[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphoma":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,211,0,25,[9,50,74,105,132,158,181,206,232,256,274,301,325,346,377,409,432,452,477,499,527,570,591,617,641],{"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":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100633272","stem-cell-transplantation-for-participants-with-germline-runx1-associated-blood-cancers-100633272",false,"NCT07524530","Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers","Phase II Haploidentical Hematopoietic Stem Cell Transplantation for Participants With Germline RUNX1 Associated Hematologic Malignancies","* INCLUSION CRITERIA:\n* Affected participants (Recipients)\n\n  * History of deleterious or suspected deleterious (defined as P\u002FLP or VUS with RUNX1 phenotype) germline RUNX1 mutation as defined by ClinVar (nih.gov)\n  * Histological confirmation of a myeloid malignancy - acute or chronic leukemia (\\\u003C5% marrow blasts preferred) or myelodysplastic syndrome\u002Fmyeloproliferative neoplasms (MDS\u002FMPN) (\\\u003C10% marrow blasts preferred). Participants may be treated on this study to achieve preferred blast cutoffs. Participants with poorly responsive or relapsed disease remain eligible and may proceed as the graft-versus-leukemia (GVL) effect may produce cures.\n\nSubjects requiring standard therapies to prepare for HCT should ideally be referred to this study in remission, if possible. However, sometimes disease status changes during evaluation for HCT and it is necessary to establish disease control through the administration of standard therapies during evaluation for HCT. If ongoing therapy for the underlying disease outside of the NIH is not in the best interest of the subject according to the clinical judgment of the NIH PI, then the subject may receive standard treatment for his\u002Fher underlying hematologic malignancy as a bridge to HCT on this protocol, prior to starting the research phase of the study. If it becomes apparent that the subject will not be able to proceed to HCT, then he\u002Fshe must come off study. Subjects receiving standard therapy will be told about the therapy, associated risks, potential benefits, alternatives to the proposed therapy, and the availability of receiving the same treatment elsewhere, outside of a research protocol.\n\n* Availability of a haploidentical donor (HLA-match only).\n* Age \\>= 4 and \\\u003C= 70 years\n* Karnofsky (\\>=16 years) or Lansky (\\\u003C16 years) \\>=60%\n* For human immunodeficiency virus (HIV)-infected participants, participant must be on effective anti-retroviral therapy, without uncontrolled opportunistic infection and have approval via Transplant Infectious Disease consultation. Consider donor with CCR5(delta)32 homozygosity for these participants.\n* For individuals with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load (VL) must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV VL.\n* Contraception as follows:\n\n  ---Women of child-bearing potential (WOCBP) must agree to use highly effective contraception (hormonal, intrauterine device \\[IUD\\], abstinence, surgical sterilization) at the study entry and up to and 12 months post conditioning and\u002For post-transplant.\n* Men that can father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 12 months posttransplant or 4 months after conditioning if transplant is not done. We also will recommend men that can father children with partners that can bear children ask their partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Men that can father children must not freeze or donate sperm within the same period.\n* Breastfeeding participants must be willing to discontinue breastfeeding during the study and for 12 months post-transplant or 1 week after conditioning if transplant is not done.\n* Willingness to remain in the NIH hospital or, if discharged, stay close to the NIH (30 minutes drive), for a minimum of 100 days after transplant or longer if there are complications. The participants must commit to having an adult caregiver with them during the first 100 days after the transplant\n* Participants or parent\u002Fguardian\u002Flegally authorized representative must be able to understand and willing to sign a written informed consent document.\n* Additional criteria for recipients suitable for MAC\n\n  * Age \\\u003C= 65 years\n  * HCT-CI \\\u003C4\n  * Pulmonary function tests (PFTs): Forced expiratory volume in the first second (FEV1) and adjusted diffusion capacity of carbon monoxide (DLCO) \\>=66%, without dyspnea at rest or oxygen requirement. If too young to cooperate with PFTs, must have \\>=92% oxygen saturation on room air and no dyspnea at rest.\n  * Left ventricular ejection fraction (LVEF) \\>=50% by echocardiogram (ECHO) or Multigated Acquisition (MUGA) scan (101)\n  * Recipients must have adequate organ function as defined below:\n\n    * Total bilirubin \\\u003C1.5 x institutional upper limit of normal (iULN) (unless Gilbert disease, hemolysis)\n    * Aspartate aminotransferase (AST) \u002F Alanine aminotransferase (ALT) \\\u003C=2.5 x iULN (unless therapy related and will improve in discussion with the National Institute of Diabetes and Digestive and Kidney Diseases \\[NIDDK\\])\n    * Creatinine within normal institutional limits or 24-hour urine or calculated creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for individuals with creatinine levels above institutional normal (calculated using the Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n* Additional criteria for recipients suitable for RIC\n\n  * Age \\\u003C=70 years\n  * PFTs: FEV1 and DLCO \\>=50%, without dyspnea at rest or oxygen requirement. If too young to cooperate with PFTs, must have \\>=92% oxygen saturation on room air and no dyspnea at rest\n  * LVEF \\>=40% by ECHO or MUGA obtained within 2 months of HSCT (Children s Oncology Group \\[COG\\] criteria).\n  * Recipients must have adequate organ function as defined below:\n\n    * Total bilirubin \\\u003C2.5 x iULN (unless Gilbert disease, hemolysis)\n    * AST\u002FALT \\\u003C3.5 x iULN (unless therapy related and will improve in discussion with NIDDK)\n    * Creatinine within normal institutional limits or 24-hour urine or calculated creatinine clearance \\>=50 mL\u002Fmin\u002F1.73 m\\^2 for individuals with creatinine levels above institutional normal (calculated using the CKD-EPI equation)\n* Unaffected participants\n\n  * Haploidentical donors\n\n    ----Age \\>=4 years\n  * Participants or parent\u002Fguardian must be able to understand and willing to sign a written informed consent document.\n  * Unaffected family members\n\n    * Age \\>=18 years\n    * If the participant is a blood relative of the recipient, participant must be negative for RUNX1 mutations by molecular testing\n    * Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n-All participants\n\n* Recipients who are receiving any investigational agent except virus specific T cells (VST)\n* Active non-hematologic malignancies\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the drugs used in study.\n* Participants with the following cardiac conditions: symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (except atrial fibrillation if cleared by cardiology consultation)\n* Participants without access to medical care at home.\n* Positive serum or urine beta-human chorionic gonadotropin (beta-hCG) test at screening\n* Uncontrolled intercurrent illness evaluated by history, physical exam, and laboratory studies or situations that would limit compliance with study requirements, interpretation of results or that could increase risk to the participant","ALL","4 Years","70 Years",{"count":21,"type":22},98,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Background:\n\nSome blood cancers can be caused by germline variants (changes) in a person s RUNX1 gene. Germline variants are genetic inherited changes a person is born with. Stem cell transplants are used to treat many diseases including blood cancers. Stem cell transplantation for patients with germline RUNX1 mutation driven blood cancers is standard of care and available in most major medical centers. The difference with this transplantation protocol is that it is prospective, only available to participants with germline RUNX1 variants and designed to determine the extent to which tailoring chemotherapy and supportive care medication doses for each individual patient may improve outcomes compared to data derived from retrospective transplantation protocols for patients with RUNX1 varinats which is less accurate.\n\nObjective:\n\nThe primary objective of this protocol is to determine how tailored doses of chemotherapy and supportive care medications may improve disease free survival as compared to historical\u002Fexpected disease free survival.\n\nEligibility:\n\nPeople aged 4 to 70 years with blood cancer caused by a RUNX1 gene mutation. Other participants are also needed: (1) stem cell donors; (2) relatives who do not have a mutation in the RUNX1 gene; and (3) healthy volunteers.\n\nDesign:\n\nParticipants with blood cancer will be screened during approximately 1-3 months before transplatation. They will have blood tests and tests of their heart and lung function. A sample of bone marrow may be taken.\n\nA flexible tube (central line) will be inserted into a vein in participants chest or lower neck. This line will remain in place during the hospitalization and be used to draw blood and administer drugs. These lines are almost always transitioned to a peripherally inserted central catheter (PICC) line at the time of hospital discharge.\n\nParticipants will be inpatient for 4 to 5 weeks. They will receive drugs to prepare their body for the stem cell transplant. Some may also receive radiation treatment. Other tests will include imaging scans. The stem cell transplant will be given through the central line.\n\nAfter discharge from the clinic, participants will have follow-up visits at least once per week for approximately 100 days. Then they will have follow-up clinic visits for 3 years.\n\nDonors, relatives, and healthy volunteers may provide samples of blood, stool, and saliva. Adults may also opt to provide samples of skin and bone marrow.",[28,29,30,31],"Core Binding Factor Alpha Subunits","Hematologic Neoplasms","Leukemia","Lymphoma",[33,34,35,36],"RUNX1","Haploidentical Hematopoietic Stem Cell Transplant","Germline RUNX1","germline RUNX1-aassociated myeloid malignancy","NOT_YET_RECRUITING","2026-08-20",{"date":40,"type":41},"2026-08-21","ACTUAL",{"date":43,"type":22},"2026-08-26",{"date":45,"type":22},"2036-06-01",{"name":47,"class":48},"National Cancer Institute (NCI)","NIH",1,{"id":51,"slug":52,"hasResults":12,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":49},"100652824","phase-2-cd19cd22-car-t-consolidation-in-rr-aggressive-b-cell-lymphoma-after-second-line-therapy-100652824","NCT07779018","CD19\u002FCD22 CAR-T Consolidation in R\u002FR Aggressive B-Cell Lymphoma After Second-Line Therapy","An Exploratory Clinical Study on CAR-T Cell Immunotherapy Targeting CD22\u002FCD19 for Consolidation Therapy in Relapsed\u002FRefractory Aggressive B-cell Lymphoma After Second-line Treatment","Inclusion Criteria:\n\n* 1\\. With the patient's consent and signed informed consent form, willing and able to comply with the planned visits, research treatments, laboratory tests, and other experimental procedures; 2. CD19 and\u002For CD22-positive large B-cell lymphoma (LBCL) diagnosed by cytology or histology according to WHO 2016 criteria, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), etc., whose disease has achieved complete response (CR) after induction treatment with a standard second-line chemotherapy regimen and who are within 3 months from the time of CR.\n\n  3\\. The possible high-risk factors for the patient's onset of the disease are as follows: 1) FISH confirmed high-grade B-cell lymphoma with double or triple strikes, accompanied by MYC and BCL2 and\u002For BCL6 rearrangements; 2) Advanced B-cell lymphoma with 11q abnormalities\u002FBurkitt like lymphoma with 11q abnormalities; 3) The International Prognostic Index (IPI) at the time of initial diagnosis is 2-5 points; The Age Adjusted International Prognostic Index (aaIPI) is 2-3 points; The National Comprehensive Cancer Network International Prognostic Index (NCCN-IPI) score ranges from 4-8 points in the United States; 4) Immunohistochemical CD5 positivity; 5) Immunohistochemistry suggests dual expression of MYC and BCL-2 (recommended dual expression threshold is MYC ≥ 40%, BCL2 ≥ 50%); 6) Gene sequencing shows TP53 mutation; 7) The second-generation sequencing (NGS) suggests molecular typing as MCD subtype and N1 subtype; 4. Age range from 18 to 85 years old, male or female; 5. Subjects with physical fitness status scores ranging from 0 to 2 in the Eastern Cooperative Oncology Group (ECOG) in the United States; 6. Expected survival period from the date of signing the informed consent form is greater than 3 months; 7. HGB ≥ 60g\u002FL; 8. The absolute value of neutrophils in peripheral blood is ≥ 1000\u002Fμl, and the platelet count is ≥ 45000\u002Fμl; 9. Liver and kidney function, as well as heart and lung function, meet the following requirements: 1) Total bilirubin (TBIL) ≤ 1.5 times the upper limits of normal (ULN), except for subjects with Gilbert's syndrome; 2) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN; 3) Serum Creatinine (Cr) ≤ 1.5 times ULN or Creatinine Clearance Rate (CCr) ≥ 60mL\u002Fmin, estimated based on the Cockcroft Gault formula; 4) The left ventricular ejection fraction (LVEF) of the heart is ≥ 50%. Echocardiography (ECHO) confirms no pericardial effusion and no clinically significant arrhythmia; 5) Baseline transcutaneous oxygen saturation under indoor ventilation\\>92%; 6) No clinically significant pleural effusion; 10. Participants with pregnancy plans must agree to take contraceptive measures for a continuous period of 6 months from before enrollment in the study until the end of the study; If the subject is pregnant or suspected of being pregnant, the researcher should be notified immediately.\n\n  11.Patients who are not eligible for hematopoietic stem cell transplantation (HSCT) or who refuse HSCT.\n\nExclusion Criteria:\n\n* 1\\. Have received any form of chimeric antigen receptor cell therapy or other genetically modified T cell therapy; 2. Has a history of severe immediate hypersensitivity reactions to aminoglycoside antibiotics and other essential medications; 3. Known history of human immunodeficiency virus (HIV) infection or active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics (active HBV infection is defined as: a. HBV DNA quantification ≥ 2000 IU\u002Fml; b. ALT ≥ 2 times the normal upper limit value; c. Exclude hepatitis caused by the disease itself, medication, or other reasons; All three conditions must be met simultaneously. If a patient is diagnosed with active HBV infection at the time of initial diagnosis and becomes non active HBV infection after anti HBV treatment, they can be included in this study under the premise of sufficient anti HBV treatment; 4. Non hematological tumors (such as lymphoma) associated liver and kidney dysfunction: ALT\\>3 times the upper limit of normal, AST\\>3 times the upper limit of normal, TBIL\\>2 times the upper limit of normal, serum creatinine clearance rate\\\u003C30 mL\u002Fmin; 5. History of myocardial infarction, cardiac angioplasty or coronary stent implantation, unstable angina, active arrhythmia, or other clinically significant cardiovascular diseases within the 12 months prior to enrollment; 6. Other serious medical diseases may have an impact on this study (such as diabetes, gastric ulcer, other serious respiratory and circulatory diseases, severe autoimmune diseases or congenital immune defects, severe infection and inability to be effectively controlled), as well as other diseases with high risk of disease change; 7. Has a history of severe immediate hypersensitivity reactions to any medication necessary for use in this study; History of severe allergy to biological products (including antibiotics); 8. Female subjects who are currently pregnant or breastfeeding (with potential risks to the fetus or infant from pre-treatment chemotherapy regimens); 9. The researchers determined that the subjects were unable to complete all the required visit surveys or diagnostic procedures (including medium - and long-term follow-up visits) as per the study protocol, had poor willingness to participate in the study, were unwilling to join and fully comply with the study arrangements, and had insufficient compliance with the study by the subjects and their families. The decision-making power belongs to the researcher; 10. The subjects who have previously suffered from other malignant tumors cannot be included in this study unless they are disease-free and have not received any form of anti-tumor treatment for at least 3 years (except for skin tumors of non malignant melanoma and in situ cancers occurring in the cervix, bladder, breast, etc.); 11. History of receiving live vaccines within 6 weeks prior to initiating the pre-treatment plan; 12. Those who have undergone large-scale surgical treatment (excluding lymph node biopsy) within the past 14 days, or those who are expected to undergo large-scale surgical treatment during the treatment process; 13. There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the study results, as well as patients deemed unsuitable by the researchers to participate in this study.","18 Years","85 Years",{"count":60,"type":22},30,[25],"The purpose of this study is to determine the efficacy and safety of CD22\u002FCD19-targeted CAR-T cell immunotherapy as consolidation therapy after second-line treatment in patients with high-risk aggressive B-cell lymphoma.",[31],"RECRUITING","2026-08-19",{"date":40,"type":41},{"date":68,"type":41},"2026-04-01",{"date":70,"type":22},"2028-03-01",{"name":72,"class":73},"Liping Dou","OTHER",{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":49},"100565662","feasibility-of-intermittent-fasting-during-chemotherapy-100565662","NCT06645093","Feasibility of Intermittent Fasting During Chemotherapy","Intermittent Fasting During Curatively Intended Chemotherapy for Malignant Lymphoma - a Randomized Feasibility Trial","FasteStudien","Inclusion Criteria:\n\n* Patients diagnosed with diffuse large B-cell lymphoma planned to receive R-CHOP (rituximab, vincristine, doxorubicin, cyclophosphamide, and prednisolone) and Hodgkin lymphoma receiving ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine)\n* Age ≥ 18 years\n* ECOG status 0-2\n* Normal weight and overweight (BMI ≥ 18,5 kg\u002Fm\\^2)\n\nExclusion Criteria:\n\n* Receiving concurrent radiation therapy and\u002For treatment\n* Other concomitant disease that may make intermittent fasting complicated such as diabetes mellitus\n* ECOG status: \\> 3\n* BMI \\\u003C 18,5 kg\u002Fm2\n* Age \\> 80 years","80 Years",{"count":84,"type":22},40,[86],"NA","The goal of this randomized controlled parallel group trial is to examine if fasting before and after chemotherapy is safe, feasible and acceptable. The study population will include patients with either Hodgkin lymphoma or Diffuse Large B Cell Lymphoma.\n\nThe main questions aimed to answer are:\n\nWhether fasting during chemotherapy is safe for patients, whether it is feasible to implement in a clinical setting, and whether patients find it acceptable.\n\nWe also want to examine a number of patient-reported outcome measures regarding health status and quality of life, such as dietary intake and adverse events from chemotherapy.\n\nResearchers will compare fasting to standard treatment.\n\nParticipants will:\n\n* Fast 24 hours before and 24 hours after chemotherapy in addition to standard treatment or receive only standard treatment\n* Keep a diary of their dietary intake 24 hours before and 24 hours after chemotherapy\n* Keep a diary of their dietary intake for three consecutive days between chemotherapy cycles\n* Answer questionnaires\u002Fquestions in relation to side effects from fasting, side effects\u002Fadverse events of chemotherapy, quality of life\n* Take bioimpedance analysis (including body mass index and body composition)\n* Take blood- and feces samples",[31,89,90],"Cancer","Fasting",[92,93,94,95,96,90],"Chemotherapeutic Toxicity","Chemotherapy","Adverse Effect","Short-term fasting","Feasibility studies","2026-08-18",{"date":38,"type":41},{"date":100,"type":41},"2024-10-31",{"date":102,"type":22},"2026-12",{"name":104,"class":73},"University of Oslo",{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":17,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":122,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":49},"100431492","improving-cognitive-function-in-older-adults-undergoing-stem-cell-transplant-100431492","NCT04898790","Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant","Promoting Physical Activity to Improve Cognitive Function in Older Adults Undergoing Hematopoietic Cell Transplantation","PROACTIVE","Arm 1:\n\nInclusion Criteria for Participants:\n\n* age 60 years and older\n* have a diagnosis of hematological malignancy\n* have received autologous or allogeneic HCT within the prior 3-6 months\n* able to speak and read English\n* have provided written informed consent\n\nExclusion Criteria for Participants:\n\n* there are no exclusion criteria\n\nInclusion Criteria for Participants' Care-Partner:\n\n* age 19 years and older\n* able to speak and read English\n\nExclusion Criteria for Participants' Care-Partner:\n\n* there are no exclusion criteria\n\nInclusion Criteria for Transplant Team Member:\n\n* age 19 years and older\n* able to speak and read English\n\nExclusion Criteria for Transplant Team Member:\n\n* there are no exclusion criteria\n\nArms 2 and 3:\n\nInclusion Criteria for Participants:\n\n* age 55 years and older\n* have a diagnosis of hematological malignancy\n* planned to receive an autologous or allogeneic HCT\n* able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)\n* (In Arm 3 only): willingness to be randomized to either initiate the physical activity intervention pre-HCT or following Day 180 post-HCT, and to follow the protocol for the group to which they have been assigned\n* able to speak and read English\n* have provided written informed consent\n\nExclusion Criteria for Participants:\n\n* development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)\n* is not cleared to participate in exercise by a physician\n\nIndividuals with the following current conditions\u002Fdiagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:\n\n* Myocardial infarctions in the past 3 months\n* Resting or unstable angina\n* Uncontrolled and\u002For serious arrhythmias\n* 3rd degree heart block\n* Acute congestive heart failure or ejection fraction \\\u003C30%\n* Clinically significant aortic stenosis\n\nIndividuals with the following conditions\u002Fdiagnoses will be required to provide clearance for exercise from their surgeon:\n\n* Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months\n\n  * other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition\n  * (In Arm 3 for those who agree to the voluntary measures of blood, saliva and MRI, there are additional exclusions to avoid conditions that may confound study outcomes):\n* history of residual brain abnormalities from prior severe traumatic brain injury (e.g. encephalomalacia) or other significant abnormalities documented on a recent brain MRI (e.g. brain cancer, large vessel strokes, residual subdural hematoma)\n* history of major stroke with obvious residual deficits\n* history of relapsing and remitting Multiple Sclerosis\n* active moderate to severe psychiatric symptoms due to primary psychiatric disorder\n\nInclusion Criteria for Participants' Care-Partner:\n\n* age 19 years and older\n* able to speak and read English\n* able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)\n* have no medical contraindications for participating in light to moderate-intensity physical activity per PI review of medical history as reported on the care-partner medical history form\n\nExclusion Criteria for Participants' Care-Partner:\n\n* development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)\n* is not cleared to participate in exercise by a physician\n\nIndividuals with the following current conditions\u002Fdiagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:\n\n* Myocardial infarctions in the past 3 months\n* Resting or unstable angina\n* Uncontrolled and\u002For serious arrhythmias\n* 3rd degree heart block\n* Acute congestive heart failure or ejection fraction \\\u003C30%\n* Clinically significant aortic stenosis\n\nIndividuals with the following conditions\u002Fdiagnoses will be required to provide clearance for exercise from their surgeon:\n\no Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months\n\n* other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition\n\nInclusion Criteria for Transplant Team Member:\n\n* age 19 years and older\n* able to speak and read English\n\nExclusion Criteria for Transplant Team Member:\n\n* there are no exclusion criteria","19 Years",{"count":115,"type":22},114,[86],"Cancer and treatment-related cognitive changes, such as thinking or remembering, hinder resumption of normal routine and roles and worsen quality of life. Older adults undergoing hematopoietic cell transplantation (HCT) are at high-risk for cognitive impairment. Age is a risk factor for Alzheimer's Dementia (AD) and the hematological malignancies leading to HCT. There are shared mechanisms and interactions between AD and cancer-related cognitive decline (CRCD). Physical activity improves cognitive function in older adults and survivors of other cancers. This study hypothesizes that increasing physical activity can also improve cognitive function in this vulnerable population.\n\nThe study has two goals. The first is to adapt and test an evidence-based physical activity intervention, The Community Health Activities Model Program for Seniors II (CHAMPS II), in the HCT setting for adults 55 years and older. This will be done using semi-structured interview of up to 10 patients who have experienced the HCT process within the last 3 to 6 months with HCT care-team partners.\n\nThe second goal will explore the prevalence and impact of AD-neuropathology and inflammation on cancer-related cognitive decline (CRCD) in older adults undergoing HCT.",[30,31,119,120,121],"Multiple Myeloma","Myelodysplastic Syndromes (MDS)","Myeloproliferative Neoplasm",[123],"Hematopoietic cell transplantation","2026-08-17",{"date":65,"type":41},{"date":127,"type":41},"2021-11-18",{"date":129,"type":22},"2027-07",{"name":131,"class":73},"University of Nebraska",{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":17,"minAge":140,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},"100457545","cognitive-aftereffects-of-neurotoxicity-in-children-and-young-adults-with-relapsedrefractory-hematologic-malignancies-who-receive-car-t-cell-therapy-100457545","NCT05237986","Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed\u002FRefractory Hematologic Malignancies Who Receive CAR T-cell Therapy","Investigation of the Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed\u002FRefractory Hematologic Malignancies Who Receive CAR T-cell Therapy","* INCLUSION CRITERIA:\n* Participants with disease\n\n  * Participants are diagnosed with relapsed\u002Frefractory leukemias or lymphomas, and are scheduled to receive CAR T-cell treatment in one of the enrolling sites\n  * For participants enrolled on a CAR T-cell treatment protocol, data sharing for the purposes of this study must be allowed.\n  * Age \\>= 5 and \\\u003C=35 years old\n  * Participant must have an eligible caregiver (informant) who is willing to complete assessments about the participant of this study\n  * Participants (\\\u003C18 years, or \\>=18 years if needed) must have an eligible caregiver to assist with setting up an appropriate test environment for the remote evaluations\n  * Participant must be able to speak and understand English or Spanish\n  * Participants must have access to a computer or tablet with a camera and an internet connection\n  * Participant or parent\u002Fguardian must be able to understand and willing to sign a written consent document\n* Caregivers (informants)\n\n  * Participants must be able to speak and read in English or Spanish\n  * Participants who are caregivers for participants with disease addressed above\n  * Age \\>= 18 years old\n  * Participants must have access to a computer or tablet\n  * Participants (of children \\\u003C18 years, or \\>18 years if needed) must be willing to help set up an appropriate test environment for the remote evaluations\n  * Participant is able to understand and willing to sign a written consent document\n\nEXCLUSION CRITERIA:\n\n-Participants with disease who have a pre-existing global intellectual disability (e.g., Down Syndrome)",true,"5 Years",{"count":142,"type":22},60,"OBSERVATIONAL","Background:\n\nCAR T-cell therapy is a promising new treatment for blood cancers. During treatment, a person s T-cells are genetically changed to kill cancer cells. Researchers want to learn more about the effects of potential problems that may be associated with this treatment. We are specifically interested in learning if and how this treatment may affect the brain or your thinking skills.\n\nObjective:\n\nTo learn if CAR T-cell therapy can affect how children and adults think, process, and remember things.\n\nEligibility:\n\nPeople aged 5-35 who have blood cancer that has not responded to treatment, or the blood cancer has come back after treatment, and who will receive CAR T-cell therapy. Caregivers are also needed. All participants must be able to speak and read in English or Spanish.\n\nDesign:\n\nParticipants will be screened with a medical history.\n\nInformation from participants medical records will be collected.\n\nParticipants will take tests at home or at NIH to see how well they think, read, learn, remember, reason, and pay attention. The tests will be both computerized and paper\u002Fpencil. They will take less than 1 hour to complete.\n\nParticipants and a parent\u002Fadult observer will complete a 5-minute Background Information Form and a checklist of nervous system symptoms.\n\nIf participants are 5 years or older, they will participate in activities to test their ability to do different thinking tasks, like answer questions, complete puzzle patterns, and remember things.\n\nParticipants and their caregivers will complete questions to see if they are having specific symptoms related to receiving CAR T-cells. The questions will assess their well-being and needs. The questions will take less than 1 hour to complete.\n\nSome tests and questions will be repeated at different time points in the study.\n\nParticipation will last for up to 3 years....",[31,30],[147,148,30,31,149],"Cogstate","Memory","Natural History","2026-08-15",{"date":97,"type":41},{"date":153,"type":41},"2025-06-23",{"date":155,"type":22},"2028-12-01",{"name":47,"class":48},3,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":17,"minAge":165,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":168,"conditions":169,"keywords":173,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":49},"100305619","phase-2-nivolumab-in-epstein-barr-virus-ebv-positive-lymphoproliferative-disorders-and-ebv-positive-non-hodgkinlymphomas-100305619","NCT03258567","Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas","Phase 2 Trial of Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-Hodgkin Lymphomas","* INCLUSION CRITERIA:\n* Subjects must have histologically or cytologically confirmed EBV-positive LPD or an EBV-positive NHL confirmed by the Laboratory of Pathology, NCI.\n\n  * EBV-positive LPD. Subjects may be previously untreated or relapsed from prior therapy.\n\n    1. Lymphomatoid granulomatosis (LYG), grades I-II\n    2. Chronic active EBV disease (CAEBV) of B-cells or T-cells\n    3. EBV-positive post-transplantation lymphoproliferative disorder (PTLD)\n\n       NOTE: PTLD after solid organ transplantation is excluded. Patients who, at the discretion of the investigator, need urgent therapy with standard agents will not be eligible.\n  * EBV-positive B-cell NHL. Subjects must have relapsed from previous treatment with an anthracycline and rituximab-based regimen or be considered not eligible for the same.\n\n    1. Lymphomatoid granulomatosis (LYG), grade III\n    2. EBV-positive immunodeficiency-associated diffuse large B-cell lymphoma (DLBCL)\n    3. EBV-positive DLBCL\n* Subjects must be at least 2 weeks from prior anti-lymphoma therapy (including radiation therapy)\n* Subjects must be at least 100 days from prior stem cell transplant (autologous or allogeneic) or Donor Lymphocyte Infusion (DLI)\n\n  * Age \\>=12 years\n  * Patients \\>= 12 and \\\u003C 18 years of age should weigh at least 40 kilograms (kg); there is no weight requirement for adult subjects.\n  * NOTE: If a pediatric patient is identified for possible enrollment who weighs less than 40 kg, the safety of the nivolumab dosing strategy used in this study must be discussed with the PI and manufacturer to confirm safety, and this discussion\u002Fapproval for enrollment documented in the medical record prior to declaring the pediatric patient eligible.\n* Adequate performance status as follows:\n\n  * Patients \\>= 16 years must have ECOG Performance Status 0-2 (Karnofsky \\>=60%)\n  * Pediatric patients \\\u003C 16 years must have Lansky play-performance of 60-100%\n* Subjects must have measurable or evaluable disease.\n* Subjects must have adequate organ and bone marrow reserve (unless disease-related) as defined below:\n\n  * absolute neutrophil count - \\>= 750\u002FmcL; \\>= 500\u002FmcL if impairment is due to LPD\u002FNHL\n  * platelets - \\>= 50,000\u002FmcL; \\>= 25,000\u002FmcL if impairment is due to LPD\u002FNHL (transfusions not permitted)\n  * Hemoglobin - \\>= 9g\u002FdL (transfusion permitted)\n  * total bilirubin - \\\u003C 3.0g\u002Fdl OR \\\u003C 5.0g\u002Fdl if Gilbert s syndrome or disease infiltration of the liver is present\n  * AST(SGOT)\u002FALT(SGPT) - \\\u003C= 3 X institutional upper limit of normal\n  * serum creatinine OR creatinine clearance - Adults: \\\u003C= 1.5 mg\u002FdL; Minors: serum Cr \\\u003C= age-adjusted normal OR \\>= 40 ml\u002Fmin\u002F1.73m\\^2\n\nAge(Years) 12-15: Maximum Serum Creatinine (mg\u002Fdl): 1.2\n\nAge(Years) \\> 15: Maximum Serum Creatinine (mg\u002Fdl): 1.5\n\n* A formalin fixed tissue block or at least 15 slides of tumor sample (archival or fresh) must be available for performance of correlative studies. NOTE: Patient must be willing to have a pre-treatment tumor biopsy if adequate archival tissue is not available.\n* The toxicity profile of nivolumab in patients with disease involvement of the central nervous system (CNS) is unknown. For this reason, we will introduce early stopping rules.\n* The effects of nivolumab on the developing human fetus are unknown. For this reason, the following measures apply:\n\n  * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) during screening and within 48 hours prior to the first dose of nivolumab.\n  * WOCBP and men who are sexually active with WOCBP must use adequate contraception (e.g., hormonal or 2 barrier methods with a failure rate of less than 1% per year or abstinence) prior to study entry and throughout study drug administration. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 weeks after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product.\n  * Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception).\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), and who is not postmenopausal. Post menopause is defined as:\n\n    1. Amenorrhea \\>= 12 consecutive months without another cause, and a documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL or\n    2. Women with irregular menstrual periods and a documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL or NOTE: FSH level testing is not required for women \\>= 62 years old with amenorrhea of \\>= 1 year\n    3. Women on hormone replacement therapy (HRT)\n* Pregnant women are excluded from this study because nivolumab is an IgG monoclonal antibody with the potential for teratogenic or abortifacient effects.\n* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nivolumab, nursing should be discontinued if the mother is treated with nivolumab.\n* Ability of subject or Legally Authorized Representative (LAR) to understand and sign the written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Subjects who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab.\n* Subjects with second malignancies requiring active systemic therapy are excluded. Subjects with second malignancies not requiring active systemic therapy or pre-malignant conditions such as monoclonal B-cell lymphocytosis (MBL) or monoclonal gammopathy of undetermined significance (MGUS) may be eligible.\n* Subjects with any condition or autoimmune disease that requires systemic corticosteroids (\\> 10 mg daily prednisone equivalents) or immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted.\n* Subjects with active graft-vs-host disease (GVHD) requiring steroids or other immunosuppressive agents; history of \\>=grade II acute GVHD or extensive chronic GVHD.\n* Subjects who have had solid organ transplant.\n* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti CTLA-4 antibody.\n* Non-oncology vaccine therapies for prevention of infectious disease within 4 weeks of study drug administration.\n* A serious uncontrolled medical condition requiring therapy.\n* Seizures disorder not controlled by anti-seizure medications.\n* Subjects with CNS involvement may be included on the study as long as they have not had any seizure activity in past 4 weeks.\n* Hepatitis B virus surface antigen positive.\n* Active Hepatitis C infection with a positive PCR; subjects who are Hepatitis C antibody positive and PCR negative may be eligible. In these cases, the subjects will be monitored via HCV PCR throughout the study.\n* History of anaphylactic reaction to monoclonal antibody therapy.\n* HIV positive subjects are excluded because the function of their T-cell immune responses is impaired.","12 Years",{"count":84,"type":22},[25],"Background:\n\nThe drug Nivolumab has been approved to treat some cancers. Researchers want to see if it can slow the growth of other cancers. They want to study its effects on cancers that may have not responded to chemotherapy or other treatments.\n\nObjectives:\n\nTo see if Nivolumab slows the growth of some types of cancer or stops them from getting worse. To test the safety of the drug.\n\nEligibility:\n\nPeople 12 and older who have Epstein-Barr Virus (EBV)-positive lymphoproliferative disorders or EBV-positive non-Hodgkin lymphomas with no standard therapy\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nCAT scan of the chest, abdomen, and pelvis\n\nTumor and bone marrow biopsies (sample taken)\n\nMagnetic resonance imaging scan of the brain\n\nLumbar puncture (also known as spinal tap)\n\nPositron emission tomography\u002Fcomputed tomography scan with a radioactive tracer\n\nEvery 2 weeks, participants will get Nivolumab by vein over about 1 hour. They will also have:\n\nPhysical exam\n\nBlood and pregnancy tests\n\nReview of side effects and medications\n\nDuring the study, participants will repeat most of the screening tests. They may also have other biopsies.\n\nAfter stopping treatment, participants will have a visit every 3 months for 1 year. Then they will have a visit every 6 months for years 2-5, and then once a year. They will have a physical exam and blood tests.",[170,31,171,172],"Epstein-Barr Virus Infections","Lymphoproliferative Disorder","Disorders, Lymphoproliferative",[174],"Monoclonal Antibody",{"date":97,"type":41},{"date":177,"type":41},"2018-04-26",{"date":179,"type":22},"2031-06-01",{"name":47,"class":48},{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":23,"phases":191,"briefSummary":193,"conditions":194,"keywords":198,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":49},"100302934","phase-1-venetoclax-ibrutinib-prednisone-obinutuzumab-and-revlimid-vipor-in-relapsedrefractory-b-cell-lymphoma-100302934","NCT03223610","Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed\u002FRefractory B-cell Lymphoma","Phase 1b\u002F2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed\u002FRefractory B-cell Lymphoma","* INCLUSION CRITERIA:\n* Patients must have histologically or cytologically confirmed B-cell lymphoma confirmed by the Laboratory of Pathology, NCI, as follows:\n\nPhase1b\n\n* Aggressive B-cell lymphoma: includes DLBCL and subtypes, transformed lymphoma, Burkitt lymphoma, as well as High-grade B-cell lymphoma with MYC and\u002For BCL2 and\u002For BCL6 rearrangement(s).\n\n  -Indolent B-cell lymphoma:\n* CLL\u002FSLL is excluded given alternative dosing of FDA-approved venetoclax for relapsed 17p CLL and increased risk of TLS with CLL\u002FSLL compared to other non-Hodgkin lymphomas.\n\n  * NOTE: Patients with known active CNS lymphoma are not eligible.\n\nPhase 2\n\n* Relapsed and\u002For refractory DLBCL and subtypes, including transformed lymphoma as well as High grade B-cell lymphoma with MYC and\u002For BCL2 and\u002For BCL6 rearrangement(s).\n* Relapsed and\u002For refractory Follicular lymphoma (FL)\n* Relapsed and\u002For refractory and untreated Mantle cell lymphoma (MCL)\n* Relapsed and\u002For refractory disease on at least 1 prior treatment regimen, as follows:\n\n  * Aggressive B-cell lymphoma:relapsed after and\u002For refractory to at least 1 prior anthracycline-containing regimen\n  * Indolent B-cell lymphoma: relapsed after and\u002For refractory to at least 1 prior anti-CD20 antibody-containing regimen.\n* NOTE: Patients with untreated and relapsed and\u002For refractory MCL will be included in the phase 2 MCL expansion.\n* Patients must have evaluable disease by clinical exam (i.e. palpable lymphadenopathy, measurable skin lesions, etc.), laboratory assessment (i.e. lymphoma involvement of bone marrow or peripheral blood by morphology, cytology or flow cytometry), and\u002For imaging (measurable lymph nodes or masses on CT or MRI and\u002For evaluable FDG-avid lesions on PET).\n* NOTE: Lesions that have been irradiated cannot be included in the tumor assessment unless unequivocal tumor progression has been documented in these lesions after radiation therapy.\n* Age greater than or equal to 18 years\n* NOTE: Because no dosing or adverse event data are currently available on the use of venetoclax in combination with ibrutinib, obinutuzumab, prednisone and Revlimid(R) in patients \\\u003C18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* ECOG performance status less than or equal to 2\n* Adequate organ and marrow function as defined below unless dysfunction is secondary to lymphoma:\n\n  * absolute neutrophil count\\* (\\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters): greater than or equal to 1,000\u002FmcL\n  * hemoglobin\\* (\\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters): greater than or equal to 8 g\u002FdL\n  * platelets greater than or equal to 75,000\u002FmcL\n  * INR: less than or equal to 1.5 X institutional upper limit of normal (ULN) for patients not receiving therapeutic anticoagulation\n  * PTT\u002FaPTT: less than or equal to 1.5 X institutional ULN normal except if, in the opinion of the investigator, the aPTT is elevated because of a positive Lupus Anticoagulant\n  * Total Bilirubin: less than or equal to 1.5 X institutional ULN (or less than or equal to 3 X institutional ULN for patients with documented Gilberts syndrome)\n  * AST(SGOT)\u002FALT(SGPT): less than or equal to 2.5 X institutional ULN\n  * Serum Creatinine: less than or equal to 2.0mg\u002FdL OR\n  * Creatinine Clearance: greater than or equal to 60 mL\u002Fmin\u002F1.73 m\\^2 for patients with creatinine levels above 2 mg\u002FdL\n\nCr Cl will be calculated with the use of the 24-hour creatinine clearance or modified Cockcroft-Gault equation (eCCR; with the use of ideal body mass \\[IBM\\] instead of mass):\n\n(140 - Age) x IBM (kg) x \\[0.85 if female\\]\u002F 72 x serum creatinine (mg\u002FdL)\n\n\\*RBC transfusions and use of G-CSF will be allowed in order to meet eligibility parameters.\n\n* Immune-modulating drugs (IMiDs) including Revlimid(R) are known to be teratogenic and potential embryo-fetal harm can be seen with use of venetoclax and ibrutinib. The effects of obinutuzumab on the developing human fetus is unknown. For these reasons, women of child-bearing potential and men must agree to use adequate contraception as described below.\n* For women of childbearing potential:\n\n  * Agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year as outlined below.\n  * Female subjects of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU\u002FmL within 10-14 days and again within 24 hours prior to prescribing Revlimid(R) for Cycle 1 (prescriptions must be filled within 7 days as required by Revlimid REMS(TM) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking Revlimid(R). FCBP must also agree to ongoing pregnancy testing.\n  * A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (greater than or equal to 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n  * Examples of contraceptive methods with a failure rate of less than 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n* For men:\n\n  * Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n  * With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of less than 1% per year as noted below. Men must refrain from donating sperm during this same period.\n  * With pregnant female partners, men must remain abstinent or use a condom as noted below to avoid exposing the embryo.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n* Contraception Requirements:\n\nPre-Treatment\u002FDuring Treatment:\n\n--All Drugs- Women- begins 28 days prior to treatment; Men- Begins on day 1\n\nPost-Treatment:\n\n* Venetoclax- Women- 90 days; Men 90 days\n* Ibrutinib- Women- 3 months; Men- 3 months\n* Obinutuzumab- Women- 18 months; Men- 6 months\n* Revlimid- Women-28 days; Men- 28 days\n\n  * All study participants must be registered into the mandatory Revlimid REMS(TM) program and be willing and able to comply with the requirements of Revlimid REMS(TM). NOTE: Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS(TM) program\n  * Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nThe following restrictions apply to current or prior anti-cancer treatment, prior to the first dose of study drug:\n\n* Patients who are actively receiving any other investigational agents.\n* Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks prior to the first dose of study drug\n* Radio- or toxin-immunoconjugates within 10 weeks prior to the first dose of study drug\n* Previous treatment with greater than one of the study agents (i.e., venetoclax, ibrutinib or Revlimid(R)), excluding prior prednisone or anti-CD20 antibody treatment\n* Prior allogeneic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug\n* Not recovered (i.e., less than or equal to Grade 1 or baseline) from adverse events due to previously administered anti-cancer treatment, surgery, or procedure. NOTE: Exceptions to this include events not considered to place the subject at unacceptable risk of participation in the opinion of the PI (e.g., alopecia).\n\n  * Patients requiring the use of warfarin are excluded because of potential drug-drug interactions that may potentially increase the exposure of warfarin.\n  * Patients requiring the following agents within 7 days prior to the first dose of venetoclax are excluded:\n* Strong CYP3A inhibitors\n* Strong CYP3A inducers\n\nNOTE: Moderate CYP3A inhibitors and inducers should be used with caution and an alternative medication used, whenever possible.\n\nUncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient at the discretion of the investigator:\n\n* Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia\n* Uncontrolled and\u002For symptomatic thyroid disease\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to Cycle 1, Day 1;\n* Known infection with human T-cell leukemia virus 1 (HTLV-1)\n* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis; as well as active infection with HBV or HCV:\n\n  --Patients who are positive for HCV antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation\n* Patients with occult or prior HBV infection (defined as positive hepatitis B surface antigen (HBsAg) or positive hepatitis B core antibody (HBcAb) with negative HBsAg) may be included if HBV DNA is undetectable. These patients must be willing to undergo HBV DNA testing during treatment and in surveillance for at least 12 months after completion of study therapy.\n* Malabsorption syndrome or other condition that precludes enteral route of administration\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant women, or women who intend to become pregnant during the study, are excluded from this study because Revlimid(R) has known teratogenic effects and venetoclax, ibrutinib and obinutuzumab are agents with 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 these agents, breastfeeding should be discontinued if the mother is treated on study.\n* HIV-positive patients are ineligible because of the potential for pharmacokinetic interactions with venetoclax, ibrutinib and Revlimid(R) and combination antiretroviral therapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.\n* Evidence of active tumor lysis syndrome based on laboratory assessment\n* History of recent major surgery within 6 weeks prior to the start of Cycle 1, Day 1 other than for diagnosis\n* History of other active malignancy that could affect compliance with the protocol or interpretation of results\n\n  * Patients with a history of curatively treated basal or squamous cell carcinoma or stage 1 melanoma of the skin as well as any in situ carcinoma are eligible.\n  * Patients with a malignancy that has been treated with curative intent will also be eligible. Individuals in documented remission without treatment for greater than or equal to 2 years prior to enrollment may be included at the discretion of the investigator.\n* Known allergy to both xanthine oxidase inhibitors and rasburicase; or, known hypersensitivity to any of the study drugs","120 Years",{"count":190,"type":22},155,[192,25],"PHASE1","Background:\n\nB-cell lymphoma is a cancer of white blood cells found in the lymph nodes. It affects the system that fights infections and disease. Researchers want to learn how certain drugs work together to treat B-cell lymphomas. The drugs are venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (ViPOR).\n\nObjective:\n\nTo study the safety of ViPOR for people with B-cell lymphoma.\n\nEligibility:\n\nPeople ages 18 and older with B-cell lymphoma whose cancer has returned or not improved after treatment\n\nDesign:\n\nParticipants will be screened with:\n\n* Medical history\n* Physical exam\n* Blood, urine, and heart tests\n* Tissue sample from previous procedure\n* Imaging scans\n* Registration for counseling on the risks of lenalidomide. They must get counseling at least every 28 days.\n\nParticipants will have a bone marrow aspiration before treatment.\n\nParticipants may have tumor samples taken.\n\nParticipants will get ViPOR in 21-day cycles. For up to 6 cycles:\n\n* Participants will get one drug by IV on days 1 and 2.\n* Participants will take the other four drugs by mouth on most days. After their first dose of venetoclax, they will stay in the clinic for at least 8 hours and return the next day for monitoring. They may be admitted for more drugs or monitoring.\n\nParticipants will keep a drug diary.\n\nParticipants will have a physical exam and blood and urine tests at least once per cycle. They will have scans 4 times over 6 cycles.\n\nParticipants will have a visit about 1 month after their last dose of study drug. They will then have visits every few months for 3 years, and once a year for years 4 and 5. Visits include a physical exam, blood tests, and scans.",[31,195,196,197],"Non-Hodgkin Lymphoma","Diffuse Large B-Cell Lymphoma","Burkitt Lymphoma",[174,199],"Dose-Finding",{"date":97,"type":41},{"date":202,"type":41},"2018-02-09",{"date":204,"type":22},"2027-12-01",{"name":47,"class":48},{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":12,"sex":17,"minAge":213,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":216,"conditions":217,"keywords":222,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":4,"leadSponsor":231,"locationsCount":49},"100166536","collection-of-blood-from-patients-with-cancer-other-tumors-or-tumor-predisposition-syndromes-for-genetic-analysis-100166536","NCT01441089","Collection of Blood From Patients With Cancer, Other Tumors, or Tumor Predisposition Syndromes for Genetic Analysis","Collection of Blood From Therapeutic Trial Participants for Analysis of Genetic Differences in Drug Disposition and Pharmacokinetics of Probe Medications","* INCLUSION CRITERIA:\n* Any individual currently enrolled in an NIH intramural research program clinical trials receiving treatment.\n* Ability of participant or Legally Authorized Representative (LAR) to understand and be willing to sign the informed consent document.\n* Age \\>= 3 years old\n\nEXCLUSION CRITERIA:\n\n-N\u002FA","3 Years",{"count":215,"type":22},1100,"Background:\n\n\\- Some genes may be associated with a greater chance of side effects during cancer treatment. These genes may also make certain treatments less effective. Researchers want to collect blood or cheek swab samples from people having cancer treatment to study these genes.\n\nObjectives:\n\n\\- To obtain a blood or cheek swab sample to study genetic differences that may affect cancer treatment.\n\nEligibility:\n\n\\- Individuals with cancer who are being treated at the National Cancer Institute.\n\nDesign:\n\n* Participants will provide a blood sample for study.\n* Participants who have blood-based cancer, such as leukemia, will provide a cheek swab sample.\n* If the blood or cheek swab sample does not have enough genetic material for analysis, an additional sample may be collected.",[218,219,220,221,31],"Prostate Cancer","Breast Cancer","Lung Cancer","Ovarian Cancer",[223,224,225,226,227,149,89],"Pharmacogenetics","Pharmacokinetics","Pharmacodynamics","Clinical Outcome","Drug Metabolism and Transport",{"date":97,"type":41},{"date":230,"type":41},"2012-05-21",{"name":47,"class":48},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":188,"enrollmentInfo":239,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":241,"conditions":242,"keywords":244,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":49},"100306465","sample-collection-and-tracking-for-the-developmental-therapeutics-clinic-100306465","NCT03269578","Sample Collection and Tracking for the Developmental Therapeutics Clinic","Longitudinal Sample Collection and Tracking for the Developmental Therapeutics Clinic, National Cancer Institute","* INCLUSION CRITERIA:\n* Patients who are being evaluated and\u002For treated for cancer or benign tuumors in the Developmental Therapeutics Clinic at the NIH Clinical Center\n* Ability to understand and willingness to sign a written informed consent document indicating their willingness to have data from their tissue or biologic fluid research specimens and limited medial information used for research as outlined in this protocol and to allow protocol staff access to the CRIS database and their Medical Records Number (MRN).\n* Age greater than or equal to 18 years\n\nECLUSION CRITERIA:\n\nNone",{"count":240,"type":22},3000,"Background:\n\nPeople who join a study in the Developmental Therapeutics Clinic (DTC) have tests. These include blood draws and biopsies. Researchers collect data from these samples. Some people take part in more than one study at the DTC. At this time, data are connected only with one single study. Researchers want to access people s medical records. This will allow them to link the research data from all their studies they have or will take part in. Researchers also want to collect medical data about their diagnosis and treatment history. This will allow them to see how their cancer reacted to different drugs over time.\n\nObjective:\n\nTo enter people into a master protocol to connect research sample and treatment data across DTC studies.\n\nEligibility:\n\nPeople ages 18 and older who are being evaluated or treated for cancer in the DTC\n\nDesign:\n\nParticipants will allow researchers to look at all the data from their research samples. This includes those from their current, past, and any future NIH studies.\n\nParticipants will allow researchers to access some of their medical data. This includes age, diagnosis, treatment history, and response to treatment.\n\nParticipants will provide no new samples.\n\n...",[243,31],"Neoplasms",[225,245,246,247,248,149],"Tissue Collection","Tissue Biopsies","Biospecimen","Assay Development","2026-08-14",{"date":124,"type":41},{"date":252,"type":41},"2017-08-28",{"date":254,"type":22},"2027-05-30",{"name":47,"class":48},{"id":257,"slug":258,"hasResults":12,"nctId":259,"briefTitle":260,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":49},"100532883","phase-2-pilot-trial-of-fecal-microbiota-transplantation-for-lymphoma-patients-receiving-axicabtagene-ciloleucel-therapy-100532883","NCT06218602","Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy.","Inclusion Criteria:\n\n1. At least 18 years of age on the day of signing informed consent.\n2. Histologically\u002Fcytologically confirmed diagnosis of B-cell lymphomas.\n3. Is being planned to received FDA approved standard of care anti-CD19 Axicabtagene Ciloleucel.\n4. Participants must have received or is receiving high-risk broad-spectrum antibiotics for minimum of two days within 180 days of scheduled Axicabtagene ciloleucel infusion. High-risk broad-spectrum antibiotics include carbapenems (meropenem, imipenem, doripenem), anti-pseudomonal antibiotics (cefepime, piperacillin-tazobactam, ceftazidime) or anaerobic antibiotics including metronidazole, clindamycin, amoxicillin-sulbactam.\n5. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Evaluation of ECOG is to be performed within 7 days prior to the date of signing study consent.\n6. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n7. Absolute neutrophil counts should be greater than 1000\u002Ful at the time of administration of fecal enema.\n8. Adequate hepatic function defined by a total bilirubin level ≤ 1.5 ≤ x the upper limit of normal (ULN)\\[except if Gilberts syndrome and then total bilirubin ≤ 3x is allowed\\], an AST, level ≤ 2.5 x ULN, and an ALT level ≤ 2.5 x ULN. If liver metastases are present, then AST and ALT levels must be ≤ 4 x ULN\n9. Adequate renal function defined by an estimated creatinine clearance \\>30 mL\u002Fmin according to the Cockcroft-Gault formula or by a creatinine clearance measurement from a 24-hour urine collection.\n10. Highly effective contraception for both male and female subjects if the risk of conception exists. Highly effective contraception must be used 30 days prior to first study-drug administration, for the duration of trial treatment, and for at least for 12 months after treatment for females and 4 months after treatment for males. Should a female patient (or male participant's sexual partner) become pregnant or should either the female patient (or male participant's partner) suspect she is pregnant while the participant's study-participation is ongoing, the treating physician should be informed immediately.\n\nExclusion Criteria:\n\n1. If participant received major surgery within last 4 weeks, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment.\n2. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n3. Has a diagnosis of primary immunodeficiency (excluding IgA deficiency).\n4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the study subject's best interest to participate, in the opinion of the treating investigator.\n5. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n6. Pregnant or nursing women\n7. For women of childbearing age, a serum pregnancy test will be required within 72 hours prior to enrollment. If the serum test is positive, patient will not be allowed to enroll in the trial.\n8. Participants with history of irritable bowel disease and inflammatory bowel disease will be excluded from clinical trial.\n9. Participants with difficulties in oral administration or at risk of aspiration (e.g., neurological issues)",{"count":84,"type":22},[25],"To find out if adding treatment with fecal microbiota transplantation (FMT) is effective at treating gut-related side effects of antibiotic treatment in participants who are receiving standard therapy with anti-CD19 chimeric antigen receptor T-cell (CAR-T cell) therapy.",[31],"2026-08-13",{"date":124,"type":41},{"date":269,"type":41},"2024-02-19",{"date":271,"type":22},"2028-08-01",{"name":273,"class":73},"M.D. Anderson Cancer Center",{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":17,"minAge":281,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":285,"conditions":286,"keywords":289,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":49},"100538863","discovery-evaluating-a-decision-support-tool-for-adults-seen-in-hematologyoncology-clinics-100538863","NCT06296368","DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology\u002FOncology Clinics","DISCOVERY","Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\n1. Written or verbal informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.\n2. Subjects are willing and able to comply with study procedures based on the judgment of the investigator.\n3. Age ≥ 60 years at the time of consent.\n4. New patient to either the hematologic malignancies clinic or the bone marrow transplant\u002Fcellular therapy clinic.\n\nExclusion Criteria\n\nAll subjects meeting any of the exclusion criteria listed below at baseline will be excluded from study participation:\n\n1\\. Dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent or participation in the intervention.","60 Years",{"count":283,"type":22},500,[86],"The purpose of this study is to evaluate whether a novel decision support tool called PRIME (Preference Reporting to Improve Management and Experience), which combines values-elicitation with tailored feedback to patients and providers, improves patient-reported values-concordance of initial treatment decisions compared to usual care.",[287,31,119,30,288],"Hematologic Malignancies","Blood Cancers",[290,291,292],"decision support tool","pragmatic study","best-worst scaling","2026-08-12",{"date":249,"type":41},{"date":296,"type":41},"2024-06-21",{"date":298,"type":22},"2028-09-01",{"name":300,"class":73},"UNC Lineberger Comprehensive Cancer Center",{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":324},"100473396","compassionate-communication-and-advance-care-planning-to-improve-end-of-life-care-in-treatment-of-hematological-disease-act-100473396","NCT05444348","Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)","Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)- a Cluster Randomized Controlled Study","ACT","Inclusion Criteria:\n\nPatients must:\n\n* Be at least 18 years of age\n* Have a diagnosis of one of the following:\n* High-risk myelodysplastic syndrome (MDS) or MDS with overlap of myeloproliferative neoplasms (high-risk MDS\u002FMPN),\n* Acute myeloid leukemia(AML): Age≥80 or in palliative treatment or relapse\n* Lymphoma: Age≥80 or relapse or refractory or palliative treatment\n* Multiple myeloma(MM): Age≥80 or relapsed or refractory\n\nHave limited treatment options. Provide informed consent. Have sufficient Danish skills to complete intervention sessions and data collection\n\nAn informal caregiver is identified by the patient as the primary provider of informal physical, practical or emotional support and must:\n\n* Be at least 18 years of age\n* Be able to accompany patients to intervention appointments\n* Provide informed consent\n* Have sufficient Danish skills to complete intervention sessions and data collection\n\nPhysicians:\n\n* specialized in hematology\n* treating patients with High risk myelodysplastic syndrome, acute myeloid leukemia, lymphoma, or multiple myeloma\n* work at the same department for the entire time of intervention.\n\nNurses:\n\n* treating patients with High-risk myelodysplastic syndrome, acute myeloid leukemia, lymphoma, or multiple myeloma\n* work at the same department for the entire time of intervention.\n\nExclusion Criteria:\n\nPatient and caregiver are excluded if one of them is:\n\n\\- Suffering from a severe psychiatric disorder\n\nPhysicians and nurses:\n\n\\- If they do not meet the inclusion criterion.",{"count":310,"type":22},920,[86],"Patients diagnosed with hematologic cancer are at substantial risk of dying, as 5-year survival among patients with acute myeloid leukemia is 20 % and only every second patient treated for incurable myeloma lives 5 years after date of diagnosis. Nevertheless, many overestimate their prognosis, and value of therapy. Patients with hematological cancers frequently have poor end of life outcomes, such as high treatment activity close to death, where clinical effects are doubtful, and low utilization of palliative care. Prognostic awareness and end of life (EOL) issues have urgency in the communication between patients, their caregiving relatives, and clinicians, in order to avoid futile treatments and suffering at EOL. Inspired by advanced care planning, the investigators developed the concept \"Advance Consultations Concerning participants Life and Treatment\" (ACT) in collaboration with a group consisting of hematologists, nurses, patients, and caregivers. The ACT concept consists of an 8-hour training day for clinicians, clinical tools, system changes, and preparation material for patients and caregivers prior to the consultation. ACT involves patients and caregivers earlier in preparation for life with chronic progressive disease and EOL-decisions, through an intervention based on compassionate communication and early planning of EOL-care. The aim of the study is to investigate the effect of the intervention on use of chemotherapy and quality of EOL-care in patients with hematological malignancy. Based on the results of the completed pilot study, the investigators are planning a nationwide 2-arm cluster randomized controlled trial where 40 physicians and 80 nurses across seven different hematological departments are randomized to either usual care or ACT training and completing ACT conversations. The investigators expect to include a total of 400 patients and their family caregivers. It is hypothesized that the ACT intervention will decrease use of futile chemotherapy, prepare patients and caregivers for difficult end-of-life-decisions, and improve quality of end-of-life care in hematology.",[119,314,31,315],"Myelodysplastic Syndromes","Acute Myeloid Leukemia","2026-08-11",{"date":293,"type":41},{"date":319,"type":41},"2022-08-01",{"date":321,"type":22},"2028-07-01",{"name":323,"class":73},"Christoffer Johansen",7,{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":17,"minAge":165,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":49},"100632395","phase-1-venetoclax-dexamethasone-bortezomib-and-daratumumab-for-the-treatment-of-adolescent-and-young-adults-with-relapsed-or-refractory-t-cell-acute-lymphoblastic-leukemia-and-t-cell-acute-lymphoblastic-lymphoma-100632395","NCT07513129","Venetoclax, Dexamethasone, Bortezomib, and Daratumumab For The Treatment Of Adolescent And Young Adults With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And T-cell Acute Lymphoblastic Lymphoma","A Phase 1 Study Of Venetoclax, Dexamethasone, Bortezomib, And Daratumumab (VDBD) For Adolescent And Young Adult Patients With Relapsed Or Refractory T-Cell Acute Lymphoblastic Leukemia And Lymphomas","Inclusion Criteria:\n\n* Weight must be \\> or = to 40 kg\n* Patients must have histologically or cytologically confirmed relapsed or refractory T-ALL or TLBL.\n* Age ≥ 12 year to ≤ 30 years.\n* Lansky ≥60 for patients \\\u003C16, Karnofsky ≥60 for patients ≥ 16 years of age. (See Appendix I)\n* Baseline ejection fraction must be \\> 40% OR Shortening fraction \\>20%. Either can be used at the investigator's discretion.\n* Adequate hepatic function (direct bilirubin \\\u003C 1.5x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and\u002For ALT \\\u003C 5x ULN unless considered due to leukemic involvement, in which case direct bilirubin \\\u003C 3x ULN or AST and\u002For ALT \\\u003C 10x ULN will be considered eligible.\n* Adequate renal function (calculated creatinine clearance ≥ 30 mL\u002Fmin) unless related to disease as determined by PI.\n* In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 14 days for cytotoxic or non-cytotoxic (immunotherapy agent(s), or an interval of 5 half-lives of the prior therapy (whichever is shorter). Hydroxyurea and\u002For cytarabine (up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the PI.\n* Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted.\n* Patients may have received any of the study agents prior to enrollment in study if not previously provided in study combination.\n* For patients with history or evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.\n\nFor patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of active progression.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better as determined by PI.\n* 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 patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient 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.\n\nExclusion Criteria:\n\n* Patients with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.\n* No investigational or commercial anti-cancer agents or therapies other than those described below may be administered with the intent to treat the patient's malignancy.\n* The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions:\n\n  i. intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia.\n\nPrevious CNS evaluation and intrathecal (IT) chemotherapy administered prior to consent can be considered as the Cycle 1 Day 1 IT chemotherapy, provided it was completed within 7 days of C1D1. ii. use of hydroxyurea or cytarabine for patients with rapidly proliferative disease.\n\niii. use of steroids for treatment of rapidly proliferative disease. iv. Investigational or commercial agent for supportive care may be used in consultation with the treating physician.\n\n* Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n* Patients with severe uncontrolled peripheral neuropathy significantly impairing motor or sensory function.\n* Patients with a concurrent second active malignancy under treatment.\n* Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.\n\nTesting is not required for patients without a known or suspected history.\n\n* Female subjects who are pregnant or breast-feeding.\n* Patient has an infection that is both active and uncontrolled.\n* History of or any concurrent condition, therapy, or laboratory abnormality that in the Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition venetoclax, dexamethasone, bortezomib, daratumumab.","30 Years",{"count":334,"type":22},18,[192],"This is an open-label, single institution, Phase 1 study of Venetoclax, Dexamethasone, Bortezomib, and Daratumumab for adolescent and young adult participants with relapsed or refractory T-ALL or T-LBL",[338,31],"T-cell Acute Lymphoblastic Leukemia","2026-08-10",{"date":293,"type":41},{"date":342,"type":41},"2026-06-05",{"date":344,"type":22},"2031-12-31",{"name":273,"class":73},{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":354,"minAge":213,"maxAge":355,"enrollmentInfo":356,"targetDuration":4,"studyType":143,"phases":4,"briefSummary":358,"conditions":359,"keywords":363,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":376},"100254767","amh-as-a-predictor-of-infertility-risk-in-children-with-cancer-chance-100254767","NCT02595255","AMH as a Predictor of Infertility Risk in Children With Cancer (CHANCE)","Antimüllerian Hormone as a Predictor of Future Infertility Risk in Prepubertal\u002FPubertal Cancer Patients","CHANCE","Inclusion Criteria:\n\n* Patients from 3 to 14 year old included - Belong to one of these 3 groups (modified from Wallace et al, 2005):\n\n  * High risk : Conditioning therapy for bone marrow transplantation or pelvic irradiation\n  * Moderate\u002FLow risk : Pathologies treated with chemotherapy regimen with moderate or low risk of inducing ovarian function insufficiency: AML, osteosarcoma, Ewing sarcoma, neuroblastoma, non-Hodgkin lymphoma, Hodgkin lymphoma, soft tissue sarcoma, ALL, Wilms tumour, retinoblastoma.\n  * No risk (control group) : patients with chronic benign diseases or malignancies who don't receive any chemotherapy or other gonadotoxic treatment.\n\nExclusion Criteria:\n\n* CNS (central nervous system) irradiation, cerebral tumour\n* Current or previous ovarian disease\u002Fsurgery\n* Familial history of premature ovarian failure (no iatrogenic or surgical origins)\n* Previous known severe chronic disease potentially affecting normal growth or puberty (diseases inducing malnutrition, anorexia, genetic\u002Fcongenital disorders as Turner, Kallman, BPES(Blepharophimosis, ptosis, and epicanthus inversus syndrome) syndromes, uncontrolled severe diabetes, Cushing Syndrome, auto-immune diseases, cystic fibrosis, severe renal dysfunction)\n* Genetic\u002Fcongenital disorders inducing mental retardation","FEMALE","14 Years",{"count":357,"type":22},275,"While most of the children spontaneously recover menstruation or experienced normal puberty after chemotherapy, their ovarian reserve may be impaired by treatment inducing future infertility. Fertility preservation is currently proposed for selected prepubertal patients with a high risk of premature ovarian failure after treatment (mostly conditioning regimen for bone marrow transplantation). For patients with low or moderate risks, counselling is very difficult and no fertility preservation procedure is usually proposed for these patients as no marker of the ovarian reserve has been validated in this young population to assess the individual risk.\n\nThe primary objective of the study is to prevent long-term treatment-related infertility by detecting the young patients who normally progressed to menarche but have a reduced ovarian reserve. These patients may benefit from particular follow-up and fertility preservation procedure.",[360,31,361,362],"Fertility Preservation","Pediatrics Cancer","Gonadotropin-releasing Hormone Agonist",[364,365,366,367,368],"chemotherapy","lymphoma","children","fertility","GnRH (gonadotropin-releasing hormone) analogues",{"date":293,"type":41},{"date":371,"type":41},"2014-04",{"date":373,"type":22},"2041-12-31",{"name":375,"class":73},"Erasme University Hospital",8,{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":384,"enrollmentInfo":385,"targetDuration":386,"studyType":143,"phases":4,"briefSummary":387,"conditions":388,"keywords":395,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":49},"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":60,"type":22},"7 Days","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.",[315,389,390,31,119,391,392,393,394],"Acute Lymphoblastic Leukemia","Myelodysplastic Syndrome","Chronic Lymphocytic Leukemia","Neutropenia","ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION","Invasive Fungal Infections",[396,397,398,399,400],"Liposomal Amphotericin B","Antifungal Prophylaxis","Invasive Fungal Disease","Prolonged Neutropenia","Hematological Malignancies","2026-08-08",{"date":266,"type":41},{"date":404,"type":41},"2025-08-01",{"date":406,"type":22},"2026-11-30",{"name":408,"class":73},"Haikou Affiliated Hospital of Central South University Xiangya School of Medicine",{"id":410,"slug":411,"hasResults":12,"nctId":412,"briefTitle":413,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":420,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":49},"100594042","increasing-resiliency-among-early-post-treatment-lymphoma-survivors-100594042","NCT07014293","Increasing Resiliency Among Early Post-Treatment Lymphoma Survivors","Inclusion Criteria:\n\n* English speaking adult (18 years or older at enrollment)\n* At least 6-months post-lymphoma diagnosis and within 2 years of completing active, curative treatment for lymphoma (includes surgery, chemotherapy\u002Fimmunotherapy\u002Fradiation therapy, or other)\n\nExclusion Criteria:\n\n* Active Psychiatric or cognitive comorbidity as determined by site PI or treating clinician\n* Unwilling or unable to participate using telehealth platform",{"count":416,"type":22},254,[86],"The goal of this clinical trial is to learn if a mind body resilience group program can help increase lymphoma survivors' ability to cope with and manage the challenges that come with the transition into early post treatment survivorship.",[31],[421,422,423,424],"coping","psychosocial intervention","survivorship","resilience",{"date":316,"type":41},{"date":427,"type":22},"2026-08-31",{"date":429,"type":22},"2030-07-01",{"name":431,"class":73},"Massachusetts General Hospital",{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":23,"phases":440,"briefSummary":441,"conditions":442,"keywords":443,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":447,"startDateStruct":448,"completionDateStruct":449,"leadSponsor":451,"locationsCount":49},"100593976","a-resilience-based-approach-to-improve-long-term-quality-of-life-in-post-treatment-lymphoma-survivorship-100593976","NCT07013435","A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship","Thriving Beyond Treatment: A Resilience-Based Approach to Improve Long-term Quality of Life in Post-treatment Lymphoma Survivorship.","Inclusion Criteria:\n\n* English or Spanish speaking adults (18+ at time of enrollment)\n* Within 2 years of completing active, curative treatment for lymphoma (includes surgery, chemotherapy, immunotherapy, radiation therapy, or other)\n\nExclusion Criteria:\n\n* Active psychiatric or cognitive comorbidity as determined by the site PI or treating clinician",{"count":416,"type":22},[86],"The goal of this trial is to learn if a resilience intervention can lead to improvements in lymphoma survivors' quality of life.",[31],[444,422,445,446,424],"quality of life","supportive care","cancer survivorship",{"date":316,"type":41},{"date":427,"type":22},{"date":450,"type":22},"2030-08",{"name":431,"class":73},{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":23,"phases":461,"briefSummary":462,"conditions":463,"keywords":465,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":476},"100469168","a-study-of-mosunetuzumab-alone-or-with-zanubrutinib-in-people-with-follicular-lymphoma-100469168","NCT05389293","A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma","An Open-Label, Multicenter, Single-Arm, Sequential Phase-2 Study of Mosunetuzumab Alone or With Zanubrutinib for the Treatment of Patients With Newly Diagnosed Follicular Lymphoma in Need of Systemic Therapy","Inclusion Criteria:\n\n* Signed Informed Consent Form(s)\n* Ability to comply with all the study-related procedures, in the investigator's judgement\n* Age 18 years or older\n* ECOG performance Status of 0, 1, or 2 \\[Appendix 2\\]\n* Untreated histologically documented FL of grade 1, 2, or 3A\n* Stage II bulky (noncontiguous), III, or IV bulky or high burden disease \\[Appendix 3\\]\n* Need of systemic therapy as evidenced by at least one of the following criteria \\[also see Appendix 4\\]:\n\n  * Bulky disease defined as:\n  * Nodal or extranodal mass \\> 7cm in maximum diameter\n  * ≥ 3 nodal or extranodal sites each with a diameter ≥ 3 cm\n  * Presence of any of the following constitutional symptoms:\n  * Fever (\\>38C) of unclear etiology\n  * Night sweats\n  * Weight loss \\>10% within the prior 6 months\n  * Symptomatic splenomegaly\n  * Mass-related symptoms\n  * End-organ damage (e.g., elevated creatinine or elevated liver enzymes) that is clearly related to lymphomatous infiltration in the opinion of the investigator\n  * Any one of the following cytopenias due to lymphoma:\n  * Hemoglobin \\< 10g\u002FdL\n  * Platelets \\<100 x 10\\^9\u002FL\n  * Absolute neutrophil count (ANC) \\< 1.5 x 10\\^9\u002FL\n  * Pleural or peritoneal serous effusion (irrespective of cell content)\n  * Patients with absolute lymphocytosis ≥5,000 cells\u002FµL in the peripheral blood may be allowed to participate after discussion with the study PI\n* Must be considered as a potential candidate for chemoimmunotherapy in the judgement of the treating physician\n* Must have at least one bi-dimensionally measurable lesion (\\>1.5 cm in its largest dimension for nodal lesions, or \\>1.0 cm in its largest dimension for extranodal lesions by computerized tomography \\[CT\\] scan or MRI)\n* Agreement to provide tumor samples as follows:\n\n  * Agreement to undergo biopsy of a safely accessible tumor site per investigator determination prior to the first dose of mosunetuzumab.\n  * Agreement to undergo repeat biopsy of the same tumor site, if safely accessible, or a different safely accessible tumor site, per investigator determination, 14 to 21 days after the first dose of mosunetuzumab.\n  * Patients who are unable or unwilling to undergo either biopsy procedure may be allowed to participate in, or continue with, the study without any penalization after confirmation from the PI. Inability to undergo a new pre-treatment or an on-treatment biopsy are not considered protocol violations.\n* Adequate hepatic function as follows: aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤3 x upper limit of normal (ULN); total bilirubin level ≤1.5 x ULN (except with documented history of Gilbert syndrome)\n* Adequate bone marrow function as follows:\n\n  * Platelet count ≥75 x 10\\^9\u002FL without transfusion within 14 days prior to first dose of mosunetuzumab;\n  * ANC ≥1 x 10\\^9\u002FL\n  * Hemoglobin level ≥9 g\u002FdL without transfusion within 14 days prior to the first dose of mosunetuzumab\n  * Patients who do not meet criteria for bone marrow function due to marrow involvement of lymphoma and\u002For other disease-related cytopenias (e.g., immune thrombocytopenia) may be enrolled into the study after discussion with, and confirmation by the PI.\n* Serum creatinine ≤ULN or estimated creatinine clearance ≥ 45 mL\u002Fmin by Cockcroft-Gault method \\[see Appendix 5\\] or other institutional standard methods (e.g., based on nuclear medicine renal scan)\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of ≤1% per year, and agreement to refrain from donating eggs, during the treatment period and for at least 3 months after the last dose of mosunetuzumab, and 3 months after the last dose of tocilizumab (if applicable), whichever is longer.\n\n  * A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a post-menopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n  * Examples of contraceptive methods with a failure rate of ≤1% per year include bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.Hormonal contraception methods must be supplemented by a barrier method.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse), or use a condom, and agreement to refrain from donating sperm, as defined below:\n\n  * With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 60 days after the last dose of mosunetuzumab and tocilizumab (if applicable) to avoid exposing the embryo. Men must refrain from donating sperm during this same period.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n* Inability to comply with all the study-related procedures, in the investigator's judgement.\n* FL grade 3B or transformed FL\n* Patients not meeting criteria for systemic therapy as outlined in section 6.1 and Appendix 4\n* Patients unfit for chemoimmunotherapy for reasons including, but not limited to, advanced age and medical comorbidities\n* FL presenting with isolated extra-nodal localizations, such as duodenal FL, cutaneous FL or FL of the testis\n* Pediatric FL\n* Prior anti-lymphoma therapy\n* Prior solid organ transplantation\n* Prior allogeneic stem cell transplantation within 5 years of FL diagnosis. Previously transplanted patients must be off all GVHD-related prophylaxis in order to be considered eligible.\n* Current or prior central nervous system (CNS) lymphoma\n* Current or past history of significant CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n\n  * Patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator are allowed\n  * Patients with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications are allowed\n* Significant cardiovascular disease such as New York Heart Association Class III or IV cardiac disease \\[see Appendix 6\\], myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina\n* Significant active pulmonary disease (e.g., bronchospasm or obstructive pulmonary disease)\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to first mosunetuzumab administration\n* Known or suspected chronic active Epstein-Barr Virus infection\n* Serologic or PCR test results indicating acute or chronic HBV infection\n\n  ° Patients whose HBV infection status cannot be determined by serologic test results (www.cdc.gov\u002Fhepatitis\u002Fhbv\u002Fpdfs\u002Fserologicchartv8.pdf) must be negative for HBV by PCR to be eligible for study participation.\n* Acute or chronic HCV infection\n\n  ° Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation.\n* Serologic test results indicating HIV infection\n* Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study\n\n  * Patients must not receive live, attenuated vaccines (e.g., FluMist®) while receiving study treatment or after the last dose until B-cell recovery to the normal ranges. Killed vaccines or toxoids should be given at least 4 weeks prior to the first dose of study treatment to allow development of sufficient immunity.\n  * Inactivated influenza vaccination during influenza season and the COVID-19 vaccination at any time are allowed. Please see section 10.3.2 (permitted concomitant therapy) for additional guidance on SARS-CoV-2 vaccine administration and timing\n  * Investigators should review the vaccination status of potential study patients being considered for this study and follow the U.S. Centers for Disease Control and Prevention guidelines for adult vaccination with any other non-live vaccines intended to prevent infectious diseases prior to study.\n* Pregnant, lactating, or intending to become pregnant during the study or within 3 months after the last dose of mosunetuzumab and 3 months after the last dose of tocilizumab (if applicable)\n\n  ° Women who are not postmenopausal (≥12 months of non-therapy-induced amenorrhea) or surgically sterile (removal of ovaries and\u002For uterus) must have a negative serum pregnancy test result within 14 days prior to initiation of study drug. If a serum pregnancy test has not been performed within 14 days prior to receiving first study treatment, a negative urine pregnancy test result (performed within 7 days prior to study treatment) must be available.\n* Radiation therapy, unless utilized for the sole purpose of acutely controlling symptomatic disease during the screening period. In this case, at least 2 weeks should lapse between the last radiation dose and the first mosunetuzumab administration and the patient must still have measurable disease outside the field of radiation prior to initiation of the study drug\n* Recent major surgery within 4 weeks prior to first mosunetuzumab administration, except protocol-mandated procedures (e.g., tumor biopsies and bone marrow biopsies)\n* History of autoimmune disease, including, but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\n\n  * Patients with a remote history of, or well-controlled autoimmune disease, may be eligible to enroll after discussion with and confirmation by the PI.\n  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study.\n  * Patients with a history of disease-related immune thrombocytopenic purpura or autoimmune hemolytic anemia may be eligible for this study.\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n  * Rash must cover \\<10% of body surface area\n  * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n  * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months.\n* History of known HLH or suspected HLH in the opinion of the investigator\n* History of confirmed progressive multifocal leukoencephalopathy (PML)\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)\n* History of other malignancy, except:\n\n  * Curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, in situ cervical carcinoma, in situ prostatic neoplasia.\n  * A malignancy treated with curative intent and in remission for at least 2 years prior to the first mosunetuzumab administration\n* Receipt of systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment ≤10 mg\u002Fday prednisone or equivalent within 2 weeks prior to first dose of mosunetuzumab. The following is permitted:\n\n  * The use of up to 12 mg\u002Fday dexamethasone for up to 3 days as antiemetic therapy\n  * The use of up to 1mg\u002Fkg of prednisone or equivalent for ≤7 days to control B symptoms\n  * The use of inhaled corticosteroids\n  * The use of mineralocorticoids for management of orthostatic hypotension\n  * The use of physiologic doses of corticosteroids for management of adrenal insufficiency\n  * The use of premedication corticosteroids prior to undergoing contrast-enhanced imaging studies, in patients who are allergic to contrast agents\n* History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment\n* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's or PI's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results\n\nCohort 2 only:\n\n* Requirement fors ongoing treatment with a strong CYP3A inhibitor or inducer (see section 15.2.3.2)\n* History of severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.\n* History of intracranial hemorrhage ≤ 180 days before the first dose of study treatment\n* Inability to swallow capsules clinically significant or gastrointestinal dysfunction such as demonstrated malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery, symptomatic inflammatory bowel disease, or bowel obstruction.\n* Consumption of one or more of the following within 3 days prior to the first dose of zanubrutinib:\n\n  * Grapefruit or grapefruit products\n  * Seville oranges, including marmalade containing Seville oranges\n  * Star fruit (carambola)",{"count":460,"type":22},152,[25],"The purpose of this study is to find out if mosunetuzumab is an effective treatment in people with follicular lymphoma that was recently diagnosed and have not yet received any treatments for their disease.",[464,31],"Follicular Lymphoma",[466,464,31,467,468],"Mosunetuzumab","Memorial Sloan Kettering Cancer Center","22-100","2026-08-07",{"date":339,"type":41},{"date":472,"type":41},"2022-05-27",{"date":474,"type":22},"2027-12",{"name":467,"class":73},9,{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":484,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":476},"100536281","rat-hemato--return-to-work-after-malignant-hemopathy-100536281","NCT06262789","RAT-HEMATO : Return to Work After Malignant Hemopathy","RAT-HEMATO","Inclusion Criteria :\n\n* Patient with hematological malignancy controlled after treatment\n* Induction\u002Fconsolidation chemotherapy completed (excluding maintenance therapy)\n* Patient aged 18 to 55\n* Patient having worked at least 6 months in the 2 years before diagnosis of hematological malignancy\n* Patient who has not yet returned to work since diagnosis of hematological malignancy\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Patient choosing not to return to work\n* Patient not affiliated to a social security system\n* Patient with legal guardian or legal trustee\n* Patient not understanding French\n* Patient with severe cognitive impairment at diagnosis, incompatible with the study","55 Years",{"count":486,"type":22},264,[86],"Return to work (RTW) of patients after cancer treatment has been a topic of growing interest for the past two decades. Advances in cancer care have led to better patient survival, with some cancers considered as chronic or even cured diseases. The return of patients to their \"pre-cancer life\" can thus become an objective. Indeed, RTW after cancer is associated with improved quality of life for patients in several studies (improved financial status, improved social contacts, return of functional abilities and improved self-esteem). However, many difficulties can interfere with RTW. Many factors have been identified: disease, treatment, patient and occupational factors. The feeling of \"return-to-work self-efficacy\" is one of the main psychological determinants and its interest has been recently demonstrated in oncology. It corresponds to a cognitive mechanism based on expectations and\u002For beliefs of an individual about being able to carry out the actions required to achieve a goal, in this case RTW. The majority of studies on RTW concerns solid cancer and are retrospective. Very few studies have focused on hematological malignancies, whose prognosis was, until recently, worse. Moreover, very few interventional studies exist. There is therefore a significant need for prospective studies with appropriate methodological tools to reliably assess the benefit of interventional measures on RTW. The investigators propose to conduct a prospective, comparative, randomized, multicenter study evaluating the impact of an early RTW-consultation in patients who have been treated for a hematological malignancy. The investigators hypothesize that this consultation will improve patients' RTW rates and RTW quality.",[30,31,119],"2026-08-06",{"date":339,"type":41},{"date":493,"type":41},"2024-09-27",{"date":495,"type":22},"2027-09",{"name":497,"class":498},"University Hospital, Angers","OTHER_GOV",{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":23,"phases":508,"briefSummary":510,"conditions":511,"keywords":513,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":49},"100584913","phase-2-comparison-of-atlg-and-atg-for-immune-reconstitution-after-allo-hsct-for-hematologic-malignancy-100584913","NCT06895538","Comparison of ATLG and ATG for Immune Reconstitution After Allo-HSCT for Hematologic Malignancy","An Exploratory, Non-Randomized, Controlled Study of the Effect of Rabbit Anti-Human T-Lymphocyte Immunoglobulin (ATLG) Versus Anti-Thymocyte Immunoglobulin (ATG) on Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematologic Diseases","Inclusion Criteria:\n\n* 1）Age ≧18 years, gender is not limited;\n* 2）Histologically or cytologically confirmed diagnosis of malignant hematologic diseases;\n* 3\\) First time undergoing allogeneic hematopoietic stem cell transplantation;\n* 4\\) ECOG score 0-2;\n* 5\\) Hepatic and renal function, cardiopulmonary function meet the following requirements.\n\n  * Serum creatinine ≤ 1.5 ULN; ②Left ventricular ejection fraction ≥ 45%;\n\n    * Blood oxygen saturation \\>91%;\n\n      * Total bilirubin ≤ 2 × ULN; ALT and AST ≤ 3 × ULN; for ALT and AST abnormalities due to disease (e.g., liver infiltrates or bile duct obstruction), in the judgment of the investigator, the values may be adjusted to ≤ 5 × ULN;\n* 6\\) Expected survival is longer than 12 weeks;\n* 7\\) The subjects will voluntarily and strictly comply with the requirements of the study protocol and will sign a written informed consent form.\n\nExclusion Criteria:\n\n* 1\\) Prior treatment with ATG, ALG, or ATLG drugs within the past six months;\n* 2\\) Allergic to any component of ATLG or ATG;\n* 3\\) Bacterial, viral, parasitic, or mycobacterial infections not adequately controlled by treatment, i.e., inability to undergo hematopoietic stem cell transplantation due to severe infection.\n\n  4\\) Women who are pregnant or breastfeeding, or participants of childbearing potential who are unwilling or unable to use effective methods of contraception; 5) Participants enrolled in another clinical trial (of any investigational drug or device) within 30 days prior to the subject's baseline visit. (Subjects enrolled in observational studies are eligible to participate).\n\n  6\\) Any other circumstance that, in the judgment of the investigator, may interfere with the conduct of the clinical trial and the determination of the results of the trial.",{"count":507,"type":22},24,[25,509],"PHASE3","Allogeneic hematopoietic stem cell transplantation is the only curative treatment for malignant hematologic diseases. However, immune rejection is a major limitation in its application. In the \"Beijing Protocol\", the use of granulocyte colony-stimulating factor (G-CSF) in combination with anti-thymocyte globulin (ATG) can achieve \"everyone has a donor\". The use of ATG, however, can interfere with the recovery of immune function after transplantation, increasing the risk of life-threatening complications such as viral infections or graft-versus-host disease. Rabbit anti-human T-lymphocyte immunoglobulin (ATLG) is currently approved for the prevention of organ transplant rejection, which is produced differently from ATG. Previous studies have shown that transplant preconditioning with ATLG is effective in preventing graft-versus-host disease and even reduces the incidence of cytomegalovirus, etc. after transplantation. In this study, we will prospectively apply containing ATLG in a cohort of allogeneic hematopoietic stem cell transplantation for malignant hematologic diseases and dynamically observe the state of immune reconstitution of patients after transplantation. We will also compare it with a matched cohort of conventional combined ATGs during the same period to explore the impact of ATLG on immune reconstitution after transplantation.",[30,512,31],"MDS",[514,515,516,517],"ATLG","ATG","immune reconstitution","allo-HSCT","2026-08-03",{"date":520,"type":41},"2026-08-05",{"date":522,"type":41},"2025-05-03",{"date":524,"type":22},"2027-02-28",{"name":526,"class":73},"Peking University First Hospital",{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":12,"sex":17,"minAge":535,"maxAge":57,"enrollmentInfo":536,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":539,"conditions":540,"keywords":548,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":569},"100549997","phase-1-phase-i-trial-to-determine-the-dose-and-evaluate-the-pk-and-safety-of-lutetium-lu-177-edotreotide-therapy-in-pediatric-participants-with-sstr-positive-tumors-100549997","NCT06441331","Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors","A Multicenter, Open-label, Interventional Phase I Trial to Determine the Dose and Evaluate the Pharmacokinetics (PK) and Safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as Monotherapy or Following Standard of Care (SoC) for the Treatment of Somatostatin Receptor-positive Tumors in the Pediatric Population (KinLET).","KinLET","Key Inclusion Criteria:\n\n* Participants aged ≥ 2 years and \\\u003C 18 years\n* Confirmed diagnosis somatostatin receptor-positive (SSTR-positive) disease.\n* Tumor which is relapsed or is refractory to at least one line of previous therapy\n* Positive SSTR protein expression confirmed by immunohistochemistry of a tumor histology sample\n* Radioactivity uptake within the primary tumor or metastatic tumor sites measured by locally available SRIs ( 111In-based, 99mTc-based, or 68Ga-based SSTR single-photon emission computed tomography (SPECT)\u002F computed tomography (CT) or positron emission tomography (PET)\u002FCT imaging, which is higher than the liver uptake)\n* Participants must have recovered from the acute treatment related toxicities (defined as ≤ grade 1 if not defined in eligibility criteria, excluding alopecia, stable treated electrolyte abnormalities on replacement and stable treated hypothyroidism) of all prior treatment modality prior to entering this trial\n* In case of sequential treatment followed by SoC or prior therapy, washout period applies before starting targeted RPT\n\nScreening Consent Participant\u002Flegal guardian is willing to sign a screening consent. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines.\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity to Lutetium Lu 177 Edotreotide, DOTA\u002FEdotreotide, or excipients\n* Previous history of acute leukemia unless in remission for at least two years\n* Extensive bone\u002Fbone marrow involvement as per Investigator's judgement unless peripheral blood stem cells (PBSC) are available at a minimum of 2.5x106 CD34+ cells\u002Fkg\n* Patients who have received previous systemic targeted RPT\n* Previous treatment with metaiodobenzyl guanidine (MIBG) if the predicted overall exposure is expected to exceed 2 Gy (gray) to the bone marrow or 23 Gy to the kidney.\n* Previous treatment with external beam radiation therapy (EBRT) if the predicted overall exposure is expected to exceed more than 2 Gy to the bone marrow or 23 Gy to the kidney.\n* Previous treatment with oncologic immune vaccine or CAR-T cell therapy\n* Bulky disease in the CNS\n* Presence of severe renal, hepatic, electrolyte, cardiovascular, or hematological dysfunction\n* Participants who have received a live-attenuated vaccine up to four weeks prior to enrolment\n* Pregnant or breastfeeding women.\n* Other known malignancies.\n* Serious non-malignant disease.","24 Months",{"count":537,"type":22},20,[192],"The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following standard of care (SoC) in participants ≥2 to \\\u003C18 years of age with somatostatin receptor (SSTR)-positive tumors.",[541,542,31,543,544,545,546,547],"Somatostatin Receptor Positive","NETs","Solid Tumor","CNS Tumors","Rhabdomyosarcoma","Peripheral Primitive Neuroectodermal Tumor","GIST",[549,550,551,31,552,553,554,555,556,557,558,559],"Pediatric","CNS tumors","Solid tumors","Somatostatin Receptor (SSTR)-positive Tumors","Lutetium Lu 177 Edotreotide","Targeted RPT","ITM","GEP-NET","Neuroendocrine tumors","Radiopharmaceutical Therapy","Childhood",{"date":561,"type":41},"2026-08-04",{"date":563,"type":41},"2025-09-26",{"date":565,"type":22},"2034-04",{"name":567,"class":568},"ITM Solucin GmbH","INDUSTRY",6,{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":578,"targetDuration":4,"studyType":23,"phases":580,"briefSummary":581,"conditions":582,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":583,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":590},"100522616","phase-3-a-study-to-evaluate-glofitamab-as-a-single-agent-vs-investigators-choice-in-participants-with-relapsedrefractory-mantle-cell-lymphoma-100522616","NCT06084936","A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed\u002FRefractory Mantle Cell Lymphoma","A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma","GLOBRYTE","Inclusion Criteria:\n\n* Life expectancy at least 12 weeks\n* Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry\n* Relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen) disease\n* At least 1 line of prior systemic therapy including a BTK inhibitor and additional systemic therapy option\n* Confirmed availability of tumor tissue, unless deemed unsafe per investigator assessment\n* At least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion, or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Negative HIV test at screening\n* Adequate hematological function\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of tocilizumab, 2 months after the final dose of glofitamab, whichever is longer\n* Leukemic, non-nodal MCL\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products\n* Contraindication to obinutuzumab or rituximab, and either bendamustine or lenalidomide\n* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3\n* Prior treatment with CAR-T cell therapy\n* Treatment with systemic therapy or BTK inhibitors, or any investigational agent for the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is shorter) prior to first study treatment\n* Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma\n* Current or history of CNS disease, such as stroke, epilepisy, CNS vasculitis, or neurodegenerative disease\n* History of other malignancy that could affect compliance with the protocol or interpretation of results\n* Significant or extensive cardiovascular disease\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment\n* Suspected or latent tuberculosis\n* Positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* Known or suspected chronic active Epstein-Barr viral infection (EBV)\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* Known history of progressive multifocal leukoencephalopathy (PML)\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better\n* Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study\n* Prior solid organ transplantation or allogenic stem cell transplant\n* Eligibility for stem cell transplantation (SCT)\n* Active autoimmune disease requiring treatment\n* Prior treatment with systemic immunosuppressive medications within 2 weeks or five half-lives (whichever is shorter) prior to the first dose of study treatment\n* Corticosteroid therapy within 2 weeks prior to first dose of study treatment\n* Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis\n* Clinically significant history of cirrhotic liver disease",{"count":579,"type":22},182,[509],"The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R\u002FR) mantle cell lymphoma (MCL).",[31],{"date":520,"type":41},{"date":585,"type":41},"2023-10-22",{"date":587,"type":22},"2028-03-31",{"name":589,"class":568},"Hoffmann-La Roche",82,{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":597,"enrollmentInfo":598,"targetDuration":4,"studyType":23,"phases":600,"briefSummary":602,"conditions":603,"keywords":604,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":49},"100452353","phase-4-vaccine-responses-in-patients-with-b-cell-malignancies-100452353","NCT05170399","Vaccine Responses in Patients With B Cell Malignancies","* INCLUSION CRITERIA:\n* Diagnosis of CLL, FL, MCL, MZL, NHL NOS or WM\n* Must fulfil one of the following criteria to be enrolled in one study arm per vaccine received:\n\n  1. Patients with CLL AND one of the following:\n\n     i. Arm 1: Must be treatment naive (no prior cancer directed therapy)\n\n     ii. Arm 2: Patients that have received prior cancer directed therapy and are currently not receiving active treatment\n\n     iii. Arm 3: Must be receiving treatment with a BTKi. This arm is not available to patients receiving the HEPLISAV-B vaccine\n\n     iv. Arm 4: Must be receiving treatment with a BTKi for \\>= 6 months prior to vaccination and be willing to hold their treatment for up to 7 weeks around the time of each vaccination. This arm is not available to patients who have had a prior episode of disease flare during periods of drug hold, or for patients with CLL that is actively progressing.\n\n     v. Arm 5: Must be receiving treatment with a BCL-2 inhibitor\n\n     Or\n  2. Patients with FL, MCL, MZL, NHL NOS or WM AND one of the following:\n\n     i. Arm 1: Must currently not be receiving active treatment (treatment na(SqrRoot) ve or previously treated)\n\n     ii. Arm 2: Must be receiving treatment with targeted therapies (e.g. BTKi, BCL-2 inhibitors, PI3K inhibitors, immunomodulatory agents, proteasome inhibitors)\n* If prior exposure to Hepatitis-B vaccination, must have documentation of negative serologic response\n* Age \\>= 18 years\n* Able to comprehend the investigational nature of the protocol and provide informed consent\n\nEXCLUSION CRITERIA:\n\n1. Female patients who are currently pregnant\n2. History of severe allergic reaction to vaccines\n3. Concomitant inherited immunodeficiency\n4. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator s opinion, could compromise the subject s safety or put the study outcomes at undue risk.\n5. Receive cytotoxic chemotherapy within 2 weeks prior to vaccination\n6. Receive intravenous immunoglobulin (IVIG) within 2 months prior to vaccination\n7. Receive anti-CD20 and\u002For anti-CD19 monoclonal antibody therapy within 6 months prior to vaccination\n8. Receive cellular therapy (e.g. CAR-T cells) within 12 months prior to vaccination\n9. History of allogeneic stem cell transplantation","90 Years",{"count":599,"type":22},350,[601],"PHASE4","Background:\n\nPeople with B cell malignancies (blood cancers) often cannot mount a full immune response to infections or certain vaccines. Bruton tyrosine kinase inhibitors (BTKis), which are used to treat blood cancers, may also negatively affect a person s response to certain vaccines. Researchers want to learn more about vaccine responses in people with certain types of blood cancers. The findings may help develop better vaccine strategies for people with these cancers.\n\nObjective:\n\nTo learn how well vaccines work in people who have certain types of blood cancers.\n\nEligibility:\n\nAdults aged 18 years or older who have chronic lymphocytic leukemia (CLL), Waldenstrom macroglobulinemia, or certain non-Hodgkin lymphomas.\n\nDesign:\n\nParticipants will get one or more vaccines for illnesses, such as vaccines for hepatitis B, shingles, pneumonia, and respiratory syncytial virus (RSV). They may get more than 1 type of vaccine during the study. Not all participants will get all vaccines. Some vaccines require 2 doses.\n\nParticipants will give a blood sample before they get each vaccine. About 4 weeks after they finish each vaccine series, they will give another blood sample. Some vaccines require a second dose 3-6 weeks later. For vaccines that require a second dose, participants may also have study procedures at that visit. Participants may have 2 to 3 study visits per vaccine series.\n\nParticipants may receive a booster dose for some vaccines. The booster dose is optional. For this study, a booster means repeating the full vaccine series. Participants who receive a booster may have additional blood samples to measure their vaccine response.\n\nParticipants will have pregnancy tests, if needed.\n\nParticipants with CLL who receive BTKis may be assigned to either continue treatment or pause treatment around the time of vaccination.\n\nParticipants may give follow-up blood samples once a year for up to 5 years after each vaccine series. These blood samples are optional.\n\nParticipation will last for up to 5 years after each vaccine series is received.",[31],[605,606,607,31,608],"CLL","SLL","Booster","Vaccines","2026-08-01",{"date":561,"type":41},{"date":612,"type":41},"2022-09-14",{"date":614,"type":22},"2036-11-15",{"name":616,"class":48},"National Heart, Lung, and Blood Institute (NHLBI)",{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":623,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":23,"phases":627,"briefSummary":628,"conditions":629,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":157},"100589944","mosaic-trial-for-stem-cell-transplant-recipients-100589944","NCT06960993","Mosaic Trial for Stem Cell Transplant Recipients","Mosaic: RCT of a Digital Health Intervention for English- and Spanish-speaking Stem Cell Transplant Recipients","Mosaic","Inclusion Criteria:\n\n* Diagnosed with a hematologic cancer according to medical records\n* Scheduled for or preparing for scheduling of an allogeneic or autologous stem cell transplant at one of our study sites\n* Aged 18 or older (no upper limit)\n* English or Spanish Proficient\n* Interested in using a website to learn about stem cell transplant\n* Ability to understand and willingness to sign an informed consent document and comply with all study procedures\n\nExclusion Criteria:\n\n* Currently participating in a behavioral intervention targeting distress, health-related quality of life, or symptoms\n* Undergoing the first in a planned tandem stem cell transplant\n* Unable to provide meaningful consent (severe cognitive impairment or language difficulties)",{"count":626,"type":22},356,[86],"The goal of this clinical trial is to learn if using an intervention website (Mosaic) improves selected patient-reported outcomes in adult blood cancer patients undergoing allogeneic or autologous stem cell transplant, compared to using an educational website (control group). Patients will be recruited prior to their scheduled transplant, then randomized to use one of these two study websites throughout the study. They will complete five assessments during the study: one before transplant (baseline) and four after transplant (2, 4, 6, and 8 month follow-ups).\n\nThe main questions this trial aims to answer are:\n\n1. Compared to patients using the control group website, do patients using the intervention website report greater improvements in general psychological distress, cancer treatment-related distress, physical symptoms, and health-related quality of life?\n2. Are these benefits at least partially explained by improvements in perceived preparedness, self-efficacy, and approach coping and\u002For reductions in avoidant coping and perceived stress?\n3. Do some patients benefit more from using the intervention website than others? Specifically, we will examine whether patients' primary language (English\u002FSpanish) and their initial psychological distress are related to the benefit they get from using the intervention website. We will also explore effects of sex, race, ethnicity, and transplant type.",[630,631,632,30,31,119,314],"Hematologic Malignancy","Stem Cell Transplant","Bone Marrow Transplant","2026-07-31",{"date":518,"type":41},{"date":636,"type":41},"2025-04-28",{"date":638,"type":22},"2030-02-01",{"name":640,"class":73},"Northwestern University",{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":648,"targetDuration":4,"studyType":23,"phases":649,"briefSummary":651,"conditions":652,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":666,"lastUpdatePostDateStruct":667,"startDateStruct":668,"completionDateStruct":670,"leadSponsor":672,"locationsCount":49},"100638426","early-phase-1-feasibility-study-on-the-effect-of-a-methionine-reduced-diet-on-serum-levels-in-pts-w-solid-tumors-100638426","NCT07628634","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w\u002F Solid Tumors","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors","Inclusion Criteria:\n\n* Age: Subjects must be 18 years of age or older.\n* Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.\n* Life Expectancy: Subjects must have an expected life expectancy of at least 3 months.\n* Performance Status: Subjects must have an ECOG performance status of 0-2.\n* Organ Function: Subjects must have adequate organ function, as determined by the investigator through review of standard labs.\n* Pregnancy and Contraception: Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to study enrollment and must agree to use adequate contraception throughout the study period and for 30 days after the last dose of study treatment. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.\n* Dietary Compliance: Subjects must be willing and able to comply with the methionine-reduced diet as prescribed by the study protocol.\n* Informed Consent: Subjects or Legally Authorized Representatives (LAR) must provide written informed consent prior to any study-specific procedures, indicating that they understand the purpose of the study and are willing to comply with its requirements.\n* Able to receive systemic standard of care cancer therapy.\n\nAdditional criteria specifically for the glioma population:\n\n* Diagnosis: Histopathological proven diagnosis: a) newly diagnosed grade 2-3 glioma or b) all grades for recurrent glioma.\n* Treatment: Subjects must be able to receive radiation therapy and\u002For chemotherapy as a part of their treatment.\n\nExclusion Criteria:\n\n* Brain Metastases: Subjects with uncontrolled or symptomatic brain metastases. Subjects with brain metastases that have been treated, are asymptomatic, and patients who require steroids are eligible.\n* Significant Clinical Illness: Subjects with uncontrolled significant clinical illnesses, including but not limited to: a) Active infections requiring systemic therapy. b) Severe cardiovascular conditions such as recent myocardial infarction (within 6 months), uncontrolled angina, congestive heart failure (NYHA class III or IV), or significant arrhythmias. (c) Uncontrolled diabetes.\n* Significant Amino Acid\u002FMetabolic Illnesses: Subjects with severe or inherited illnesses that affect metabolism of amino acids or disrupt nutrient absorption, including but not limited to: a) Severe liver disease, such as cirrhosis or severe hepatic insufficiency, that may have compromised ability to metabolize amino acids. b) Inherited metabolic disorders, such as homocystinuria or other disorders affecting sulfur amino acid metabolism, that may have potential metabolic imbalances. c) Severe gastrointestinal disorders, such as active inflammatory bowel disease (IBD), short bowel syndrome, or other conditions that significantly impair nutrient absorption, that may lead to nutritional deficiencies and gastrointestinal complications.\n* Recent Surgery: Major surgery within 4 weeks of randomization (biopsies are acceptable per investigator judgement)\n* Concurrent Malignancies: Subjects with another malignancy that requires active treatment during the study period or is expected to interfere with the study intervention.\n* Pregnancy or Lactation: Female subjects who are pregnant or breastfeeding.\n* Malnutrition: Subjects with severe malnutrition or significant nutritional deficiencies per investigator's discretion.\n* Substance Abuse: Subjects with a history of substance abuse or dependency within the past 6 months that, in the opinion of the investigator, would interfere with adherence to study requirements.\n* Subjects with chronic kidney disease with advanced stages 3b or higher.\n* Psychiatric Disorders: Subjects with psychiatric disorders that would interfere with the ability to give informed consent or adhere to study requirements per investigator judgment.\n* Subjects with known allergies or intolerances to low-methionine foods.\n* Subjects with any medical or surgical conditions that, in the opinion of the investigator, would make adherence to the methionine-reduced diet unsafe or impractical.",{"count":7,"type":22},[650],"EARLY_PHASE1","This is a pilot clinical trial determining the effect of a Methionine-reduced diet on serum levels in subjects with solid tumors. These are subjects who will receive systemic standard of care cancer therapy.",[653,654,655,656,657,658,659,660,545,661,662,663,31,664,665],"Adenocarcinoma","Basal Cell Carcinoma","Squamous Cell Carcinoma","Transitional Cell Carcinoma","Ductal Carcinoma","Osteosarcoma","Soft Tissue Sarcoma","Ewing Sarcoma","Leiomyosarcoma","Melanoma","Germ Cell Tumor","Endocrine Tumor","Glioma","2026-07-29",{"date":633,"type":41},{"date":669,"type":41},"2026-05-01",{"date":671,"type":22},"2028-05-01",{"name":673,"class":73},"University of California, Irvine"]