adverse events.\n* Treatment with anti-cancer agent (eg, small molecule, antibody, chemotherapy, radiation therapy), or major surgery within 2 weeks prior to the first dose of GEN3018.\n\nOther protocol-defined Inclusion and Exclusion criteria may apply.",{"count":91,"type":21},78,[24],"The drug that will be investigated in the trial is an antibody, GEN3018. Since this is the first trial of GEN3018 in humans, the main purpose is to evaluate safety. In addition to safety, the trial will determine the recommended GEN3018 dose(s) to be tested in a larger group of participants and assess preliminary anti-tumor activity of GEN3018. GEN3018 will be studied in refractory (resistant to treatment) or relapsed (disease has returned) acute myeloid leukemia (also known as R\u002FR AML) and refractory or relapsed higher-risk myelodysplastic syndrome (also known as R\u002FR HR-MDS). The trial consists of 2 parts:\n\n1. Part 1 Dose Escalation will test increasing doses of GEN3018 to identify a safe dose level to be tested in the next part\n2. Part 2 Dose Refinement will further test the GEN3018 dose(s) determined from the Dose Escalation.\n\nUp to 78 participants may be treated in this trial (up to 60 participants in Part 1; up to 18 participants in Part 2).\n\nFor an individual participant in the trial, the estimated treatment duration will be up to 1 year. Participation in the trial will require regular scheduled visits to the site. At site visits, there will be various tests (such as blood draws) to monitor whether the treatment is safe and effective. Participants will also be contacted every 3 months after treatment ends to monitor how they are doing.\n\nAll participants in the trial will receive active drug (ie, GEN3018); no one will be given placebo.",[38,95,35,96],"R\u002FR HR-MDS","Higher-Risk Myelodysplastic Syndrome","RECRUITING","2026-08-03",{"date":100,"type":47},"2026-08-04",{"date":102,"type":47},"2026-02-16",{"date":104,"type":21},"2030-04-20",{"name":106,"class":54},"Genmab",6,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":63,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":117,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":4},"100618842","early-phase-1-clinical-study-of-novel-car-itnk-cells-targeting-cd70-and-cll1-for-refractoryrelapsed-aml-100618842","NCT07336875","Clinical Study of Novel CAR-ITNK Cells Targeting CD70 and CLL1 for Refractory\u002FRelapsed AML","Clinical Study of Novel CAR-ITNK Cells Targeting CD70 and CLL1 for Refractory\u002FRelapsed Acute Myeloid Leukemia","Inclusion Criteria:\n\n1\\. The patient or their legal guardian voluntarily participates and has signed the informed consent form.\n\n2\\. Age between 18 and 75 years old (inclusive), with no gender restrictions. 3. Diagnosed as having refractory\u002Frelapsed acute myeloid leukemia, meeting one of the following criteria:\n\n1. . Reappearance of leukemic cells in peripheral blood after achieving complete remission, or bone marrow blast count \\> 5% (excluding other causes such as bone marrow reconstitution post-consolidation chemotherapy), or the presence of extramedullary leukemic cell infiltration.\n2. . Ineligible for bone marrow transplantation, or have undergone bone marrow transplantation but failed to achieve long-term remission.\n\n4\\. Expression of both CLL-1 and CD70 targets is confirmed as positive by flow cytometry.\n\n5\\. Patients must have good major organ function:\n\n1. . Liver function: ALT\u002FAST \\\u003C 3 times the upper limit of normal (ULN) and total bilirubin ≤ 34.2 μmol\u002FL.\n2. . Kidney function: Creatinine clearance rate (Cockcroft-Gault method) ≥ 60 mL\u002Fmin.\n3. . Lung function: Oxygen saturation ≥ 95%, with no active pulmonary infection.\n4. . Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; no significant pericardial effusion, and no clinically significant ECG abnormalities.\n\n6\\. Women of childbearing age must have a negative urine\u002Fblood pregnancy test during screening and agree to use contraceptive measures for at least 1 year after infusion. Male subjects with reproductive capacity must agree to use effective barrier contraception for at least 1 year after infusion.\n\n7\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. 8. Expected life expectancy greater than 3 months. 9. The patient is willing to cooperate with the collection of peripheral blood mononuclear cells, medical examinations, and regular follow-up visits.\n\nExclusion Criteria:\n\nThe patient will be excluded if meeting any of the following criteria:\n\n1. Women who are pregnant or breastfeeding.\n2. Presence of uncontrolled fungal, bacterial, treponemal (e.g., syphilis), viral, or other infections.\n3. Active hepatitis B (Hepatitis B virus DNA \\> 500 IU\u002FmL) or a positive Hepatitis C virus RNA (HCV-RNA) test.\n4. Human Immunodeficiency Virus (HIV) infection, or syphilis infection.\n5. Previously received any form of gene therapy.\n6. The patient has an allergic constitution or is allergic to macromolecular biologics such as antibodies or cytokines.\n7. History of clinically significant central nervous system diseases, such as: epilepsy, hemiparesis, aphasia, stroke, severe brain trauma, dementia, Parkinson's disease, cerebellar diseases, or organic brain syndromes.\n8. Uncontrolled psychiatric illness.\n9. A history of drug abuse\u002Faddiction.\n10. Use of prohibited medications:\n\n(1). Hormones: Use of corticosteroids (prednisone ≥ 2 mg\u002Fkg or equivalent \\> 20 mg\u002Fday) within 2 weeks prior to cell collection. Recent or ongoing use of inhaled, topical, or non-absorbable steroids is not an exclusion criterion.\n\n(2). Radiotherapy\u002FChemotherapy:Receipt of radiotherapy or salvage chemotherapy for the study disease within 3 weeks prior to cell collection.\n\n(3). Use of immunosuppressive agents within 4 weeks prior to cell collection. (4). Participation in another clinical trial or receipt of a major non-diagnostic surgical procedure within 4 weeks prior to cell collection.\n\n(5). Use of alemtuzumab within 6 months, or cladribine\u002Fclofarabine within 3 months, prior to cell collection.","75 Years",{"count":20,"type":21},[118],"EARLY_PHASE1","The purpose of this clinical trial is to evaluate the safety and efficacy of CAR-ITNK cells therapy targeting CD70 and CLL1 in participants with relapsed\u002Frefractory Acute Myeloid Leukemia. Participants will receive a single infusion of CAR-ITNK cell therapy targeting CD70 and CLL1 and complete follow-ups over the next three years.",[38],[122,123],"CAR-ITNK","CD70&CLL1","2026-01-04",{"date":126,"type":47},"2026-01-13",{"date":128,"type":21},"2026-02-28",{"date":130,"type":21},"2029-02-28",{"name":132,"class":133},"Tongji Hospital","OTHER"]