[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-lymphoid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-lymphoid-leukemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,54,96,124,157,183,196,217,242,267,294],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100054010","phase-1-prophylactic-and-therapeutic-dli-x-for-leukemia-relapse-after-hct-100054010",false,"NCT07254793","Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT","A Feasibility\u002FPilot First-in-human Study of Exercise-mobilized NK-enriched Donor Lymphocyte Infusions (DLI-X) to Prevent or Treat Leukemia Relapse After Allogeneic Hematopoietic Cell Transplantation","DLI Recipient Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 0-65 years\n* Diagnosis of acute leukemia (lymphoid, myeloid or undifferentiated) myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) or non-Hodgkin's lymphoma (NHL)\n* Undergoing myeloablative or reduced intensity matched sibling donor (MSD) HCT or haploidentical HCT\n* Have a locally available healthy matched or haploidentical (≥5\u002F10 HLA antigen matched) related donor between 12 and 50 years of age, consented and able to perform the exercise sessions. (see donor inclusion criteria)\n* The familial donors will first complete the fitness evaluation to determine VO2max and peak cycling power and following successful completion of the donor evaluation, the patients willing to participate in the randomized trial will be enrolled.\n\nDLI Donor Inclusion Criteria:\n\n* Matched sibling donor or HLA-haploidentical relatives of the patient, including biological parents, siblings, or children, half-siblings, cousins or aunts and uncles\n* Weight is greater than 30 kg\n* Age 12 and 50 years\n* Ability to undergo phlebotomy\n* Cardiac, renal, pulmonary, and hepatic function within normal limits\n* Complete blood count (CBC) with differential and platelet count within normal limits, and CMP within normal limits as deemed acceptable by the Principal Investigator and provider evaluating donor.\n* The familial donors should be able complete the fitness evaluation to determine VO2max and peak cycling power and following successful completion of the donor evaluation, the patients willing to participate in the randomized trial will be enrolled.\n\nDLI Recipient Exclusion Criteria:\n\n* Acute grade III-IV aGvHD or moderate\u002Fsevere chronic GvHD.\n* Requiring immunosuppression therapy for treatment of GvHD.\n* Co-morbidities: AST\u002FALT greater than 5 x ULN; Bilirubin greater than 2 x ULN; Creatinine greater than 2 x ULN for age or creatinine clearance\u002FGFR \\\u003C40 ml\u002Fmin\u002F1.73m2; Pulmonary function: DLCO less than 40% of normal or O2 Sat less than 92%; Cardiac: left ventricular ejection fraction less than 35%; active infection; HIV positive; Karnofsky score (adults) less than 60% or Lansky score less than 50% (pediatrics)\n* Uncontrolled or severe bacterial, fungal or viral infection.\n* Positive serum or urine pregnancy test for girls post menarche or women of childbearing age.\n* Severe psychiatric illness or mental deficiency making compliance to treatment unlikely and\u002For informed consent impossible.\n* Any reason, at the investigator's discretion, that the participation of the patient in this protocol would not be in patient's best interest, or where the patient would be unable to adhere to the study requirements.\n\nDLI Donor Exclusion Criteria:\n\n* Unable to perform graded exercise test\n* Cardiac or pulmonary disease restricting exercise\n* Positive anti-donor HLA antibody\n* Pregnant or lactating\n* Active infection\n* Positivity for HIV, hepatitis B (HBV), hepatitis C (HCV), human T-cell lymphotropic virus (HTLV-I\u002FII)\n* Severe psychiatric illness or mental deficiency making compliance with donation unlikely and\u002For informed consent impossible.","ALL","65 Years",{"count":19,"type":20},94,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The primary objective of this proposal is to conduct the first-in-human randomized clinical trial evaluating prophylactic DLI-X (pro-DLI-X) for relapse prevention following matched sibling donor (MSD) or haploidentical (haplo) hematopoietic cell transplantation (HCT) in patients with hematologic malignancies. Additionally, the study aims to assess the safety and efficacy of therapeutic DLI-X (t-DLI-X) compared to t-DLI alone in patients with minimal residual disease (MRD+) or overt relapse post-alloHCT. For patients with CD19-positive lymphoid malignancies, the study will incorporate blinatumomab, while those with myeloid or CD19-negative lymphoid malignancies will receive t-DLI-X or t-DLI alone.\n\nWe hypothesize that both pro-DLI-X and t-DLI-X, with or without blinatumomab, will demonstrate safety and superior efficacy by enhancing graft-versus-leukemia (GvL) effects mediated by natural killer (NK) cells, γδ T cells, and CD8+ T cells, while maintaining manageable and treatment-responsive graft-versus-host disease (GvHD).",[26,27,28,29,30,31],"Acute Lymphoid Leukemia","Acute Myeloid Leukemia","Acute Undifferentiated Leukemia (AUL)","Myelodysplastic Syndrome","Chronic Myeloid Leukemia","Non-Hodgkin Lymphoma",[33,34,35,36,37,38,39,40],"Exercise","Donor Lymphocyte Infusion","Allogeneic Hematopoietic Stem Cell Transplantation","Hematologic Malignancies","Matched Sibling Donor","Haploidentical","Hematopoietic Cell Transplantation","DLI-X","NOT_YET_RECRUITING","2026-07-10",{"date":44,"type":45},"2026-07-13","ACTUAL",{"date":47,"type":20},"2026-10-31",{"date":49,"type":20},"2030-06-01",{"name":51,"class":52},"University of Arizona","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":21,"phases":65,"briefSummary":67,"conditions":68,"keywords":79,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":53},"100473255","phase-1-cd19cd22-bicistronic-chimeric-antigen-receptor-car-t-cells-in-children-and-young-adults-with-recurrent-or-refractory-b-cell-malignancies-100473255","NCT05442515","CD19\u002FCD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies","Phase 1\u002F2 Dose Escalation Study of CD19\u002FCD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies","* INCLUSION CRITERIA:\n* Diagnosis\n\n  * Participant must:\n\n    * Have pathology confirmed B cell ALL (not isolated to the testis or CNS), CML with ALL transformation, or high-grade lymphoma (e.g., Burkitt's lymphoma, B-lymphoblastic lymphoma, diffuse large B-cell lymphoma, inclusive of low-grade lymphoma that has transformed to high grade disease); and\n    * Have relapsed or been refractory after at least one standard chemotherapy regimen and at least one salvage treatment. Participants with Philadelphia chromosome + ALL must have failed prior tyrosine kinase inhibitor; and\n    * Be ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have recurred after SCT; and\n    * Be unable to access (in a timely manner), ineligible for, or have relapsed\u002Ffailed after or not responded to a commercially available CD19 CAR T-cell construct; and\n  * Have evidence of at least minimal residual disease or PET-avid disease (lymphoma) at the time of enrollment.\n* CD22\u002FCD19 expression\n\n  * Cohorts A1b, B1b, C2b\n\n    * CD19 must be detected on \\>15% of the malignant cells by immunohistochemistry or \\> 80% by flow cytometry.\n    * CD22 positivity must be confirmed.\n  * Cohorts D1b, 2 B-ALL\n\n    * CD19 or CD22 positivity must be confirmed\n    * Age \\>= 3 years of age and \\\u003C=39 years of age at time of enrollment.\n    * Clinical Performance status: Participants \\>= 16 years of age: Karnofsky \\>= 50%; Participants \\\u003C 16 years of age: Lansky scale \\>= 50%.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>= 750\u002FmcL\\*\n  * platelets \\>= 50,000\u002FmcL\\*\n  * total bilirubin \\\u003C=2 X ULN (except in the case of participants with documented Gilbert's disease \\> 3x ULN)\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C=10 X institutional upper limit of normal\n  * creatinine \\\u003C= the maximum for age listed in the table below OR\n  * measured creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above the max listed below per age.\n\n    * Age (Years) \\\u003C= 5 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 0.8\n    * Age (Years) 6 to \\\u003C= 10 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 1.0\n    * Age (Years) \\>10 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 1.2\n\n      * a participant will not be excluded because of pancytopenia \\>= Grade 3 if it is due to underlying bone marrow involvement by leukemia\n* Central nervous system (CNS) Status\n* Participants with leukemia with CNS 1 and 2 disease are eligible in the absence of exclusion criteria\n* Participants of child-bearing or child-fathering potential must be willing to practice effective birth control from the time of enrollment until 12 months following completion of study treatment for women and for 4 months following completion of study treatment for men.\n* Participants who are breastfeeding or plan to breastfeed must agree to discontinue\u002Fpostpone breastfeeding while on study therapy and until 1 month after the administration of CAR.\n* Cardiac function: Left ventricular ejection fraction \\>= 45% or fractional shortening \\>=28%\n* Pulmonary Function\n\n  * Baseline oxygen saturation \\>92% on room air at rest\n* Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n* Ability and willingness of participant or Legally Authorized Representative (LAR) to co- enroll on 15-C-0028: Follow-up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials.\n\nEXCLUSION CRITERIA:\n\nParticipants meeting any of the following criteria are not eligible for participation in the study:\n\n* Participants with CNS3 disease, progressing neurologic signs\\* of CNS disease, radiologically detected active CNS lymphoma (\\*resolving manifestation or persistent and\u002For irreversible findings from prior CNS involvement (e.g., blindness) is not exclusionary)\n* Hyperleukocytosis (\\>= 50,000 blasts\u002FmicroL)\n* Positive serum or urine beta-HCG pregnancy test performed at screening.\n* Participants will be excluded based on prior therapy if they fail to meet following washout criteria:\n\n  * Therapy: Systemic Chemotherapy, anti-neoplastic agents, antibody- based therapies\n  * Washout\\*: \\>=2 weeks\n  * Exceptions: 6 weeks for clofarabine or nitrosoureas; No washout for prior intrathecal chemotherapy, steroid therapy, hydroxyurea (no dose increases within prior 2 weeks) or ALL maintenance-type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate, or a tyrosine kinase inhibitor for participants with Ph+ ALL) provided there is recovery from any acute toxic effects\n  * Therapy: Radiation\n  * Washout\\*: \\>=3 weeks\n  * Exceptions: No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the participant has measurable\u002Fevaluable disease outside the radiation window\n  * Therapy: Allogeneic Stem Cell Transplant\n  * Washout\\*: \\>= 100 days since SCT; \\>= 30 days since completion of immunosuppression; \\>= 6 weeks since donor lymphocyte infusion (DLI)\n  * Exceptions: Cannot have evidence of active graft-versus-host disease (GVHD) requiring systemic immunosuppression\n  * Therapy: CAR T-Cell Therapy or other Adoptive Cell Therapy\n  * Washout\\*: \\> 30 days post infusion\n\n    * Washout: Time between therapy and apheresis\n* Positive HIV antibodies consistent with active HIV.\n* Positive hepatitis C antibodies or positive Hepatitis B surface antigen (HbsAG) indicative of current\u002Factive HCV\u002FHBV.\n* Active second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and participant is in remission.\n* History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells.\n* Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the participant.","3 Years","39 Years",{"count":64,"type":20},130,[23,66],"PHASE2","Background:\n\nAcute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses.\n\nObjective:\n\nTo test chimeric antigen receptor (CAR) therapy. CARs are genetically modified cells created from each patient s own blood cells. his trial will use a new type of CAR T-cell that is targeting both CD19 and CD22 at the same time. CD19 and CD22 are proteins found on the surface of most types of ALL.\n\nEligibility:\n\nPeople aged 3 to 39 with ALL or related B-cell lymphoma that has not been cured by standard therapy.\n\nDesign:\n\nParticipants will be screened. This will include:\n\nPhysical exam\n\nBlood and urine tests\n\nTests of their lung and heart function\n\nImaging scans\n\nBone marrow biopsy. A large needle will be inserted into the body to draw some tissues from the interior of a bone.\n\nLumbar puncture. A needle will be inserted into the lower back to draw fluid from the area around the spinal cord.\n\nParticipants will undergo apheresis. Their blood will circulate through a machine that separates blood into different parts. The portion containing T cells will be collected; the remaining cells and fluids will be returned to the body. The T cells will be changed in a laboratory to make them better at fighting cancer cells.\n\nParticipants will receive chemotherapy starting 4 or 5 days before the CAR treatment.\n\nParticipants will be admitted to the hospital. Their own modified T cells will be returned to their body.\n\nParticipants will visit the clinic 2 times a week for 28 days after treatment. Follow-up will continue for 15 years....",[69,70,71,72,73,74,75,76,77,78,26],"B-NHL","B-Non Hodgkin Lymphoma","Acute Lymphocytic Leukemia","Acute Lymphoblastic Leukemia","B-precursor ALL","B-All","Lymphoma, Non-Hodgkin","Leukemia, Lymphocytic, B Cell","B-Cell Lymphoma","B-Cell Leukemia",[80,81,82,83,84,74,73,72,71,70],"Philadelphia chromosome + ALL","Lymphoma","CD-22 Expressing Tumor","CD-19 expressing tumor","Adoptive Immunotherapy","RECRUITING","2026-06-30",{"date":88,"type":45},"2026-07-01",{"date":90,"type":45},"2022-12-28",{"date":92,"type":20},"2029-07-01",{"name":94,"class":95},"National Cancer Institute (NCI)","NIH",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":53},"100558474","phase-1-trial-for-patients-w-advanced-hematologic-malignancies-undergoing-allogeneic-hct-100558474","NCT06551584","Trial for Patients w\u002F Advanced Hematologic Malignancies Undergoing Allogeneic HCT","Trial for Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation From an HLA-Mismatched Donor (7\u002F8) With Orca-T","Inclusion Criteria:\n\n1. Eligible diseases:\n\n   * Acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) as defined in Section 6.1.3; with or without the presence of known minimal residual disease, or\n   * Myelodysplasic syndrome (MDS) myelodysplastic syndromes eligible for alloHSCT and\u002For treatment-related MDS \\\u003C10% blasts\n2. Age ≥ 18 and ≤ 70 years at the time of enrollment.\n3. Eligible for myeloablative alloHCT including one of two the myeloablative conditioning regimens (fractionated total body irradiation plus cyclophosphamide or busulfan, fludarabine, and thiotepa)\n4. Has a related or unrelated donor available who is 7\u002F8 match (single allele mismatched) at HLA-A, -B, -C, and -DRB1, all typed using DNA-based high-resolution methods.\n5. Estimated glomerular filtration rate (eGFR) ≥ 50 mL\u002Fminute or creatinine \\\u003C 2 mg\u002FdL.\n6. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA).\n7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%.\n8. Total bilirubin \\\u003C 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included once hemolysis has been excluded).\n9. Ability to understand and the willingness to provide written informed consent.\n10. Negative serum or urine beta-HCG test in females of childbearing potential (FCBP) within 3 weeks of enrollment.\n\n    A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n11. Able to give informed consent. Legal authorized representative (LAR) is permitted if subject is cognitively able to provide verbal assent.\n12. Karnofsky Performance Score ≥70%\n\nExclusion Criteria:\n\n1. Prior allogeneic HCT.\n2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg\u002Fday are allowed.\n3. Planned donor lymphocyte infusion (DLI).\n4. Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy), peri-transplant anti-thymocyte globulin (ATG), or alemtuzumab. For patients that have previously been exposed to a T cell-depleting agent, a 5 half-life washout of the agent must occur prior to planned Day 0 (day of infusion of Orca-T HSPC and Tregs ).\n5. Recipient positive anti-donor HLA antibodies against a mismatched allele in the selected donor determined by either:\n\n   1. Positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing), or\n   2. Presence of anti-donor HLA antibody to any of the following HLA loci: HLA-A, -B, -C, -DRB1, -DQB1, -DQA1, -DPB1, or -DPA1, with mean fluorescence intensity (MFI) \\>1000 by solid phase immunoassay.\n6. Uncontrolled bacterial, viral, or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment including known, active tuberculosis infection.\n7. Seropositive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B sAg, and\u002For Hepatitis C antibody.\n\n   \\*History of hepatitis B or hepatitis C is permitted if viral load is undetectable per quantitative PCR and\u002For NAT. In this case, monitoring for hepatitis B or hepatitis C by PCR at 3, 6, and 12 months is recommended.\n8. Known allergy or hypersensitivity to, or intolerance of, any investigational agent or ingredient therein, or planned GVHD prophylactic medications.\n9. Documented allergy or hypersensitivity to iron dextran or bovine, murine, algal or Streptomyces avidinii proteins.\n10. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment.\n11. Concurrent malignancy diagnosed within 12 months of enrollment, except non-melanoma skin cancers that have been curatively resected.\n12. Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation.\n\n    (FCBP definition: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\n13. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment. History of stroke or pulmonary embolism within 6 months of enrollment.\n14. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the recipient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.","18 Years","70 Years",{"count":106,"type":20},24,[23],"The study goal is to characterize the safety of the combination of Orca-T with dual agent GVHD prophylaxis.",[27,26,110,111],"Mixed Phenotype Acute Leukemia","Myelodysplastic Syndromes",[113,39,114],"Orca-T","Advanced Hematologic Malignancies","2026-06-18",{"date":117,"type":45},"2026-06-23",{"date":119,"type":45},"2025-12-01",{"date":121,"type":20},"2026-12",{"name":123,"class":52},"Stanford University",{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":131,"sex":16,"minAge":132,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":153,"leadSponsor":155,"locationsCount":53},"100643735","strength-training-exercise-in-pediatric-acute-lymphoblastic-leukemia-and-lymphoblastic-lymphoma-step-all-100643735","NCT07634653","Strength Training Exercise in Pediatric Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (STEP-ALL)","STEP-ALL","Inclusion Criteria for children:\n\nAll subjects must meet the following criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. OR Written assent and parental\u002Flegal guardian consent.\n* Age \\>= 6 and \\\u003C =21 years at the time of diagnosis.\n* Newly- diagnosed with one of the following diseases: B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma\n\nExclusion Criteria for children:\n\n* Subjects must not be receiving any investigational or additional anti-cancer medicines during induction.\n* Significant concurrent disease, illness, or psychiatric disorder or social issue that would compromise subject safety or adherence to the protocol treatment or procedures, interfere with consent, study participation, follow-up, or interpretation of the study results.\n\nOptional caregiver participation:\n\nInclusion Criteria :All caregivers must meet the following criteria\n\n* Written informed consent to participate in the caregiver interviews.\n* The caregiver must be a parent or legal guardian ≥ 18 years old, and their child must be \\\u003C18 years",true,"6 Years",{"count":134,"type":20},40,[136],"NA","Acute lymphoblastic leukemia (ALL) is the most common cancer in children and, along with lymphoblastic lymphoma, represents the most common group of childhood lymphoid malignancies. Survival rates have improved over the years, but many children still experience long-term side effects from treatment. These can include tiredness, weak muscles, pain, nerve problems, difficulty moving, and other physical challenges. Many children with ALL are also overweight at diagnosis, and weight gain often continues during treatment. As a result, about half of childhood leukemia survivors have a BMI at or above the 85th percentile.\n\nTreatment decisions are usually based on a child's symptoms and genetic risk factors. However, some risk factors such as physical activity can be modified. Exercise during treatment may help children feel better and may even improve survival. However, research on early symptom tracking and structured exercise during the first phase of chemotherapy is limited, uses different methods, and often does not include reliable patient-reported symptoms.\n\nEffective exercise programs for children with ALL and lymphoblastic lymphoma need to consider the child's age, treatment side effects, motivation, family support, and ways to encourage long-term behavior change. Because children spend little time in the hospital during the induction phase, a mix of in-person and virtual sessions supported by real-time Zoom instruction can make it possible to offer safe and supervised exercise at home.\n\nThis study will use a guided exercise plan that includes tools to track sets, repetitions, intensity, warm-up time, and perceived exertion. These tools help with consistent monitoring and support both patients and caregivers throughout the program. Twenty children newly diagnosed with ALL or lymphoblastic lymphoma who receive standard 3-4 drug induction chemotherapy will be invited to participate. Our goal is to determine whether a 9-week hybrid exercise program, combined with weekly symptom check-ins, is practical and achievable in both hospital and home settings.",[139,140,26,141,72],"Leukemia","Acute Leukemia","Lymphoblastic Lymphoma",[143,144,145,146,147,33,148],"children","pediatric","weight gain","body mass index (BMI)","physical activity","hybrid exercise program","2026-06-08",{"date":151,"type":45},"2026-06-10",{"date":149,"type":20},{"date":154,"type":20},"2028-06-01",{"name":156,"class":52},"UNC Lineberger Comprehensive Cancer Center",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":103,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":166,"phases":4,"briefSummary":167,"conditions":168,"keywords":171,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":53},"100568448","creation-of-a-biocollection-of-patients-with-acute-myeloid-leukemia-aml-or-lymphoid-leukemia-all-or-high-risk-myelodysplastic-syndrome-mds-monitored-at-the-nantes-university-hospital-100568448","NCT06681363","Creation of a Biocollection of Patients With Acute Myeloid Leukemia (AML) or Lymphoid Leukemia (ALL) or High-risk Myelodysplastic Syndrome (MDS) Monitored at the Nantes University Hospital","LANA","Inclusion Criteria:\n\n* Patient of legal age affected by AML, ALL or MDS regardless of the time of treatment\n* Patient who has signed the consent form.\n* Patient affiliated with a social security system.\n\nExclusion Criteria:\n\n* Minor patients.\n* Adults under guardianship.\n* Protected persons",{"count":165,"type":20},1000,"OBSERVATIONAL","The aim of the LANA bio-collection is to collect samples from patients with Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL) or or high-risk myelodysplastic syndrome (MDS) to facilitate access to the leukemic or myelodysplastic cells for the research teams of the National Institute of Health and Medical Research (INSERM). To do this, an additional blood or bone marrow sample to those planned in the context of patient care will be collected after signing consent. These samples will then be sent directly to the INSERM teams for immediate analysis with the aim to conduct research aimed at a better understanding of AML, ALL or MDS and improving treatments",[169,170,26],"Acute Myeloid Leucemia","High-risk Myelodysplastic Syndrome (MDS)",[172,173],"high-risk myelodysplactic syndrome","Acute leukemia","2026-05-26",{"date":176,"type":45},"2026-05-29",{"date":178,"type":45},"2026-05-21",{"date":180,"type":20},"2036-05-21",{"name":182,"class":52},"Nantes University Hospital",{"id":184,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":185,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":24,"conditions":187,"keywords":188,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":195,"locationsCount":53},"100612531",{"count":19,"type":20},[23],[26,27,28,29,30,31],[33,34,35,36,37,38,39,40],"2026-04-01",{"date":191,"type":45},"2026-04-07",{"date":193,"type":20},"2026-05-31",{"date":49,"type":20},{"name":51,"class":52},{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":103,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":21,"phases":205,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":53},"100480428","phase-1-ucd19-car-t-therapy-in-adults-with-b-all-and-mrd-positivity-in-cr1-100480428","NCT05535855","UCD19 CAR T Therapy in Adults With B-ALL and MRD Positivity in CR1","Phase 1\u002F1b Safety and Tolerability Trial of CD19 Directed CAR T Cells in Adult Patients With B-Cell Acute Lymphoblastic Leukemia (B-ALL) With Minimal Residual Disease (MRD) Positivity at First Complete Remission","Inclusion Criteria:\n\n1. Age: ≥ 18 years of age with no upper age limit\n2. ECOG Performance Status ≤ 2\n3. Confirmed B-cell ALL in first complete morphologic remission\n4. MRD positivity as defined by:\n\n   1. For Ph- ALL: \\> 0.01% by FACS or \\> 0 clonal sequences by NGS (clonoSEQ). MRD assessment for eligibility must be at least 28 days after the start of SOC induction therapy. Remission-induction therapy must have consisted of multi-agent chemotherapy (≥ 3 systemic anti-leukemia chemotherapy agents).\n   2. For Ph+ ALL: \\> 0.01% by FACS, \\> 0 clonal sequences by NGS (clonoSEQ), or less than complete molecular remission (undetectable BCR-ABL1 transcripts by RT-PCR assay with sensitivity of at least 1 in 100,000). MRD assessment for eligibility must be at least 57 days after the start of SOC induction therapy. Remission-induction therapy must have consisted of a BCR-ABL1 directed tyrosine kinase inhibitor and at least one other systemic anti-leukemia chemotherapy agent.\n5. Peripheral blood CD3 count must be \\> 0.15 x 106 cells\u002FmL within 21 days prior to proceeding with apheresis.\n6. Toxicities from prior therapy must be stable and recovered to ≤ Grade 2 (exceptions include non-clinically significant toxicities such as alopecia and the organ function definitions provided in inclusion criteria 7).\n7. Adequate organ function as defined by:\n\n   1. Absolute neutrophil count (ANC) ≥ 500\u002FμL.\n   2. Platelet count ≥ 50,000\u002FμL.\n   3. Renal: Either Creatinine ≤ 2 mg\u002FdL OR creatinine clearance (as estimated by Cockcroft Gault equation) ≥ 60 mL\u002Fmin.\n   4. Hepatic: Serum alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤ 2.5 upper limit of normal (ULN).\n   5. Total bilirubin ≤ 1.5 mg\u002FdL, except in subjects with Gilbert's syndrome where a bilirubin \\\u003C 3.0 mg\u002FdL will be acceptable.\n   6. Cardiac: Ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings at the time of screening.\n   7. Pulmonary: No clinically significant pleural effusion.\n\n   i. Baseline oxygen saturation \\> 92% on room air and; ii. Pulmonary Function Test: Diffuse capacity of the lungs for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) are all ≥50% of predicted by spirometry after correcting for hemoglobin.\n8. Females of childbearing potential must have a negative serum pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential).\n9. Subjects of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the UCD19 infusion.\n10. Must be able to give informed consent; subjects unable to give informed consent will not be eligible for this study.\n11. Be able to consent to long-term follow-up protocol (#20-0188).\n\nExclusion Criteria:\n\n1. Previous CAR T therapy.\n2. Relapsed or refractory B-cell acute lymphoblastic leukemia, including patients who have evidence of MRD after having previously documented MRD-negative remission.\n3. Mixed phenotype acute leukemia or Burkitt's lymphoma\n4. Not in hematological remission at time of enrollment (Remission is defined as \\\u003C 5% blasts)\n5. Signs or symptoms of active CNS disease or detectable evidence of CNS disease on MRI at the time of screening. Subjects who have been previously treated for CNS disease but have no evidence of disease at screening are eligible.\n6. History of malignancy unless disease free for at least 3 years. Exceptions include non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast).\n7. Uncontrolled fungal, bacterial, viral, or other infection requiring antimicrobials for management; simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.\n8. Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (hepatitis B surface antigen \\[HBsAg\\] positive) or hepatitis C.\n9. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment or have cardiac atrial or cardiac ventricular lymphoma involvement.\n10. Venous thrombosis or embolism not managed on a stable regimen of anticoagulation.\n11. Any medical condition that in the judgement of the Sponsor is likely to interfere with assessment of safety or efficacy of study treatment.\n12. History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n13. Females planning to become pregnant during the course of the study.\n\nApheresis Eligibility In order to proceed with apheresis, enrolled participants must continue to meet all inclusion criteria within no more than 21 days prior to apheresis, unless otherwise specified.\n\nNote: Disease evaluation to meet inclusion criteria must be completed within 30 days prior to apheresis.\n\nScreening Eligibility In order to proceed, participants must meet all inclusion criteria. Medical history, blood tests, and assessments may be done as standard of care but must be performed within 14 to 30 days prior to enrollment unless otherwise indicated.\n\nLymphodepleting Chemotherapy Eligibility\n\nIn order to proceed with lymphodepleting chemotherapy, enrolled participants must have all assessments below completed, and continue to meet all inclusion criteria within 72 hours of initiation of lymphodepletion, with the following clarifications:\n\n* Disease restaging studies will be performed as clinically indicated but must be within 14 days prior to initiation of lymphodepletion.\n* Peripheral blood for CD3 count must be obtained within 21 days prior to apheresis and, therefore, is not applicable for determining lymphodepleting chemotherapy eligibility.\n* In lieu of exclusion criteria #4, there must be no evidence of rapidly progressive disease prior to LD chemotherapy initiation per Investigator assessment.\n\nBridging disease directed antineoplastic therapy is allowed with progressive disease after enrollment but before initiation of lymphodepleting chemotherapy will be removed from the study.\n\nThe following assessments will be used to confirm that the participant is able to initiate lymphodepleting chemotherapy (within 72 hours of starting chemotherapy):\n\n* Medical history and Baseline Abnormalities\n\n  * Medical history (defined as ongoing medical conditions identified before the subject's first study-specific intervention (i.e., initiation of LD Chemotherapy on Day -5).\n  * Baseline abnormalities refer to abnormal clinical findings (e.g., laboratory values, vital signs, ECG results, etc.) identified before the start of LD Chemotherapy that may or may not be related to the subject's underlying disease.\n  * All medical history and baseline abnormalities should be entered in the eCRF. Events should be assessed within 30 days prior to enrollment until LD Chemotherapy. Grading per CTCAE v5.0 should reflect the patient's status at the time of LD Chemotherapy.\n* Physical exam\n\nUCD19 CAR T Cell Infusion Eligibility\n\nParticipants must meet the following criteria in order for cells to be infused (based on labs obtained within 24 hours of cell infusion):\n\n* UCD19 CAR T Cells must have met release criteria.\n* Performance status determination (ECOG must be ≤ 2).\n* Participant remains clinically stable without evidence of vital sign instability.\n* Must not have ALT\u002FSGPT and AST\u002FSGOT \\> 10x the ULN or bilirubin \\>2x the ULN, (unless history of Gilberts syndrome where bilirubin must not be \\>3x ULN).\n* Adequate renal function as defined in the Inclusion Criteria.\n* No evidence of uncontrolled infection within 48 hours prior to cell infusion as determined by the PI or sub-investigator. If these criteria are not met, measures will be taken to resolve the underlying condition(s). If successful, cells may be infused up to (and including) 7 days following the time of the planned infusion with no additional lymphodepletion. If the UCD19 CAR T Cell infusion is delayed greater than 7 days, lymphodepleting chemotherapy MAY be repeated. Prior to commencing a second round of lymphodepletion, participants must meet lymphodepletion criteria described above.\n\nPrior to moving to the treatment portion of this study, participants must meet limited eligibility criteria as specified above.\n\nUCD19 CAR T cells may be infused on an inpatient or outpatient basis at the discretion of the treating investigator. Following discharge, participants will continue with once-a-week evaluation until Day 42. If UCD19 CAR T cells are infused on an outpatient basis or following discharge after being inpatient, the participant will need to stay within 1 hour of the Anschutz Medical Campus for at least 4 weeks from date of CAR T cell infusion for monitoring by the treating investigator.\n\nTKI Therapy Post ICD19 CAR T Cell Infusion Eligibility\n\nParticipants must meet the following criteria in order to receive TKI therapy:\n\n* Disease classified as Ph+ B-ALL.\n* Must be past the DLT period (Day 42).\n* Platelet count \\> 50,000\u002FμL.\n* ANC \\> 1000\u002FμL.",{"count":204,"type":20},29,[23],"This open-label, single arm Phase 1\u002F1b trial aims to determine the safety and tolerability of anti-CD19 chimeric antigen receptor-expressing (CAR) T cells (UCD19 CAR T) in adults with B-ALL that are in first complete remission with MRD positivity. This trial will enroll 10 patients during Phase 1 for apheresis, treatment with lymphodepleting chemotherapy, and UCD19 CAR T cell infusion. Patients will be assessed for DLTs (within 42 days after CAR T infusion) to determine a maximum tolerated dose (MTD), duration of B cell aplasia, overall response rate (at 1-3-, 6- and 12-months), and overall survival and event free survival (at 12- and 24- months) post UCD19 CAR T infusion.\n\nAfter the initial dose escalation phase, an additional 12 participants will be enrolled in the dose expansion at the MTD to determine preliminary efficacy.",[26,72],"2026-03-09",{"date":210,"type":45},"2026-03-11",{"date":212,"type":45},"2024-01-24",{"date":214,"type":20},"2030-06-30",{"name":216,"class":52},"University of Colorado, Denver",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":131,"sex":16,"minAge":225,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":21,"phases":228,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":241},"100500111","study-of-the-medullary-microenvironment-in-acute-childhood-leukemia-100500111","NCT05792007","Study of the Medullary Microenvironment in Acute Childhood Leukemia","Etude du Microenvironnement médullaire Dans Les Leucémies Aiguës de l'Enfant","MILA","Inclusion Criteria:\n\n* for patients with AL:\n\n  1. Child with acute lymphoblastic or myeloblastic leukemia at diagnosis\n  2. Not having received prior hematological treatment\n  3. Aged 1 to 15 years old\n  4. Whose 2 parents, or the holder of parental authority, have signed a consent enlightened.\n  5. Affiliated patient or beneficiary of a social security scheme.\n* Control group patients:\n\n  1. Child undergoing orthopedic surgery exposing the bone marrow (osteotomy of the pelvis).\n  2. Aged between 1 and 15 years old.\n  3. Having no pathology of hematological origin.\n  4. Not having received any treatment that could interfere with the functioning of the bone marrow.\n  5. Whose 2 parents or the holder of parental authority have signed a consent enlightened.\n  6. Affiliated patient or beneficiary of a social security scheme.\n\nExclusion Criteria:\n\n* for patients with AL:\n\n  1. Patient under 1 year old and over 15 years old.\n  2. Contraindication to myelogram.\n  3. Absence of signature of the informed consent by the 2 parents or the holder of parental authority.\n  4. Patients with relapsed acute lymphoblastic or myeloblastic leukemia.\n  5. Having received prior hematological treatments.\n  6. Parents with physical or mental condition not allowing to understand the informed consent.\n* Control group patients\n\n  1. Patient under 1 year old and over 15 years old.\n  2. Having an underlying haematological pathology.\n  3. Absence of signature of the informed consent by the 2 parents or the holder of parental authority.\n  4. Having received prior hematological treatments.\n  5. Parents with physical or mental condition not allowing to understand informed consent.","1 Year","15 Years",{"count":134,"type":20},[136],"Acute leukemia (AL) is the most common cancer in children. Despite the optimization of chemotherapy treatments and the development of supportive care, a certain number of LAs relapse and\u002For progress to death of the child. It therefore seems essential to try to better understand the physiopathology and the mechanisms of resistance to treatment of these diseases.",[26,231],"Acute Myeloid Leukemia in Children","2025-11-18",{"date":234,"type":45},"2025-11-24",{"date":236,"type":45},"2023-10-26",{"date":238,"type":20},"2028-10-24",{"name":240,"class":52},"University Hospital, Tours",3,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":225,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":21,"phases":252,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":266},"100502845","phase-2-evaluation-of-treatment-efficacy-according-to-risk-group-in-relapsed-childhood-acute-lymphoblastic-leukemia-100502845","NCT05827549","Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia","ReCALL","Inclusion Criteria:\n\n* Patients \\\u003C= 1 year and \\>22 years of age at the time of relapse will be eligible\n* Participants must have a histologic diagnosis of acute lymphoblastic leukemia:\n\n  * B-ALL: Precursor B-cell acute lymphoblastic leukemia\n  * T-ALL: Precursor T-cell acute lymphoblastic leukemia\n* 1st recurred acute lymphoblastic leukemia patients, recurred parts including marrow. Enrolling patients with combined extra medullary relapse including bone marrow is acceptable. (No limits for extra medullary site) Additionally, subjects whose blast cells in bone marrow are less than 5% (ALL whether type M2 or M3 must be definite)\n* Patients who have never received allogeneic stem cell transplant\n* Patients who have never received blinatumomab before\n* Adequate Renal Function\n\n  -A serum creatinine based on age\u002Fgender as follows:\n\n  1 to \\< 2 years - Male (0.6) Female (0.6) 2 to \\< 6 years - Male (0.8) Female (0.8) 6 to \\< 10 years - Male (1) Female (1) 10 to \\< 13 years - Male (1.2) Female (1.2) 13 to \\< 16 years - Male (1.5) Female (1.4)\n\n  ≥ 16 years - Male (1.7) Female (1.4)\n* Adequate Liver Function defined as a direct bilirubin \\<3.0 mg\u002FdL\n* Adequate Cardiac Function defined as: Shortening fraction of ≥ 27% by echocardiogram, or Ejection fraction of ≥ 50% by echocardiogram\n* Lansky (age \\< 16 years) or Karnofsky (age ≥ 16 years) performance status ≥ 60% at screening\n* Patients with a life expectancy of 1 or more year\n* Patients who are expected to comply with all required study procedures and follow the study protocol in the opinion of the investigator\n* Signed written informed consent and assent forms must be obtained prior to any study procedures\n\nExclusion Criteria:\n\n* Patients with Burkitt leukemia\u002Flymphoma or mature B-cell leukemia\n* Patients with Philadelphia chromosome positive (Ph+) ALL\n* Patients with CD19-negative recurrent progenitor B-cell acute lymphoblastic leukemia (non-expression of CD19 in peripheral blood or bone marrow by flow cytometry) are not eligible for administration of Blinatumomab\n* In case of relapsed within 1 month after the end of induction with the same 4-drug therapy used in this study\n* Patients with mixed phenotype leukemia\n* patient who was relapsed within 1 month after the end of induction therapy with the same 4-drug regimen to be used in this study.\n* Patients with genetic syndrome: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome bone marrow failure syndrome\n* Patients with known HIV\n* Female patients who are not proved as infertile or pregnant (Evidence of infertility: History taking of possibilities of pregnancy or urine human chorionic gonadotrophin test negative, amenorrhea more than a year, Natural or artificial (Ex.hormone therapy) menopause status more than a year, surgical sterilization(Ex.Hysterectomy or ovariotomy etc)\n* Currently receiving treatment in another investigational drug study or clinical trial\n* Evidence of unstable conditions that would pose a risk to subject safety or interfere with the patients\\' compliance\n* Patients with clinically relevant central nervous system (CNS) pathology or active CNS involvement including: unstable epilepsy, uncontrolled seizure, paralysis, aphasia, history of severe brain injury, cerebellar disease, organic brain syndrome, psychosis, coordination\u002Fmovement disorder\n* Known hypersensitivity to drugs or components to be administered: Idarubicin, Etoposide, Ifosfamide, Cytarabine, Vincristine, Mercaptopurine, Blinatumomab","22 Years",{"count":251,"type":20},90,[66],"This study is open-label, multi-center, prospective study, which targets childhood patients with relapsed acute lymphostatic leukemia including bone marrow recurrence. Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for relapsed acute lymphoblastic leukemia in children and adolescents.",[26],[256],"combination chemotherapy","2025-06-04",{"date":259,"type":45},"2025-06-06",{"date":261,"type":45},"2024-04-04",{"date":263,"type":20},"2032-12-31",{"name":265,"class":52},"Ho Joon Im",7,{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":16,"minAge":275,"maxAge":276,"enrollmentInfo":277,"targetDuration":279,"studyType":166,"phases":4,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":53},"100512997","adult-acute-lymphoblastic-leukemia-treated-with-pediatric-regimen-in-brazil-100512997","NCT05959720","Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil","Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study","BRALLA","Inclusion Criteria: Patients between 16 and 50 years-old with newly diagnosed ALL, negative for Philadelphia chromosome not previously treated (except for hydroxyurea, corticosteroids, or intrathecal chemotherapy) with 20% or more lymphoblasts in bone marrow or peripheral blood.\n\nExclusion Criteria:\n\n* Burkitt leukemia\n* Prior myeloproliferative disease\n* Philadelphia chromosome positivity through whichever methodology (RT-PCR, FISH, or conventional karyotype)\n* ECOG\\>2 (appendix 3)\n* Total bilirubin\\>2x upper limit of normal (ULN)\n* Transaminases\\>5x ULN\n* Creatinine\\>2,5 mg\u002Fdl\n* Positive serology for HIV or HTLV\n* Heart failure NYHA Class III or IV (appendix 4)\n* Severe psychiatric disorder which prevents adequate compliance\n* Prior treatment with intravenous chemotherapy\n* Refusal to participate in the study\n* Down syndrome","16 Years","50 Years",{"count":278,"type":20},180,"2 Years","In this project, the investigators intend to start a prospective registry for patients with newly diagnosed Philadelphia-negative ALL from 16 years old and above in participating centers, provided that all patients will be treated with the same regimen (a pediatric regimen BFM-based incorporating peg-asparaginase). All diagnostic\u002Ffollow-up (after induction and consolidation blocks) samples will be centrally biobanked at Instituto do Cancer do Estado de Sao Paulo. The main goal of this study is to examine whether the implementation of a pediatric protocol under a prospective registry can increase event-free survival (EFS) and overall survival (OS) of newly diagnosed patients in the participating centers.",[26,282,283,284],"Minimal Residual Disease","Gene Abnormality","Chemotherapeutic Toxicity","2025-05-03",{"date":287,"type":45},"2025-05-07",{"date":289,"type":45},"2023-09-05",{"date":291,"type":20},"2030-06",{"name":293,"class":52},"Instituto do Cancer do Estado de São Paulo",{"id":295,"slug":296,"hasResults":11,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":16,"minAge":103,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":21,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":312,"locationsCount":53},"100548925","phase-2-phase-ii-study-of-post-transplant-low-dose-inotuzumab-ozogamicin-to-prevent-relapse-of-acute-lymphoblastic-leukemia-100548925","NCT06427330","Phase II Study of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of Acute Lymphoblastic Leukemia","Phase II Study Assessing the Efficacy and Safety of Post-Transplant Low-Dose Inotuzumab Ozogamicin to Prevent Relapse of High Risk Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Diagnosis of CD22-positive Acute Lymphoblastic Leukemia\n* Patients who underwent an allogeneic hematopoietic stem cell transplantation(HSCT) from any donor source or auto-HSCT for acute lymphocytic leukemia\n* Patients who are after T+60 after transplantation\n* Patients who have\u002Fare either:\n\n  * High risk B-ALL: (1) high white blood cell(WBC) count when newly diagnosed, (2) Poor risk group according to NCCN guideline 2021 of Acute Lymphoblastic\n  * Leukemia\n  * Relapsed or refractory to at least 1 line of treatment\n  * Minimal residual disease(MRD) positive before HSCT, including flow cytometry and cytogenetic test\n* Patients who have \\> 99% donor chimerism after allogeneic transplantation.\n* Eastern Cooperative Oncology Group(ECOG) Performance status ≤ 2\n* Participants must have ANC \\> 1,000\u002FµL for 3 days and platelet transfusion independence as defined as a platelet count \\> 50,000\u002FµL for 7 days.\n* ≥ 18 years old, including male and female\n* Participants must have the ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients with evidence of disease progression prior to enrollment\n* Persistent prior treatment toxicities Grade 2 and above according to NCI CTCAE Version 4.03 (with the exception for alopecia, neuropathy, etc.)\n* Patients with inadequate organ function and can't tolerate the study treatment determined by investigator as defined by:\n\n  * Severe renal deficiency, with creatinine clearance \\\u003C 50ml\u002Fmin\n  * Severe hepatic deficiency\n  * Bilirubin, aspartate aminotransferase(AST), and\u002For ALT(ALT) \\> 2X institutional upper limit of normal\n  * Severe cardiac or pulmonary deficiency\n* Graft-versus-host disease(GVHD) grade III or IV (for patients with a prior allogeneic transplant).\n* Active acute or chronic GVHD of the liver (for patients with a prior allogeneic transplant)\n* History of veno-occlusive disease(VOD)\n* Second active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast)\n* Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds",{"count":302,"type":20},21,[66],"To learn about the safety of post-HSCT two dose Inotuzumab Ozogamicin to participants with high risk B cell acute lymphoblastic leukemia(B-ALL). Also, to learn if giving Inotuzumab Ozogamicin to post-HSCT patients with high-risk B- ALL can help to reduce relapse and prolong disease free survival and overall survival.",[26],"2024-07-28",{"date":308,"type":45},"2024-07-30",{"date":310,"type":45},"2024-07-02",{"date":86,"type":20},{"name":313,"class":52},"Institute of Hematology & Blood Diseases Hospital, China"]