[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphoblastic-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphoblastic-lymphoma":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,52,81,117,166,195,226,257,286,319,345,375,403,425,448,497,520,540,563,601,626,655],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100594521","phase-1-a-vaccine-cmv-mva-triplex-vaccine-for-the-enhancement-of-cmv-specific-immunity-and-the-prevention-of-cmv-viremia-in-patients-undergoing-haploidentical-hematopoietic-stem-cell-transplant-100594521",false,"NCT07020533","A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant","A Phase 1b Trial of CMV-MVA Triplex Vaccine in Haploidentical Stem Cell Donors and Recipients to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients of Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n* DONORS: Documented informed consent of the participant. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* DONORS: Age: 18 - 75.\n* DONORS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* DONORS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and for up to 90 days post-vaccination.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n* RECIPIENTS: Documented informed consent of the participant and\u002For legally authorized representative. This can be done in person or informed consent can be obtained remotely.\n\n  * Remote consent, when appropriate, will be obtained per institutional guidelines.\n  * Assent, when appropriate, will be obtained per institutional guidelines.\n  * Adult subjects who require a legally authorized representative (LAR) will not be permitted to be enrolled under this protocol.\n* RECIPIENTS: Participant must be willing to comply with study and\u002For follow-up procedures, including willingness to be followed for one year post-HCT.\n* RECIPIENTS: Age: 18 - 75.\n* RECIPIENTS: Planned peripheral blood stem cell (PBSC) or bone marrow (BM) HCT for the treatment of the following hematologic malignancies:\n\n  * Lymphoma (Hodgkin and Non-Hodgkin).\n  * Myelodysplastic syndrome.\n  * Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia\u002Flymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood. Persistent lymphadenopathy on computed tomography (CT) or CT\u002Fpositron emission tomography(PET) scan without progression is allowed.)\n  * Acute myeloid leukemia in first or second remission.\n  * Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase.\n  * Other hematologic malignancies judged appropriate by the clinical principal investigators (PIs), including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis. Patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded\\*\\*.\n\n    * Adult cases of multiple myeloma (MM) are excluded as HCT is not standard of care for MM and is only performed in very advanced cases with an associated high risk of relapse and non-relapse mortality (NRM). Adults with aplastic anemia are excluded because their standard management includes T cell depletion with agents such as antithymocyte globulin (ATG), which is not permissible on this protocol. Patients undergoing a second haploHCT are not eligible (patients who have undergone a previous autologous HCT are eligible).\n* RECIPIENTS: Patients receiving myeloablative (MA) or reduced intensity conditioning (RIC) are allowed.\n* RECIPIENTS: CMV seropositive.\n* RECIPIENTS: Eligible haploidentical donors will have 2-4 mismatches if human leukocyte antigen (HLA)-A, -B, -C, and -DRB1 typing is used; 2-5 mismatches if HLA-A, -B, -C, -DRB1, and -DQB1 typing is used; and 2-6 mismatches if HLA-A, -B, -C, -DRB1, -DQB1, and -DPB1 typing is used. A unidirectional mismatch in either the graft versus host or host versus graft direction is considered a mismatch. The donor and recipient must demonstrate that they are a full haplotype match by being identical at a minimum of one allele (at high resolution deoxyribonucleic acid \\[DNA\\]-based typing) at the following genetic loci: HLA-A, -B, -C, and DRB1 if 8 allele typing is used; HLA-A, -B, -C, -DRB1, and -DQB1 if 10 allele typing is used; and HLA-A, -B, -C, -DRB1-, DQB1, and -DPB1 is 12 allele typing is used.\n* RECIPIENTS: Planned HCT with minimal to no-T cell depletion of graft.\n* RECIPIENTS: Conditioning and immunosuppressive regimens according to institutional guidelines are permitted.\n* RECIPIENTS: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease) (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Estimated creatinine clearance acceptable per institutional guidelines (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Left ventricular ejection fraction (LVEF) ≥ 50%.\n\n  * Note: To be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and carbon monoxide diffusing capability (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin).\n\n  * If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air.\n  * Note to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combination (combo), hepatitis c virus (HCV)\\*, active hepatitis b virus (HBV) (surface antigen negative) and syphilis (RPR) within 2 months of registration and no history of disseminated cutaneous human papillomavirus (HPV) related disease.\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable.\n* RECIPIENTS: Meets other institutional and federal requirements for infectious disease titer requirements.\n\n  * Note Infectious disease testing to be performed within 45 days prior to day 1 of protocol therapy.\n* RECIPIENTS: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (to be performed within 45 days prior to day 1 of protocol therapy).\n* RECIPIENTS: Agreement by females and males of childbearing potential\\* to use an effective method of birth control (hormonal or barrier method) or abstain from heterosexual activity prior to study entry and up to 90 days post-HCT.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nExclusion Criteria:\n\n* DONORS: Any prior transplant to day 1 of protocol therapy (day 1 defined as the day after donors receive the Triplex vaccine).\n* DONORS: Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy.\n* DONORS: Receipt of any vaccine (licensed or investigational) within 30 days prior to and after the study vaccine.\n* DONORS: Unfit to undergo standard stem cell mobilization and apheresis e.g. abnormal blood counts, history of stroke, uncontrolled hypertension.\n* DONORS: Sickling hemoglobinopathy including hemoglobin (Hb)SS, HbAS, HbSC.\n* DONORS: Donors with impaired cardiac function are excluded. Electrocardiography is routine for potential HCT donors over 60 years old and those with a history of heart disease. Subjects in whom cardiac function is abnormal (excluding 1st degree branch block, sinus bradycardia, sinus tachycardia or non-specific T wave changes) are ineligible for Triplex vaccination.\n* DONORS: Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the donation procedure unlikely and making informed consent impossible.\n* DONORS: Females only: Pregnant or breastfeeding.\n* DONORS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* DONORS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).\n* RECIPIENTS: Any prior investigational CMV vaccine.\n* RECIPIENTS: Experimental anti-CMV chemotherapy in the last 6 months.\n* RECIPIENTS: Live attenuated vaccines (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Medically indicated subunit (Engerix-B for HBV; Gardasil for HPV) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Allergy treatment with antigen injections (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Alemtuzumab or any equivalent in vivo T-cell depleting agent (or CD34+ selection) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)\u002Fvalganciclovir (VAL), foscarnet (FOS), cidofovir, CMX-001, maribavir. Acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment EXCEPT letermovir prophylaxis (prior to day 100) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Disease-based radiation therapy (not total body irradiation) (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other investigational product(s) - concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Other medications that might interfere with the evaluation of the investigational product (planned medications from the time of HCT to day 70 post-HCT).\n* RECIPIENTS: Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years.\n* RECIPIENTS: Patients considered by PI\u002Fconsenting physicians to have a complicated prior therapy or HCT regimen, or who have a low survival probability (e.g., refractory leukemia and\u002For undergoing 2nd HCT).\n* RECIPIENTS: Poor risk disease\u002Fdisease status including: Chronic myelogenous leukemia (CML) in blast crisis, acute myeloid leukemia (AML)\u002Facute lymphoblastic leukemia (ALL) beyond 2nd remission, multiple myeloma, and aplastic anemia.\n* RECIPIENTS: Females only: Pregnant or breastfeeding.\n* RECIPIENTS: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* RECIPIENTS: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",true,"ALL","18 Years","75 Years",{"count":21,"type":22},46,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This phase Ib trial tests the safety, side effects, and how well cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine works in enhancing CMV-specific immunity and preventing CMV viremia in patients undergoing haploidentical hematopoietic stem cell transplant. Haploidentical stem cell transplantation (haploHCT) has advanced to become the predominant procedure for patients lacking a matched donor. Compared to matched related donor transplants, the rate of significant CMV infection is higher in patients undergoing a haploHCT. Significant CMV infection is associated with an increased risk of complications and death. Vaccination is the main preventative approach to limit complications and death in immunocompromised patients at high risk of post-stem cell transplant infections. CMV-MVA Triplex vaccine, is a CMV vaccine based on the attenuated poxvirus, modified vaccinia Ankara (MVA), developed to enhance CMV-specific immunity in both healthy stem cell transplant donors and stem cell transplant patients to prevent significant CMV infection post-stem cell transplant. Giving CMV-MVA triplex vaccine may be safe, tolerable and\u002For effective in enhancing cytomegalovirus (CMV)-specific immunity and preventing CMV viremia in patients undergoing a haploHCT.",[28,29,30,31,32,33,34,35,36,37,38,39],"Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Chronic Lymphocytic Leukemia","Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Hematopoietic and Lymphatic System Neoplasm","Hodgkin Lymphoma","Lymphoblastic Lymphoma","Myelodysplastic Syndrome","Myelofibrosis","Myeloproliferative Neoplasm","Non-Hodgkin Lymphoma","RECRUITING","2026-06-30",{"date":43,"type":44},"2026-07-02","ACTUAL",{"date":41,"type":44},{"date":47,"type":22},"2028-05-30",{"name":49,"class":50},"City of Hope Medical Center","OTHER",3,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100357351","mobile-health-intervention-to-support-oral-chemotherapy-adherence-in-adolescents-and-young-adults-with-leukemia-100357351","NCT03932903","Mobile Health Intervention to Support Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia","Using Real Time Mobile Health Approaches to Understand and Promote Oral Chemotherapy Adherence in Adolescents and Young Adults With Leukemia","AYA Inclusion Criteria:\n\n* Ages 14-29\n* Diagnosed with acute lymphoblastic leukemia (ALL) or lymphoma\n* In the maintenance phase, completed at least one cycle and has at least one month of maintenance therapy remaining.\n* Prescribed 6-mercaptopurine (6MP)\n* English language proficiency\n* For AYA \\<18, must have informed consent from their caregiver.\n\nAYA Exclusion Criteria:\n\n* Cognitive impairments that would limit ability to complete measures, determined by the medical team\n* Absence of inclusion criteria above.\n\nCaregiver Inclusion Criteria:\n\n* Nominated by the AYA as a primary caregiver involved in cancer care (can be a parent, relative, partner, friend)\n* English language proficiency\n\nCaregiver Exclusion Criteria:\n\n\\- Absence of inclusion criteria above.","14 Years",{"count":61,"type":22},60,[63],"NA","This is a small-scale micro-randomized clinical trial of a new mobile just-in-time adaptive intervention (JITAI) designed to promote oral chemotherapy adherence in adolescents and young adults (AYA) with acute lymphoblastic leukemia (ALL). The goals of this study are to determine intervention feasibility and acceptability.",[29,35],[67,68,69,70,71],"Adherence","Adolescent","Young Adult","Mobile Health","Oncology","2026-06-29",{"date":41,"type":44},{"date":75,"type":44},"2025-07-31",{"date":77,"type":22},"2027-08-31",{"name":79,"class":50},"Northwestern University",1,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":93,"conditions":94,"keywords":100,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":80},"100544095","phase-1-anti-cd19-chimeric-antigen-receptor-t-cell-immunotherapy-for-leukemias-100544095","NCT06364423","Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Leukemias","Phase I\u002FII Trial of Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for B-cell Leukemias","* INCLUSION CRITERIA:\n* Malignancy criteria\n\n  * Histologically confirmed participants with either CLL or SLL or B-cell acute lymphoblastic leukemia or lymphoma (ALL) via immunohistochemical or flow cytometry methods will be eligible. Participants with evidence of Richter s transformation of CLL\u002FSLL are also eligible. Participants with Richter s transformation must have current or prior evidence of CLL, confirmed by review of a current or prior histological sample by NIH pathologists or confirmed by flow cytometry performed at the NIH.\n  * Demonstration of CD19 expression on CLL\u002FSLL or ALL, as assessed by the NCI Laboratory of Pathology or NIH Department of Laboratory Medicine Hematopathology section. For participants with pathologically confirmed Richter s transformation, the transformed cells must also have CD19 expression.\n  * CD19 expression must be uniform meaning no populations of clearly CD19-negative CLL\u002FSLL, Richter s or ALL cells are observed.\n  * CD20 must be detected on \\>= 20% of malignant cells by flow cytometry or immunohistochemistry. Documentation of CD20 expression is not required for patients who have received CD20-directed therapy within 90 days prior to the date of enrollment.\n  * The last dosage of systemic therapy (including corticosteroids) must be at least 14 days prior to the first dose of rituximab, with the exceptions of BTK inhibitors (BTKi) for CLL\u002FSLL and tyrosine kinase inhibitors (TKI) for ALL. Participants who were receiving a BTKi for CLL\u002FSLL or a TKI for ALL for at least 14 days prior to protocol enrollment can continue these agents during part of the time the participants are enrolled on this clinical trial.\n  * For participants who have received antibodies targeting CD19, at least sixty days must elapse between therapy with antibodies targeting CD19 and CAR T-cell infusion.\n  * Participants with CLL\u002FSLL must have received at least two prior treatment regimens, at least one of which must have contained a Bruton s tyrosine kinase (BTK) inhibitor. Participants who took a BTK inhibitor but stopped due to intolerance are potentially eligible. Participants with relapsed or refractory CLL\u002FSLL after alloHSCT are eligible.\n  * Participants with refractory ALL that failed induction or participants with relapsed ALL after a standard induction regimen or after any later line of therapy are eligibleParticipants with relapsed or refractory ALL after alloHSCT are eligible.\n  * All participants must have measurable malignancy as defined by at least one of the criteria below.\n\n    * Presence of CLL,SLL, or ALL masses that are measurable (minimum 1.5 cm in largest diameter) by CT scan or PET\u002FCT is required unless bone marrow or blood involvement with malignancy is detected.\n    * For CLL\u002FSLL or ALL with only bone marrow and\u002For blood involvement, no mass is necessary, but if a mass is not present, bone marrow and\u002For blood malignancy must be detectable by flow cytometry. Any level of CLL\u002FSLL or ALL detectable by flow cytometry is sufficient.\n* Other inclusion criteria:\n\n  * Age \\>= 18 years.\n  * Performance status (ECOG) 0-1.\n  * Participants must have adequate organ and marrow function as defined below:\n\n    * ANC \\>= 1,000\u002FmcL without the support of filgrastim or other growth factors in the 10 days prior to screening assessment\n    * platelets \\>= 50,000\u002FmcL without transfusion support\n    * hemoglobin \\>= 8 g\u002FdL\n    * total bilirubin \\\u003C= 2.0 mg\u002FdL\n    * ALT or AST Serum ALT and AST less or equal to 3 times the upper limit of the institutional normal unless liver involvement by malignancy is demonstrated. If liver involvement with malignancy is detected, ALT and AST must be less than or equal to 5 times the upper limit of normal\n    * Serum Creatinine Serum creatinine levels \\\u003C 1.5 X institutional ULN. Participants with serum creatinine \\>= 1.5 X institutional ULN may participate if serum creatinine eGFR is \\>=50 mL\u002Fmin\u002F1.73m\\^2 by 2021 CKD-EPI equation.\n\n      * ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase);\n      * AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n      * (A)Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.\n  * For CLL participants, B cells must make up less than 95% of blood lymphocytes on a lymphocyte phenotyping profile TBNK at the time of screening assessment. For ALL participants, the peripheral blood blast percentage on CBC differential must be 1% or less.\n  * Room air oxygen saturation of 92% or greater\n  * Participants of child-bearing or child-fathering potential must be willing to practice abstinence or highly effective contraception starting at the time of study entry, for the duration of study therapy, and for 12 months after receiving the protocol treatment.\n  * Participants must agree not to donate eggs for 12 months after receiving the protocol treatment\n  * Participants who are breastfeeding must be willing to cease breastfeeding from study treatment initiation through 12 months after the last dose of the study drugs.\n  * Participants must have a negative blood PCR test for hepatitis B DNA. If hepatitis B DNA (PCR) testing is not available, participants must have a negative hepatitis B surface antigen and negative hepatitis B core antibody test.\n  * Participants must have a negative blood PCR test for hepatitis C RNA. Only if Hepatitis C PCR testing is not available in a timely manner, participants must have a negative Hepatitis C antibody test.\n  * Cardiac ejection fraction of greater than or equal to 50% by echocardiography and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram within 30 days prior to treatment start.\n  * All participants must have the ability to understand and willingness to sign a written informed consent.\n  * All participants must be willing to undergo mandatory biopsies during the study.\n\nEXCLUSION CRITERIA:\n\n* Participants who are receiving any other investigational agents.\n* Participants who have had prior CAR T-cell therapy.\n* Participants who have had a live-attenuated or viral vector-based vaccine in the last 60 days prior to pre-leukapheresis rituximab. Participants who plan to receive a live attenuated or viral vector-based vaccine within the first 100 days after CAR T-cell infusion.\n* Participants that require urgent therapy due to tumor mass effects or spinal cord compression.\n* Current\u002Factive HIV infection, as measured by seropositivity for HIV antibody.\n* Participants with second malignancies in addition to their CLL or ALL are not eligible if the second malignancy has required treatment with surgery, radiation or chemotherapy, or other therapies within the past 2 years or is not in complete remission. Exceptions are that, in the last 2 years, participants may have had successful resection of non-metastatic basal cell or squamous cell carcinoma of the skin, and participants may have received hormonal therapy for fully resected breast cancer.\n* Positive beta Human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test in women of childbearing potential (WOCBP) performed at screening.\n* Active uncontrolled systemic infections (defined as infections causing fevers within 48 hours of the date of planned protocol rituximab or chemotherapy start and infections requiring intravenous antibiotics when intravenous antibiotics have been administered for less than 72 hours at the time of protocol rituximab or chemotherapy start). There must be objective evidence of infection, including, but not limited to, a positive blood, urine or sputum culture, positive nasal swab or blood test for viral infection, or the appearance of infiltrates on imaging of the lung.\n* Active coagulation disorders, major uncontrolled medical illnesses of the cardiovascular, respiratory, endocrine, renal, gastrointestinal, genitourinary or immune system, history of myocardial infarction, history of ventricular tachycardia or ventricular fibrillation, active cardiac arrhythmias with the exception of atrial fibrillation with baseline heart rates less than or equal to 90 beats per minute, (Use of medications to control heart rate is allowed.), active obstructive or restrictive pulmonary disease, or active autoimmune diseases such as rheumatoid arthritis. These include uncontrolled intercurrent illness manifesting as electrolyte derangements or as assessed by chemistries.\n* Significant neurologic disorders, including a history of a seizure disorder as an adult, that are not completely and permanently resolved and not requiring current treatment.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease) that has not been cured by a prior allogeneic stem cell transplant.\n* For participants that have not had prior allogeneic stem cell transplant: Systemic corticosteroid steroid therapy of any dose greater than 5 mg\u002Fday or more of prednisone or equivalent is not allowed within 14 days prior to the first dose of rituximab. Corticosteroid creams, ointments, and eye drops are allowed.\n* For participants that have had prior allogeneic stem cell transplant: Receiving any systemic immunosuppressive drugs including corticosteroids at doses of greater than 5 mg\u002Fday prednisone or equivalent within 28 days prior to Rituximab. Topical corticosteroid preparations applied to the skin such as solutions, creams, and ointments are allowed. Inhaled corticosteroids are allowed, and corticosteroid eye drops are allowed.\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study, including hypersensitivity to aminoglycoside antibiotics, which may be used in the cell culture media.\n* Participants with CNS3 disease, neurologic signs of CNS disease, radiologically detected active CNS lymphoma or meningeal involvement.\n* Checkpoint inhibitor drugs such as pembrolizumab or nivolumab or other antibodies targeting PD-1 or PDL-1 within 180 days of pre-leukapheresis rituximab. This is because of possible effects checkpoint inhibitor therapy could have on the participant's T cells.\n* Known active alcohol or drug abuse.\n* History of allergy to study drug components.\n* Active tumor lysis syndrome as assessed by serum uric acid, LDH, calcium, and phosphorus.\n* Active rhabdomyolysis as assessed by elevated CK and acute change in renal function as reflected by increased creatinine and blood urea nitrogen (BUN).\n* Active diabetic ketoacidosis or hyperosmolar hyperglycemic state, as assessed by serum glucose. The urine will be tested for ketones if serum glucose is over 350 mg\u002FdL at screening.\n* Participants who received a previous allogeneic HSCT must have no (grade 0) acute GVHD (Appendix H) and either no chronic GVHD or mild chronic GVHD. Participants with GVHD meeting the above criteria with local therapy (topical cutaneous steroids, inhaled steroids, and eye drops) will be eligible for enrollment.","120 Years",{"count":90,"type":22},132,[25,92],"PHASE2","Background:\n\nChronic lymphocytic leukemia (CLL),small lymphocytic lymphoma (SLL) and B-cell acute lymphoblastic leukemia or lymphoma (ALL) are blood cancers that affect certain white blood cells. Advanced forms of these diseases are difficult to treat. CD19 is a protein often found on the surfaces of these cancer cells. Researchers can modify a person's own immune cells (T cells) to target CD19. When these modified T cells are returned to the body-a treatment called anti-CD19 chimeric antigen receptor (CAR) T cell therapy-they may help kill cancer cells.\n\nObjective:\n\nTo test anti-CD19 CAR T cell therapy in people with CLL or SLL and ALL.\n\nEligibility:\n\nPeople aged 18 years and older with CLL or SLL and ALL that has not been controlled with standard drugs.\n\nDesign:\n\nParticipants will be screened. They will have imaging scans and tests of their heart function. If a sample of tissue from their tumor is not available, a new one may be taken; the sample will be tested for CD19.\n\nParticipants will receive a drug to reduce the leukemia cells in their blood. Then they will undergo apheresis: Blood will be taken from the body through a needle. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different needle. The collected T cells will be gene edited to make them attack cells with CD19.\n\nParticipants will take drugs to prepare them for treatment for 3 days. These drugs will start 5 days before the treatment. Then their own modified CAR T cells will be returned to their bloodstream. Participants will stay in the hospital for at least 9 days after the treatment.\n\nFollow-up visits will continue for 5 years.",[95,96,97,29,35,98,99],"Leukemia, Lymphocytic, Chronic, B-Cell","B-Lymphocytic Leukemia, Chronic","B-Cell Chronic Lymphocytic Leukemia","Leukemia, Acute Lymphoblastic","Small Lymphocytic Lymphoma",[99,101,102,31,103,104,105,106,17,29],"Immunotherapy","CLL","Chimeric Antigen Receptors","Autologous T Cells Infusion","Adoptive T Cell Therapy","CAR","2026-06-23",{"date":109,"type":44},"2026-06-24",{"date":111,"type":44},"2024-09-03",{"date":113,"type":22},"2030-07-01",{"name":115,"class":116},"National Cancer Institute (NCI)","NIH",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":128,"conditions":129,"keywords":152,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":80},"100309946","phase-2-myeloablative-allo-hsct-with-related-or-unrelated-donor-for-heme-disorders-100309946","NCT03314974","Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders","Myeloablative Allogeneic Hematopoietic Cell Transplantation Using a Related or Unrelated Donor for the Treatment of Hematological Diseases","-Inclusion Criteria:\n\n* Age: ≤ 60 years of age\n* Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70\n* Consent: Voluntary written consent (adult or legally authorized representative; or parental\u002Fguardian)\n* Adequate Organ Function:\n\n  * Renal: Creatinine \\\u003C2x upper limit of normal. Patients above this limit must have creatinine clearance ≥ 40 ml\u002Fmin\u002F1.73m2 as determined by an age-appropriate method, such as cystatin C GFR.\n  * Hepatic: Bilirubin, AST, alkaline phosphatase \\\u003C4 times the upper limit of institutional normal\n  * Pulmonary: Diffusion capacity of oxygen, corrected for hemoglobin, \\> 50% of predicted. For pediatric patients not able to undergo PFTs or diffusion testing: O2 sat of \\>95% on room air\n  * Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 45%. For children not able to cooperate with MUGA or echocardiography, such should be clearly stated in the physician's documentation\n  * HIV Status: HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation\n\nOther Inclusion Criteria:\n\n* Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.\n* Donor Availability: Patients considered for transplantation must have a sufficient graft as based on current criteria of the University of Minnesota Blood and Marrow Transplantation Program\n* Eligible Diseases and Status: Patients are eligible unless their treatment is to be guided by a higher priority protocol.\n* Acute Leukemias: Must be in remission by morphology (≤5% blasts). Also a small percentage of blasts that is equivocal between marrow regeneration vs. early relapse are acceptable provided there are no associated cytogenetic markers consistent with relapse.\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms: 2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n* Favorable risk AML is defined as having one of the following:\n\n  * t(8,21) without cKIT mutation\n  * inv(16) or t(16;16) without cKIT mutation\n  * Normal karyotype with mutated NPM1 and wild type FLT-ITD\n  * Normal karyotype with double mutated CEBPA\n  * Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n* Very high risk pediatric patients with AML: Patients \\\u003C21 years, however, are eligible with (M2 marrow) with \\\u003C 25% blasts in marrow after having failed one or more cycles of chemotherapy.\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma: second or greater CR; CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n* High risk ALL is defined as having one of the following:\n\n  * Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n  * 30 years of age or older at diagnosis\n  * White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n  * CNS leukemia involvement during the course of disease\n  * Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n  * Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy\n* Very high risk pediatric patients with ALL: patients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieve a complete remission.\n* Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors.\n* Plasma Cell Leukemia after initial therapy, in patients who have achieved at least a partial remission\n* Myeloproliferative Neoplasms\u002FMyelofibrosis, either primary as a result of polycythemia vera or essential thrombocythemia, with disease risk of intermediate or high-risk according to DIPSS criteria. Blasts must be \\\u003C10% by bone marrow aspirate morphology.\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features. Blasts must be \\\u003C 10% by a representative bone marrow aspirate morphology.\n* Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression\u002Frelapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant.\n* Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.\n* Diffuse large Cell NHL \\> CR\u002F\\> PR: Patients in CR\u002FPR with initial short remission (\\\u003C6 months) are eligible, or those who have failed\u002For are not eligible for autologous transplant.\n* Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III\u002FIV in CR1\u002FPR1 or after progression if stage I\u002FII \\\u003C 1 year.\n* Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin \\> 3 mg\u002FL, may be considered for this protocol after initial therapy.\n* Juvenile myelomonocytic leukemia\n* Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n* MRD positive leukemia (AML, ALL or accelerated\u002Fblast phase CML). Selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status.\n* Natural Killer Cell Malignancies\n* Acquired Bone Marrow Failure Syndromes except for Fanconi Anemia or Dyskeratosis Congenita\n* Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nExclusion Criteria:\n\n* Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after \\> 2 salvage regimens)\n* CML in blast crisis\n* Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy.\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.\n* Active central nervous system malignancy\n* if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If \\>18 years old prior myeloablative allotransplant or autologous transplant\n* Active HIV infection or known HIV positive serology\n* active uncontrolled infection\n* Pregnant or breastfeeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.","60 Years",{"count":126,"type":22},300,[92],"This is a Phase II study of allogeneic hematopoietic stem cell transplant (HCT) using a myeloablative preparative regimen (of either total body irradiation (TBI); or, fludarabine\u002Fbusulfan for patients unable to receive further radiation). followed by a post-transplant graft-versus-host disease (GVHD) prophylaxis regimen of post-transplant cyclophosphamide (PTCy), tacrolimus (Tac), and mycophenolate mofetil (MMF).",[130,30,29,131,132,133,134,37,135,136,137,31,99,138,139,140,141,142,143,35,144,145,146,147,148,149,150,151],"Acute Leukemia","Lymphoma","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Myeloproliferative Neoplasms","Myelodysplasia","Refractory Anemia","High Risk Anemia","Marginal Zone B-Cell Lymphoma","Follicular Lymphoma","Lymphoplasmacytic Lymphoma","Mantle-Cell Lymphoma","Prolymphocytic Leukemia","Diffuse Large Cell Non Hodgkins Lymphoma","Burkitt Lymphoma","High Grade Non-Hodgkin's Lymphoma, Adult","Multiple Myeloma","Juvenile Myelomonocytic Leukemia","Biphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias","MRD Positive Leukemia","Natural Killer Cell Malignancies","Acquired Bone Marrow Failure Syndromes",[153,17,154,155,102,156,157],"AML","MDS","NHL","CML","SLL",{"date":159,"type":44},"2026-06-25",{"date":161,"type":44},"2018-03-30",{"date":163,"type":22},"2028-06-10",{"name":165,"class":50},"Masonic Cancer Center, University of Minnesota",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":194},"100642229","phase-1-first-in-human-study-of-a-new-treatment-4a10-for-patients-with-relapsed-or-hard-to-treat-acute-lymphoblastic-leukemia-or-lymphoblastic-lymphoma-focused-on-safety-and-how-the-drug-behaves-in-the-body-and-early-signs-of-effect-100642229","NCT07586618","First-in-human Study of a New Treatment (4A10) for Patients With Relapsed or Hard-to-treat Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma, Focused on Safety and How the Drug Behaves in the Body and Early Signs of Effect.","A First in Human, Phase 1, Open-Label Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 4A10 Monotherapy In Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma","ALT-101","Key Inclusion Criteria:\n\n1. Confirmed diagnosis of T\u002FB-ALL or T\u002FB-LL\n2. Relapsed or refractory disease without curative options\n3. Adequate organ function and performance status\n\nKey Exclusion Criteria:\n\n1. Patients with CNS3 disease\n2. Patients with DNA fragility syndromes (e.g., Fanconi, Bloom), trisomy 21 (Down Syndrome)\n3. Prior exposure to anti-CD127 therapies\n4. Uncontrolled infections",{"count":175,"type":22},24,[25],"ALT-101 is a first-in-human Phase 1 clinical trial testing a new antibody drug called 4A10 in patients with relapsed or hard-to-treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma.\n\n4A10 is a targeted therapy designed to recognize and attach to a specific protein (CD127) found on leukemia cells. Once it binds, it works in two ways: it blocks growth signals that help cancer cells survive, and it helps the immune system find and destroy those cancer cells.\n\nIn this study, patients receive 4A10 through an intravenous (IV) infusion once a week. The main goal of the trial is to find out if the drug is safe, what dose can be given, and how the body processes it. Researchers will also look for early signs that the treatment may be working.\n\nThe study starts with small groups of patients receiving increasing doses to carefully monitor safety. Each patient is closely observed during the first treatment cycle (about 4-6 weeks) to watch for side effects. If the treatment is helping and is well tolerated, patients may continue treatment for up to six cycles.\n\nOverall, this study is an early step in testing a new, targeted immune-based therapy for difficult-to-treat blood cancers.",[35,179],"Acute Lymphoblastic Leukemia ALL",[181,182,183],"Leukemia","Refractory","Relapsed","2026-06-09",{"date":186,"type":44},"2026-06-11",{"date":188,"type":44},"2026-06-01",{"date":190,"type":22},"2028-09",{"name":192,"class":193},"Allterum Therapeutics, Inc","INDUSTRY",4,{"id":196,"slug":197,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":16,"sex":17,"minAge":202,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":205,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":222,"leadSponsor":224,"locationsCount":80},"100643735","strength-training-exercise-in-pediatric-acute-lymphoblastic-leukemia-and-lymphoblastic-lymphoma-step-all-100643735","NCT07634653","Strength Training Exercise in Pediatric Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (STEP-ALL)","STEP-ALL","Inclusion Criteria for children:\n\nAll subjects must meet the following criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. OR Written assent and parental\u002Flegal guardian consent.\n* Age \\>= 6 and \\\u003C =21 years at the time of diagnosis.\n* Newly- diagnosed with one of the following diseases: B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma\n\nExclusion Criteria for children:\n\n* Subjects must not be receiving any investigational or additional anti-cancer medicines during induction.\n* Significant concurrent disease, illness, or psychiatric disorder or social issue that would compromise subject safety or adherence to the protocol treatment or procedures, interfere with consent, study participation, follow-up, or interpretation of the study results.\n\nOptional caregiver participation:\n\nInclusion Criteria :All caregivers must meet the following criteria\n\n* Written informed consent to participate in the caregiver interviews.\n* The caregiver must be a parent or legal guardian ≥ 18 years old, and their child must be \\\u003C18 years","6 Years",{"count":204,"type":22},40,[63],"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.",[181,130,208,35,29],"Acute Lymphoid Leukemia",[210,211,212,213,214,215,216],"children","pediatric","weight gain","body mass index (BMI)","physical activity","Exercise","hybrid exercise program","NOT_YET_RECRUITING","2026-06-08",{"date":220,"type":44},"2026-06-10",{"date":218,"type":22},{"date":223,"type":22},"2028-06-01",{"name":225,"class":50},"UNC Lineberger Comprehensive Cancer Center",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":16,"sex":17,"minAge":233,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":80},"100377523","phase-2-donor-stem-cell-transplant-with-treosulfan-fludarabine-and-total-body-irradiation-for-the-treatment-of-hematological-malignancies-100377523","NCT04195633","Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies","Hematopoietic Stem Cell Transplantation From Haploidentical Donors in Patients With Hematological Malignancies Using a Treosulfan-Based Preparative Regimen","Inclusion Criteria:\n\n* Acute leukemia (AL) that includes acute myeloid leukemia (AML) \u002F acute lymphoblastic leukemia (ALL) \u002F mixed phenotype leukemia (MPAL) in complete morphological remission (CR) with or without detectable minimal residual disease (MRD); complete morphological remission is defined by the presence of less than 5% of detectable blasts in bone marrow specimen, evaluated per standard of care. Patients with documented CR but without hematologic recovery since last chemotherapy are considered eligible to the study\n* Chronic myelogenous leukemia (CML), except refractory blast crisis. To be eligible in first chronic phase, patients must have failed or be intolerant to at least one tyrosine-kinase inhibitor\n* Chronic myelomonocytic leukemia (CMML)\n* Myelodysplastic syndromes (MDS)\n* Lymphoblastic, Burkitt's and other high-grade lymphoma in any complete (CR) or partial (PR) response\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Low grade lymphoma (chronic lymphocytic leukemia \\[CLL\\]\u002Fsmall lymphocytic lymphoma \\[SLL\\], marginal zone lymphoma, follicular lymphoma) progressed after two treatment regimens, in CR\u002FPR\n\n  * For CLL\u002FSLL, CR and PR are defined according to: International Workshop on CLL (iwCLL) guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Large cell lymphoma in \\> second CR (CR2)\u002F \\>= PR2\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Mantle cell lymphoma, lymphoplasmacytic lymphoma and prolymphocytic leukemia may be eligible after initial therapy if in CR\u002FPR\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n  * For prolymphocytic leukemia (PLL), CR is defined as a normalization of lymphadenopathies (long-axis diameter \\\u003C 1 cm) and splenomegaly (\\\u003C 13 cm), absence of constitutional symptoms, PLL cells \\\u003C 5% in bone marrow and circulating lymphocytes count \\\u003C 4 x 10\\^9\u002FL. Patients without hematopoietic recovery are considered eligible to the study. PR is defined as a decrease of \\>= 30% of the sum of lymphadenopathies' long-axis diameters, a decrease of \\>= 50% in spleen vertical length beyond normal from baseline, peripheral blood (PB) lymphocytes =\\\u003C 30 x 10\\^9\u002FL (and a decrease of \\>= 50% from baseline)\n* Hodgkin Lymphoma in \\> CR2\u002FPR2\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Subjects must be \\>= 6 months old\n* Karnofsky \\>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1 (for adults)\n* Lansky score \\>= 50 (for children)\n* Adequate cardiac function defined as absence of decompensated congestive heart failure or uncontrolled arrhythmia AND left ventricular ejection fraction \\>= 40% or shortening fraction \\> 22%\n* Adequate pulmonary function defined as absence of oxygen (O2) requirements and one of the following:\n\n  * Diffusion capacity of the lung for carbon monoxide (DLCO) corrected \\>= 70% mm Hg\n  * DLCO corrected between 60% - 69% mm Hg and partial pressure of oxygen (pO2) \\>= 70 mm Hg\n  * DLCO corrected between 50% - 59% mm Hg and pO2 \\>= 80 mm Hg Pediatric patients unable to perform pulmonary function tests must have O2 saturation \\>= 92% on room air. May not be on supplemental oxygen\n* Total bilirubin \\\u003C 2 x upper limit of normal (ULN) unless felt to be related to Gilbert's disease or hemolysis\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* Alkaline phosphatase =\\\u003C 5 x ULN\n* Creatinine \\\u003C 2.0 mg\u002Fdl (adults) or estimated creatinine clearance \\> 40 ml\u002Fmin (pediatrics)\n\n  * All adults with a creatinine \\> 1.2 or a history of renal dysfunction must have estimated creatinine clearance \\> 40 ml\u002Fmin\n* If recent mold infection, e.g., aspergillus, must be cleared by infectious disease to proceed\n* Patients who have undergone prior allogeneic hematopoietic cell transplant are eligible, but the prior transplant must have been performed at least 3 months prior to enrollment, unless in case of graft failure from the prior transplant\n* Written and signed informed consent\n* DONOR: Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should share at least 5\u002F10 HLA loci\n* DONOR: Age \\>= 12 years\n* DONOR: Weight \\>= 40 Kg\n* DONOR: Ability of donors younger than 18 years of age to undergo apheresis without use of a vascular access device. Vein check must be performed and verified by an apheresis nurse prior to arrival.\n* DONOR: Donor must meet selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines\n* DONOR: In case of more available haploidentical donors, selection criteria should include, in this order:\n\n  * For cytomegalovirus (CMV) seronegative recipients, a CMV seronegative donor\n  * Red blood cell compatibility\n\n    * Red blood cell (RBC) cross match compatible\n    * Minor ABO incompatibility\n    * Major ABO incompatibility\n\nExclusion Criteria:\n\n* Active, uncontrolled, life-threatening viral, bacterial or fungal infection requiring treatment at time of conditioning regiment administration and transplantation\n* Presence of a malignancy other than the one for which the transplant is being performed, with an expected survival less than 75% at 5 years\n* Pregnant or breastfeeding\n* Known hypersensitivity to treosulfan, fludarabine or cyclophosphamide\n* Dosing with another investigational agent within 30 days prior to entry in the study\n* Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy and\u002For cranial radiation prior to initiation of conditioning (day -6)\n* DONOR: Since detection of anti-donor-specific-antigen antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patients with DSA mean fluorescent intensity (MFI) \\\u003C 5000 after desensitization treatment, will be considered eligible to participate in the study. The first 10 subjects enrolled in the trial will be DSA-negative.","6 Months",{"count":61,"type":22},[92],"This phase II trial studies how well a donor stem cell transplant, treosulfan, fludarabine, and total-body irradiation work in treating patients with blood cancers (hematological malignancies). Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.",[130,29,30,238,239,144,240,241,34,35,140,242,243,36,142,244,245,246,247],"Adult Diffuse Large Cell Lymphoma","Anaplastic Large Cell Lymphoma","Chronic Myeloid Leukemia, BCR-ABL1 Positive","Chronic Myelomonocytic Leukemia","Mantle Cell Lymphoma","Mixed Phenotype Acute Leukemia","Refractory Chronic Lymphocytic Leukemia","Refractory Follicular Lymphoma","Refractory Marginal Zone Lymphoma","Refractory Small Lymphocytic Lymphoma","2026-05-27",{"date":250,"type":44},"2026-05-29",{"date":252,"type":44},"2021-01-25",{"date":254,"type":22},"2029-03-12",{"name":256,"class":50},"Fred Hutchinson Cancer Center",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":266,"phases":4,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":285},"100193148","effects-of-dexrazoxane-hydrochloride-on-biomarkers-associated-with-cardiomyopathy-and-heart-failure-after-cancer-treatment-100193148","NCT01790152","Effects of Dexrazoxane Hydrochloride on Biomarkers Associated With Cardiomyopathy and Heart Failure After Cancer Treatment","Health Effects After Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-Related Cardiomyopathy","Inclusion Criteria:\n\nStudy Strata I, II, and III are closed for further patient entry as of March 31, 2021. The study remains open for existing medical record submission of Stratum IV\n\n* STRATUM I AND STRATUM II: LEUKEMIA AND LYMPHOMA SURVIVORS\n* Previously enrolled leukemia and lymphoma survivors, randomized to + or - DRZ on P9404, P9425, P9426, or DFCI 95-01 (high-risk patients only)\n* STRATUM I: Alive and in continuous first complete remission from their original cancer (leukemia\u002Flymphoblastic lymphoma \\[P9404, high-risk DFCI 95-01\\] or Hodgkin lymphoma \\[P9425\u002FP9426\\])\n* STRATUM I: Did not have progressive disease or induction failure requiring off-protocol therapy including hematopoietic cell transplantation\n* STRATUM I: Must not have been diagnosed with any subsequent malignancy that required additional cardiotoxic therapies (i.e., radiotherapy to the chest \\[also includes fields directed towards the neck, upper abdomen, or spine\\], or additional anthracyclines or anthraquinones); patients with history of subsequent malignancy that did not require such therapies remain eligible\n* STRATUM I: All patients and\u002For their parents or legal guardians must sign a written informed consent\n* STRATUM II: Among leukemia and lymphoma patients randomized to + or - DRZ on P9404, P9425, P9426, and DFCI 95-01 (high risk patients only) who have relapsed or have experienced a subsequent malignancy that precludes eligibility since their original diagnosis, the study committee will review the available data (both from Children's Oncology Group's \\[COG?s\\] Statistics and Data Center \\[SDC\\] and the participating institution) to determine if individual patients are to be selected for Stratum 2; in recognition that local institutions sometimes have more updated relapse\u002Fsubsequent cancer data than SDC, in cases where local data is more updated, local data will be used preferentially; the study will petition the Institutional Review Board (IRB) specifically for a waiver of consent to include any relapse and subsequent cancer data obtained from existing records for analysis of the secondary aims; patients selected for Stratum 2 will be those for whom late relapse or subsequent cancer is reported but who lack clear confirmation in existing records (either at SDC or at the local institution)\n* STRATUM II: Alive, but have experienced relapse of their original cancer and\u002For have developed a subsequent cancer (other than non-melanomatous skin cancer) since their original diagnosis\n* STRATUM II: All patients and\u002For their parents or legal guardians must sign a written informed consent\n* STRATUM III: OSTEOSARCOMA SURVIVORS\n* Previously enrolled osteosarcoma survivors treated on P9754 who are alive and able (themselves and\u002For parents\u002Flegal guardian) to provide written informed consent; note that relapse and subsequent malignancy are not exclusion criteria for P9754 survivors\n* Comparison subjects for P9754 survivors will be eligible to be enrolled from any ALTE11C2 participating COG site (even if that institution did not participate on P9754), according to the following criteria:\n\n  * Newly diagnosed, previously untreated biopsy-proven moderate or high grade osteosarcoma without metastasis; patients with low grade osteosarcoma, parosteal or periosteal sarcoma are ineligible\n  * \\\u003C 31 years of age at time of initial osteosarcoma diagnosis\n  * Diagnosis occurred between January 1, 1999 through December 31, 2002; duration of therapy can extend beyond 2002\n  * No evidence of poor or low cardiac function at time of initial osteosarcoma diagnosis; if reports from the time are available: shortening fraction \\>= 28% by echocardiogram and within the institutional normative range for age, or radionuclide angiogram ejection fraction \\>= 50%; if imaging reports from the time are no longer available, there must be no documentation within available medical records that suggest poor or low cardiac function at time of diagnosis\n  * Comparison subject must have institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) documenting lifetime receipt of 450 to 600 mg\u002Fm\\^2 of doxorubicin (doses within 10% are acceptable); this includes initial therapy as well as any subsequent therapy for relapse or second cancer, if relevant; as such, comparison subjects who have had osteosarcoma relapse or subsequent malignancies remain eligible so long as they meet all other eligibility criteria\n  * No anthracycline or anthraquinone aside from doxorubicin was ever given as part of initial or subsequent therapies\n  * No exposure to DRZ at any point in time\n  * All patients and\u002For their parents or legal guardians must sign a written informed consent\n* STRATUM IV: CARDIOMYOPATHY CASES, NOT OTHERWISE ELIGIBLE FOR STRATUMS 1, 2, AND 3\n* Individuals diagnosed with cancer prior to age 21 years, who required treatment with chemotherapy and\u002For radiotherapy, achieved initial remission, and remained alive after completing anti-cancer-therapy for at least 1 year\n* Must have screening echocardiograms for heart function as part of cancer therapy and off-therapy evaluations available (Digital Imaging and Communications in Medicine \\[DICOM\\] format). Images from Video Home System (VHS) tapes and reports only (without images) are not suitable\n* Cannot have a known history of congenital heart disease (patent foramen ovale remain eligible) or underlying genetic syndrome associated with abnormal cardiovascular development or health (e.g., down syndrome)\n* Based on echocardiography, must have either left ventricular fractional shortening =\\\u003C 28.0% or ejection fraction =\\\u003C 50.0% on at least two occasions, with at least one of these measurements occurring after cancer therapy completion and be in the absence of sepsis or any uncontrolled infection\n* If the fractional shortening or ejection fraction criteria is only met on one occasion, this must be after cancer therapy completion, be in the absence of sepsis or any uncontrolled infection, and the patient must have subsequently started on chronic medical therapy for cardiomyopathy (e.g., beta-blocker, angiotensin-converting enzyme \\[ACE\\]-inhibitor, angiotensin receptor blocker) lasting at least 6 months\n* For all participants (stratums 1, 2, 3, and 4), all institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met",{"count":265,"type":22},420,"OBSERVATIONAL","This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.",[269,270,35,271,272,273,274],"Hodgkin Lymphoma in Remission","Leukemia in Remission","Osteosarcoma","Recurrent Leukemia","Recurrent Lymphoma","Recurrent Malignant Neoplasm","2026-05-14",{"date":277,"type":44},"2026-05-18",{"date":279,"type":44},"2014-03-05",{"date":281,"type":22},"2026-12-31",{"name":283,"class":284},"Children's Oncology Group","NETWORK",79,{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":16,"sex":17,"minAge":233,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":23,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},"100345603","phase-2-naive-t-cell-depletion-for-preventing-chronic-graft-versus-host-disease-in-children-and-young-adults-with-blood-cancers-undergoing-donor-stem-cell-transplant-100345603","NCT03779854","Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant","Multi-Center Phase II Randomized Controlled Trial of Naïve T Cell Depletion for Prevention of Chronic Graft-Versus-Host Disease in Children and Young Adults","Inclusion Criteria:\n\n* The patient must have one of the following diagnoses and be considered to be an appropriate candidate for allogeneic HCT by the study site principal investigator (PI):\n\n  * Acute lymphoblastic leukemia (ALL) with \\\u003C 5% marrow blasts.\n  * Acute myeloid leukemia (AML) with \\\u003C 25% marrow blasts.\n  * Other acute leukemia (OAL) or related neoplasm (including but not limited to acute biphenotypic leukemia \\[ABL\\], ambiguous lineage \\[ALAL\\], mixed phenotype acute leukemia \\[MPAL\\], blastic plasmacytoid dendritic cell neoplasm \\[BPDCN\\], acute undifferentiated leukemia \\[AUL\\], lymphoblastic lymphoma, Burkitt leukemia\u002Flymphoma, mast cell leukemia, chronic monocytic leukemia \\[CML\\] with blast crisis or other chronic myeloproliferative neoplasm) with \\\u003C 5% marrow blasts.\n  * Myelodysplastic syndrome (MDS) with excess blasts (EB-1 and EB-2) and has received cytotoxic induction chemotherapy (excluding small molecule inhibitors and de-methylating agents)\n* Age 6 months to 26 years at the time informed consent is obtained using the Informed Consent to Participate in a Research Study form\n* Matched related donor (MRD) or matched unrelated donor (MUD) (defined as 8\u002F8 match for human leukocyte antigen \\[HLA\\]-A, -B, -C, -DRB1).\n* Planned product type for infusion is PBSC or BM (i.e. not cord blood):\n\n  * For feasibility phase, planned product type for infusion must be PBSC.\n  * For RCT, planned product type must be PBSC or BM.\n* Karnofsky or Lansky score \\>= 60%.\n* Left ventricular ejection fraction (LVEF) at rest \\>= 40%.\n* Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for hemoglobin) \\>= 60% predicted by pulmonary function tests (PFTs)\n\n  \\* Patients who are unable to perform PFTs (age \\\u003C 6 years or considered developmentally incapable of PFTs): oxygen saturation (by oximetry) must be \\>= 92% on room air.\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) (unless value\\[s\\] \\> 2 x ULN are disease- or medication-related).\n\n  \\* If value(s) are \\> 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal (GI) physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\\\u003C 2 x ULN (unless value\\[s\\] \\> 2 x ULN are disease- or medication-related).\n\n  \\* If value(s) are \\> 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal GI physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.\n* Serum creatinine (SCr) within normal range for age. If SCr is outside normal range for age, creatinine clearance (CrCl) \\> 40 mL\u002Fmin\u002F1.73m\\^2 must be obtained (measured by 24-hour \\[hr\\] urine specimen or nuclear glomerular filtration rate \\[GFR\\]).\n\n  * Age (Years): Maximum SCr (mg\u002FdL)\n  * =\\\u003C 5: 0.8\n  * 6-10: 1\n  * 11-15: 1.2\n  * \\> 15: 1.5\n* Recipient informed consent\u002Fassent\u002Flegal guardian permission documentation must be obtained.\n* DONOR: May be related (MRD) or unrelated (MUD) to the subject.\n* DONOR: Must be matched to the subject at 8\u002F8 HLA alleles (HLA-A, -B, -C, and -DRB1)\n* DONOR: Be \\>=14 years of age.\n* DONOR: Must be available to donate in the United States of America (USA) (i.e. excludes international donors).\n* DONOR: Must agree to donate BM or PBSC (i.e. agree to donate whichever product type is requested) (applicable only to the RCT phase of this study).\n* DONOR: MUDs:\n\n  * Must give informed consent according to applicable National Marrow Donor Program (NMDP) donor regulatory requirements\n  * Must meet eligibility criteria as defined by the NMDP or be ineligible with statement of urgent medical need (exception 21 CFR 1271.65(b)(iii))\n\n    * Tests must be performed using Food and Drug Administration (FDA) licensed, cleared, and approved test kits in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory\n* DONOR: MRDs:\n\n  * Must be negative for human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2, hepatitis B, hepatitis C (serological and\u002For nucleic acid testing \\[NAT\\] and\u002For other approved testing)\n  * Must meet institutional donor eligibility criteria, or be ineligible with statement that the donor is a first or second degree relative (exception 21 CRF 1271.65(b)(i)).\n\n    * Tests must be performed using FDA licensed, cleared, and approved test kits in a CLIA-certified laboratory.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease. A patient may have a history of CNS disease; however, any CNS disease must be cleared by the end of the pre-conditioning evaluation. If CNS disease is identified on the first cerebrospinal fluid (CSF) evaluation within 30 days of the start of the preparative regimen, a repeat CSF evaluation must be performed and show no evidence of disease in order for the patient to be eligible for the protocol.\n* Patients on other experimental protocols for the prevention of GVHD.\n* Patient body weight:\n\n  * Matched related donor (MRD): \\> 100 kg are ineligible\n  * Matched unrelated donor (MUD): \\> 75 kg must be discussed with the protocol principal investigator (PI) prior to enrollment.\n* HIV-positive.\n* Uncontrolled infections must be evaluated by an infectious disease physician and considered suitable to undergo HCT by the study site PI, infectious disease physician and protocol PI. Upper respiratory tract infection (URI) does not constitute an uncontrolled infection in this context.\n* Life expectancy \\\u003C 3 months from disease other than acute leukemia or myelodysplastic syndrome (MDS).\n* Significant medical condition that would make recipient unsuitable for HCT.\n* Prior allogeneic or autologous HCT.\n* Females who are pregnant or breastfeeding.\n* Patients of child bearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during study treatment and for 12 months following HCT.\n* Known hypersensitivity to tacrolimus, fludarabine, or methotrexate (MTX).","26 Years",{"count":295,"type":22},68,[92],"This phase II trial studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body's normal tissues (called graft versus host disease). Removing a particular type of T cell (naive T cells) from the donor cells before the transplant may stop this from happening.",[299,130,300,29,301,302,303,304,305,243,306,307,308,309,35,310,38],"Acute Biphenotypic Leukemia","Acute Leukemia of Ambiguous Lineage","Acute Undifferentiated Leukemia","Allogeneic Hematopoietic Stem Cell Transplantation Recipient","Blastic Plasmacytoid Dendritic Cell Neoplasm","Blasts Under 25 Percent of Bone Marrow Nucleated Cells","Blasts Under 5 Percent of Bone Marrow Nucleated Cells","Myelodysplastic Syndrome With Excess Blasts-1","Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Burkitt Leukemia","Chronic Monocytic Leukemia","Mast Cell Leukemia","2026-05-11",{"date":275,"type":44},{"date":314,"type":44},"2019-08-29",{"date":316,"type":22},"2028-12-31",{"name":256,"class":50},10,{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":17,"minAge":326,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":23,"phases":329,"briefSummary":330,"conditions":331,"keywords":333,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":344},"100555646","phase-2-a-phase-2-study-of-wu-cart-007-an-anti-cd7-allogeneic-car-t-cell-therapy-in-t-cell-acute-lymphoblastic-leukemia-and-lymphoblastic-lymphoma-t-rrex-100555646","NCT06514794","A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)","A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With Relapsed\u002FRefractory Cell Acute Lymphoblastic Leukemia\u002FLymphoblastic Lymphoma (T-RRex)","Key Inclusion Criteria:\n\n* Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse\u002Frefractory or MRD positive\n* Age: Lower age limit of ≥ 6 months; adequate organ function\n* Eastern Cooperative Oncology Group (ECOG)\u002FKarnofsky Performance Status 0 or 1\u002F70 and above at Screening.\n\nKey Exclusion Criteria:\n\n* Prior treatment with any anti-CD7 therapy.\n* Patients with decompensated hemolytic anemia.\n* Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression. Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.","1 Year",{"count":328,"type":22},125,[92],"The T-RRex study evaluates the efficacy of WU-CART-007 for patients with Relapsed\u002FRefractory (R\u002FR) T-Cell Acute Lymphoblastic Leukemia (T-ALL)\u002FLymphoblastic Lymphoma (LBL) and to WU-CART-007 as a therapy to induce complete Minimum Residual Disease (MRD) negative response",[332,35],"T-cell Acute Lymphoblastic Leukemia",[334],"CAR-T Therapy","2026-05-09",{"date":337,"type":44},"2026-05-12",{"date":339,"type":44},"2025-01-31",{"date":341,"type":22},"2028-12-30",{"name":343,"class":193},"Wugen, Inc.",15,{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":17,"minAge":352,"maxAge":353,"enrollmentInfo":354,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":80},"100500332","mcw-alphabeta-t-cell-and-b-cell-depletion-with-targeted-atg-dosing-100500332","NCT05794880","MCW Alpha\u002FBeta T-Cell and B-Cell Depletion With Targeted ATG Dosing","Matched Unrelated Donor and Partially Matched Related Donor Peripheral Stem Cell Transplantation With Alpha\u002FBeta T-Cell and B-Cell Depletion for Patients With Hematologic Malignancies With Targeted ATG Dosing Pilot Study, IDE 13641","Inclusion Criteria:\n\n1. Patient age \\\u003C 25 years. Both genders and all races eligible.\n2. Disease eligibility\n\n   * Acute myeloid leukemia, primary or secondary - Disease status: MRD negative (flow MRD ≤ 0.1%)\n   * Myelodysplasia\n   * Acute lymphoblastic leukemia - Disease status: MRD negative\n   * Chronic myelogenous leukemia - Disease status: chronic phase, accelerated phase or blast crisis now in second chronic phase\n   * Mixed lineage or biphenotypic acute leukemia- Disease status: MRD negative\n   * Lymphoblastic lymphoma - Disease status: in remission\n   * Burkitt's lymphoma\u002Fleukemia - Disease status: in remission\n   * Lymphoma after relapse - Disease status: in remission\n   * Other malignant hematologic diseases in remission (to be approved by PI)\n3. Karnofsky Performance Status ≥ 60% for patients 16 years and older and Lansky Play Score ≥ 60 for patients under 16 years of age (Appendix 1)\n4. Evaluation of organ status as per MCW BMT SOP\n5. Infectious disease criteria: No active untreated infection. Patients with possible fungal infections must have had at least 2 weeks of appropriate anti-fungal antibiotics and be asymptomatic.\n6. Signed consent by parent\u002Fguardian or able to give consent if ≥18 years.\n7. Negative pregnancy test for patients capable of childbearing potential\n8. Sexually active patients capable of child-bearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device \\[IUD\\], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment. Sexually active men must agree to use barrier contraceptive for the duration of treatment.\n\nDonor Eligibility:\n\n1. Unrelated donor meets National Marrow Donor Program criteria for donation\n2. Infectious disease testing\n3. MCW BMT procedures apply for determining donor eligibility, including donor screening and testing for relevant communicable disease agents and diseases.\n4. Only Peripheral blood stem cells will be used for stem cell source on this study therefore donor must be willing to undergo G-CSF mobilization and stem cell apheresis. Donor matching. High resolution typing at all loci to be performed.\n5. Unrelated Donor:\n\n   a. HLA typing of at least 10 alleles is required. Donor must be matched at 9\u002F10 or 10\u002F10 alleles (HLA A, B, C, DRB1, DQB1).Donor and collection center willing to undergo mobilization and apheresis\n6. Haploidentical Related Donor:\n\n   1. Haploidentical parent or other related donor: Minimum match level full haploidentical (at least 5\u002F10; HLA A, B, C, DRB1, DQB1 alleles), but use of haploidentical donors with extra matches (e.g. 6, 7, or 8\u002F10) encouraged.\n\nExclusion Criteria:\n\n1. Patients who do not meet disease, organ, or infectious criteria.\n2. No suitable donor\n3. Pregnant or lactating patients are ineligible as many of the medications used in this protocol could be harmful to unborn children and infants\n4. Receiving concomitant chemotherapy, radiation therapy; immunotherapy or other anti-cancer therapy for treatment of disease other than is specified in the protocol. Maintenance or other post-HCT therapy can be considered after discussion with the study PI.\n5. Participating in a concomitant Phase 1 or 2 study involving treatment of disease\n6. Active malignancy other than eligible disease specified in the protocol. Patients with prior malignancy can be eligible as long as at least 1 year post treatment for that malignancy.","0 Years","25 Years",{"count":204,"type":22},[63],"This is a single arm pilot study for patients with hematologic malignancies receiving unrelated or haploidentical related mobilized peripheral stem cells (PSCs) using the CliniMACS system for alpha\u002Fbeta T cell depletion plus CD19+ B cell depletion with individualized ALC-based dosing of ATG to study impact on engraftment, GVHD, and disease free survival",[181,358,135,359,360,361,362,363,35,144,308,364,365],"Acute Myeloid Leukemia in Remission","Acute Lymphoblastic Leukemia in Remission","Chronic Myelogenous Leukemia - Chronic Phase","Chronic Myelogenous Leukemia, Accelerated Phase","Chronic Myelogenous Leukemia With Crisis of Blast Cells","Biphenotypic Acute Leukemia","Lymphoma After Relapse","Other Malignant Hematologic Diseases in Remission","2026-05-08",{"date":368,"type":44},"2026-05-13",{"date":370,"type":44},"2023-05-01",{"date":372,"type":22},"2032-05",{"name":374,"class":50},"Medical College of Wisconsin",{"id":376,"slug":377,"hasResults":11,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":17,"minAge":326,"maxAge":18,"enrollmentInfo":382,"targetDuration":4,"studyType":23,"phases":384,"briefSummary":385,"conditions":386,"keywords":387,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":402},"100557102","phase-2-therapy-for-newly-diagnosed-patients-with-b-cell-precursor-acute-lymphoblastic-leukemia-and-lymphoma-100557102","NCT06533748","Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma","SJALL23H: Combination Antigen-Directed Induction Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma","Inclusion Criteria:\n\n* Enrollment on INITIALL.\n* Age 1-18.99 years at the time of enrollment on INITIALL.\n* B-Acute lymphoblastic leukemia or lymphoblastic lymphoma.\n* No prior chemotherapy excluding therapy given on or allowed by INITIALL.\n* NCI high-risk (age 10 years or greater or presenting WBC count ≥50,000 cells\u002FmicroL) or NCI standard-risk and a HR clinical feature as listed below:\n\n  * CNS3 disease (≥5 WBC\u002FmicroL CSF with blasts present)\n  * Testicular involvement of leukemia\n  * Steroid pretreatment defined as \\>24 hours of therapy in the 14 days prior to enrollment on INITIALL if a preceding WBC to define NCI risk is unavailable\n* For lymphoblastic lymphoma, Stage 3-4 disease OR Stage 1-2 disease in patient ages ≥10 years OR HR clinical feature as defined above.\n* Adequate liver function defined as:\n\n  * Total bilirubin ≤ 1.5x the upper limit of normal for age and alanine transaminase (ALT) ≤ 5x the upper limit of normal for age. Patients with an elevated total bilirubin due to hemolysis are eligible if they have a direct bilirubin \\\u003C1.5x the upper limit of normal.\n* Adequate renal function defined as:\n\n  * Calculated glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73m\\^2 using the Bedside Schwartz equation OR creatinine below or equal to the maximum defined below:\n\n    * Age: 1 to \\\u003C2 years; maximum serum creatinine (mg\u002FdL): 0.6 (male and female)\n    * Age: 2 to \\\u003C6 years; maximum serum creatinine (mg\u002FdL): 0.8 (male and female)\n    * Age: 6 to \\\u003C10 years; maximum serum creatinine (mg\u002FdL): 1.0 (male and female)\n    * Age: 10 to \\\u003C13 years; maximum serum creatinine (mg\u002FdL): 1.2 (male and female)\n    * Age: 13 to \\\u003C16 years; maximum serum creatinine (mg\u002FdL): 1.5 (male); 1.4 (female)\n    * Age: ≥16 years; maximum serum creatinine (mg\u002FdL): 1.7 (male); 1.4 (female)\n* Eligibility for inclusion post-induction requires meeting the first 4 Inclusion criteria above AND:\n\n  * Treatment on SJALL23H for Induction OR\n  * Lymphoblastic lymphoma, initially treated on an SJALL protocol OR standard (non-protocol) therapy, without a complete response at the end of induction OR\n  * NCI-SR ALL at diagnosis and treated with an SJALL protocol OR standard (non-protocol) therapy who have\n\n    * Slow response to therapy (≥0.1% MRD at end of induction for patients with hyperdiploid ALL or ≥0.01% MRD at end of induction for others with ALL) OR\n    * HR genetics as defined in the protocol.\n    * These patients may receive no more than 2 weeks of post-induction therapy and should be transitioned to SJALL23H post-induction as soon as the qualifying genetic or MRD result is available.\n\nExclusion Criteria:\n\n* Presence of ETV6::RUNX1 fusion unless also having a HR clinical feature OR slow response to induction therapy.\n* History or presence of clinically relevant central nervous system (CNS) pathology or event such as epilepsy, childhood or adult non-febrile seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. History of simple febrile seizure during childhood and presence of CNS leukemia at diagnosis are not exclusions to participation.\n* Active uncontrolled infection.\n* Current active autoimmune disease or history of autoimmune disease with the potential for CNS involvement.\n* History of venoocclusive disease\u002F sinusoidal obstructive syndrome.\n* Unstable cardiac disease including QTc \\>500msec.\n* Inability or unwillingness to give informed consent\u002F assent as applicable.\n* Pregnant or lactating.\n* For patients of reproductive potential, unwillingness to use effective contraception for the duration of protocol therapy.",{"count":383,"type":22},128,[92],"This is a Phase II clinical trial testing the use of two antigen-directed therapies, inotuzumab and blinatumomab, as part of induction therapy for children and young adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia and lymphoma.\n\nPrimary Objective\n\n* To assess if the flow-cytometry assessed MRD-negative remission rate following an immunotherapy-based Induction in NCI-high risk patients without favorable genetic features is higher than the results of similar patients treated on AALL1131.\n\nSecondary Objectives\n\n* To compare flow-cytometry assessed MRD-negative rates at the end of Induction for patients treated with this therapy compared to similar patients treated on TOT17.\n* To compare the rate of significant toxicities in patients treated with this therapy to those treated with standard-risk therapy on TOT17.\n* To assess the event free and overall survival of patients treated with this therapy.",[29,35],[29,35,388,389,390,391,392],"Newly Diagnosed","Antigen-directed therapies","Induction therapy","Children","Young Adults","2026-04-29",{"date":395,"type":44},"2026-05-01",{"date":397,"type":44},"2025-01-23",{"date":399,"type":22},"2034-05",{"name":401,"class":50},"St. Jude Children's Research Hospital",2,{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":11,"sex":17,"minAge":326,"maxAge":18,"enrollmentInfo":410,"targetDuration":4,"studyType":23,"phases":412,"briefSummary":414,"conditions":415,"keywords":416,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":51},"100538349","phase-4-identification-of-necessary-information-for-treatment-induction-in-newly-diagnosed-acute-lymphoblastic-leukemialymphoma-100538349","NCT06289673","Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia\u002FLymphoma","INITIALL: Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia\u002FLymphoma","Inclusion Criteria:\n\n* Age 1-18.99 years\n* Diagnosis of acute leukemia \u002F lymphoma as below:\n\n  * Acute lymphoblastic leukemia (ALL) with at least 25% bone marrow blasts or definitive evidence of ALL in peripheral blood (in those without an available bone marrow sample).\n  * Lymphoblastic lymphoma (LLy) with immunophenotypic evidence of a lymphoblastic population and \\\u003C25% bone marrow blasts and less than 1,000 circulating blasts\u002F microL.\n  * Mixed phenotype acute leukemia (MPAL) with or without 25% bone marrow involvement (i.e. patients with either leukemia or lymphoma are eligible).\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Receipt of prior cancer directed therapy with the exclusion of up to 1 dose of intrathecal chemotherapy, 1 dose of vincristine, or emergency radiotherapy due to organ compromising malignant mass. There is no exclusion for prior steroid therapy.\n* Known to be currently ineligible for available SJALL therapeutic studies (e.g. receipt of prohibited therapy, no appropriate SJALL therapeutic study available, enrolled on competing trial, etc.).\n\nNote: The intention of this exclusion criterion is to enroll all newly diagnosed ALL\u002F LLy\u002F MPAL patients. If participant is screened as a potential participant for subsequent SJALL and later found to be ineligible due to information obtained during INITIALL, this will not make the participant ineligible for INITIALL.\n\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.\n* Major pre-existing abnormalities such as ataxia telangiectasia, Fanconi anemia, Charcot Marie Tooth, etc.",{"count":411,"type":22},850,[413],"PHASE4","The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy) risk category is being determined. The term \"risk\" refers to the chance of the ALL or LLy coming back after treatment.\n\nPrimary Objectives\n\n* To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia\u002Flymphoma and mixed phenotype acute leukemia\u002Flymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies.\n* To develop a central database of genomic and clinical findings.\n\nSecondary Objectives\n\n* To assess event free and overall survival data of patients enrolled on this study.",[29,35,243],[388,417,29,35,418,391,392],"Risk Category","Mixed Phenotype Acute Leukemia (MPAL)",{"date":395,"type":44},{"date":421,"type":44},"2024-12-26",{"date":423,"type":22},"2039-05",{"name":401,"class":50},{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":80},"100610170","phase-2-dose-adjusted-epoch-with-or-without-rituximab-plus-ponatinib-for-the-treatment-of-newly-diagnosed-philadelphia-chromosome-positive-acute-lymphoblastic-leukemialymphoma-100610170","NCT07224100","Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia\u002FLymphoma","Phase II Study of Dose-Adjusted EPOCH ± Rituximab + Ponatinib for Adults With Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia\u002FLymphoma","Inclusion Criteria:\n\n* Adults (age 18 years and older) with newly-diagnosed Ph+ B-ALL. Ph status will be determined by routine cytogenetics, fluorescence in situ hybridization (FISH), and\u002For reverse transcriptase-polymerase chain reaction (RT-PCR) for the BCR::ABL1 translocation\n* Marrow or blood involvement by abnormal lymphoblasts detectable by multiparameter flow cytometry (MFC)\n* Total bilirubin (TBili) ≤ 1.5 x upper limit of normal (ULN) (unless attributed to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point TBili must be ≤ 4 x ULN)\n\n  * (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the TBili is ≤ 5 x ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2.5 x institutional ULN\n\n  * (Note: Patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the ALT\u002FAST are ≤ 8 x ULN)\n* Calculated creatinine clearance of \\> 30 ml\u002Fmin\u002F1.73m\\^2, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible\n* As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment. However, adequate recovery of blood counts will be required to receive subsequent cycles\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. (Performance status of 3 will be allowed if poor performance status is thought to be directly secondary to ALL)\n* Ability to give informed consent and comply with the protocol\n* Anticipated survival of at least 3 months, independent of ALL\n* Female subjects of reproductive potential must agree to use an effective method of birth control from the time of signing the consent form until one of the following:\n\n  * For subjects not expected to receive rituximab (i.e., CD20-negative): at least 3 weeks after the last dose of ponatinib, or\n  * For subjects expected to receive rituximab (i.e., CD20-positive): at least 12 months after the last dose of rituximab\n  * A subject does not have reproductive potential if they are (1) surgically sterilized, or (2) postmenopausal (i.e., a female who is \\> 50 years old or who has not had menses for ≥ 1 year), or (3) not heterosexually active\n* Male subjects must agree to use an effective method of birth control and to not donate sperm from the time of signing the consent form until at least 3 weeks after the last dose of ponatinib\n\nExclusion Criteria:\n\n* Burkitt lymphoma\u002Fleukemia\n* No prior systemic therapy for ALL except to control acute symptoms and\u002For hyperleukocytosis (e.g., corticosteroids, cytarabine, etc.)\n* No isolated extramedullary or known parenchymal central nervous system (CNS) disease\n* History of acute pancreatitis within 1 year of enrollment or known chronic pancreatitis\n* Symptomatic atherosclerotic cardiovascular disease (e.g., myocardial infarction, cerebrovascular accident, peripheral arterial disease, etc.) within 1 year of enrollment\n* Active resistant hypertension, defined as having an ambulatory blood pressure above goal despite use of 3 antihypertensive medications from different classes\n* Venous thromboembolic event (e.g., deep venous thrombosis, pulmonary embolism) within 6 months of enrollment\n* Known hypersensitivity or intolerance to any of the agents under investigation\n* Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol\n* May not be pregnant or nursing. Pregnancy test is only required in females, unless they do not have reproductive potential. For subjects not expected to receive rituximab (i.e., CD20-negative), nursing can occur 1 week after the last dose of ponatinib. For subjects expected to receive rituximab (i.e., CD20-positive), nursing can occur 6 months after the last dose of rituximab",{"count":433,"type":22},33,[92],"This phase II trial tests the effect of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH) with or without rituximab plus ponatinib in treating patients newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia or lymphoma (ALL). Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill cancer cells. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is a drug that is used to treat many types of cancer and is being studied in the treatment of other types of cancer. Doxorubicin comes from the bacterium Streptomyces peucetius. It damages DNA and may kill cancer cells. It is a type of anthracycline antitumor antibiotic. DA-EPOCH involves a longer exposure time to doxorubicin, vincristine and etoposide compared to a higher concentration over a shorter time which may provide better tumor response. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Ponatinib blocks BCR::ABL1 and other proteins, which may help keep cancer cells from growing and may kill them. It may also prevent the growth of new blood vessels that tumors need to grow. Ponatinib is a type of tyrosine kinase inhibitor and a type of antiangiogenesis agent. Giving DA-EPOCH with or without rituximab plus ponatinib may be safe, tolerable, and\u002For effective in treating patients with newly diagnosed Ph+ ALL.",[437,438,35],"B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","B Lymphoblastic Leukemia\u002FLymphoma With t(9;22)(q34.1;q11.2); BCR-ABL1","2026-04-14",{"date":441,"type":44},"2026-04-16",{"date":443,"type":44},"2026-03-30",{"date":445,"type":22},"2028-07-31",{"name":447,"class":50},"University of Washington",{"id":449,"slug":450,"hasResults":11,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":124,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":458,"conditions":459,"keywords":476,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":80},"100495785","phase-2-mt2021-08t-cell-receptor-alphabeta-depletion-pbsc-transplantation-for-heme-malignancies-100495785","NCT05735717","MT2021-08T Cell Receptor Alpha\u002FBeta Depletion PBSC Transplantation for Heme Malignancies","Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha\u002FBeta Depletion (A\u002FB TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies","Inclusion Criteria:\n\n* Histological confirmation of hematological malignancies\n* Acute leukemias\n* Acute Myeloid Leukemia (AML) and related precursor neoplasms\n* Favorable risk AML is defined as having one of the following:\n* Acute lymphoblastic leukemia (ALL)\u002Flymphoma\n* Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia, transfusion dependence, or high risk cytogenetics or molecular features.\n* Age 60 years of age or younger at the time of consent\n* Karnofsky performance status ≥ 70% or Lansky play score 50% for ≤16 years of age.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Active uncontrolled infection within 1 week of starting preparative therapy\n* Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR.\n* Any prior autologous or allogeneic transplant\n* CML blast crisis\n* Active central nervous system malignancy",{"count":456,"type":22},70,[92],"This is a phase II, open-label, prospective study of T cell receptor alpha\u002Fbeta depletion (TCR α\u002Fβ TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies. This is a safety\u002Ffeasibility study of the investigational procedure\u002Fproduct.",[460,130,461,30,29,153,462,463,464,465,466,135,147,467,468,469,470,471,472,473,474,475,35,145],"Hematologic Malignancy","Remission","TP53","Intrachromosomal Amplification of Chromosome 21","Cytogenetic Abnormality","CNS Leukemia","Minimal Residual Disease","Somatic Mutation","PTPN11 Gene Mutation","N-RAS Gene Amplification","Neurofibromatosis 1","NF1 Mutation","CBL Gene Mutation","Monosomy 7","Chromosome Abnormality","Fetal Hemoglobin",[477,478,479,480,481,482,483,484,485,486,487,488],"Bu","Flu","G-CSF","GFSR","aGVHD","HCT","MAC","Mel","PBSCT","PTLD","RECIST","TCR","2026-03-31",{"date":491,"type":44},"2026-04-06",{"date":493,"type":44},"2023-05-11",{"date":495,"type":22},"2030-11-30",{"name":165,"class":50},{"id":498,"slug":499,"hasResults":11,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":504,"enrollmentInfo":505,"targetDuration":4,"studyType":23,"phases":507,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":519},"100586673","phase-2-asparaginase-erwinia-chrysanthemi-with-chemotherapy-for-the-treatment-of-high-risk-adults-with-newly-diagnosed-acute-lymphoblastic-leukemia-or-lymphoblastic-lymphoma-100586673","NCT06918431","Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma","A Phase 2 Study Evaluating the Safety and Efficacy of Asparaginase Erwinia Chrysanthemi- Recombinant-Rywn (Recombinant Erwinia Asparaginase) During Pediatric-Inspired Regimen in High-Risk Adults With Newly Diagnosed ALL or LBL","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Age between 18 and 39 with body mass index (BMI) ≥ 30 or age 40-54 years, regardless of BMI\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Patients with newly diagnosed Philadelphia (Ph)-negative (-) acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) according to World Health Organization (WHO) criteria\n\n  * Both B- and T-cell phenotypes are allowed.\n* CD20+ patients only: White blood cell count less than 25 x 10\\^9\u002FL prior to initiation of rituximab (within 14 days prior to day 1 of protocol therapy)\n\n  * Cytoreduction with hydroxyurea or steroid or a single dose of intrathecal chemotherapy prior to treatment may be required\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 14 days prior to day 1 of protocol therapy) (unless has Gilbert's disease or related to underlying leukemia, ≤ 3 x ULN)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN (AST ≤ 5.0 x ULN if related to underlying leukemia) (within 14 days prior to day 1 of protocol therapy)\n\n  * Note: AST ≤ 3.0 x ULN at the time of first dose of recombinant Erwinia asparaginase administration\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN (ALT ≤ 5.0 x ULN if related to underlying leukemia) (within 14 days prior to day 1 of protocol therapy)\n\n  * Note: ALT ≤ 3.0 x ULN at the time of first dose of recombinant Erwinia asparaginase administration\n* Creatinine clearance of ≥ 60 mL\u002Fmin per 24-hour urine test or the Cockcroft-Gault formula (within 14 days prior to day 1 of protocol therapy)\n* Prothrombin (PT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)\n* Activated partial thromboplastin time (aPTT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: Echocardiogram to be performed within 42 days prior to day 1 of protocol therapy\n* Seronegative for active hepatitis B virus (HBV) (surface antigen negative and anti-hepatitis B virus core antibody \\[HBc\\] negative) for CD20+ patients only\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 14 days prior to day 1 of protocol therapy)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective (non-hormonal) method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy. For participants taking rituximab, effective birth control or abstinence to be used for at least 12 months after last dose\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Leukemia-based therapy with chemotherapy with the exception of:\n\n  * Cytoreduction with steroid or hydroxyurea or a single dose of intrathecal chemotherapy is allowed before initiating the study\n  * Prior treatment with all-trans-retinoic acid (ATRA) for suspected acute promyelocytic leukemia (APL) is allowed\n* Received previous treatment with any other asparaginase formulation\n* Must not have received or planning to receive live vaccine while being on study or 2 weeks before and after completion of treatment. For CD20+ patients only: Must not have received any vaccines (live or non-live) 4 weeks before rituximab\n* Known presence of Philadelphia chromosome positive (Ph+; t\\[9;22\\])\n* Class III\u002FIV cardiovascular disability according to the New York Heart Association classification. Subjects with controlled, asymptomatic atrial fibrillation can enroll\n* Parenchymal central nervous system (CNS) involvement\n* Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of enrollment\n* History of acute cardiovascular ischemic event, i.e., myocardial infarction or unstable angina within 6 months of enrollment\n* History of intracranial thrombosis or history of recurrent thrombosis or grade 3 and greater pulmonary embolism (except for catheter-related thrombosis)\n* Participants with history of grade ≥ 3 pancreatitis\n* History of alcohol overuse if deemed relevant in investigator opinion\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Uncontrolled active infection\n* Clinically significant uncontrolled illness\n* Other active malignancy\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","54 Years",{"count":506,"type":22},53,[92],"This phase II trial tests the safety, side effects, and effectiveness of asparaginase Erwinia chrysanthemi during induction chemotherapy followed by consolidation chemotherapy in treating high-risk adults with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma. Asparaginase Erwinia chrysanthemi, a type of protein synthesis inhibitor, is a drug that is made up of the enzyme asparaginase, which comes from the bacterium Erwinia chrysanthemi, and is used with other drugs in people who cannot take asparaginase that comes from the bacterium E. coli. Asparaginase Erwinia chrysanthemi breaks down the amino acid asparagine and may stop the growth of cancer cells that need asparagine to grow. It may also kill cancer cells. Induction therapy, consisting of cytarabine, dexamethasone, vincristine, daunorubicin, methotrexate, and rituximab, is the first choice of treatment. Consolidation therapy, consisting of cyclophosphamide, cytarabine, vincristine, mercaptopurine, methotrexate and rituximab, is given after initial therapy to kill any remaining cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Cytarabine and mercaptopurine stop cells from making DNA and may kill cancer cells. They are a type of antimetabolite. Daunorubicin blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. It is a type of anthracycline antibiotic and a type of topoisomerase inhibitor. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving asparaginase Erwinia chrysanthemi with induction chemotherapy followed by consolidation chemotherapy may be safe, tolerable, and\u002For effective in treating high-risk adults with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma.",[510,35],"B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative","2026-03-16",{"date":513,"type":44},"2026-03-17",{"date":515,"type":44},"2025-10-10",{"date":517,"type":22},"2029-03-30",{"name":49,"class":50},8,{"id":521,"slug":522,"hasResults":11,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":23,"phases":528,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":402},"100532001","phase-1-a-study-to-investigate-lp-118-ponatinib-vincristine-and-dexamethasone-in-relapsedrefractory-acute-lymphoblastic-leukemia-all-or-lymphoblastic-lymphoma-lbl-100532001","NCT06207123","A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed\u002FRefractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL)","A Phase I\u002FII Study to Investigate the Combination of LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed\u002FRefractory T-ALL\u002FLBL","Inclusion Criteria:\n\n1. Relapsed or refractory patients with T-lineage acute lymphoblastic leukemia or T-lymphoblastic lymphoma\n2. 18 years old or older\n3. Bone marrow or peripheral blood involvement with ≥5% lymphoblasts or measurable residual disease with \\>10-4 level detected by multiparameter flow cytometry or next-generation sequencing (NGS)-based measurable residual disease (ClonoSEQ, Adaptive Technologies). Patients with isolated extramedullary disease that is measurable by computed tomography (CT) scan are also eligible.\n4. Eastern Cooperative Oncology Group performance status 0-2.\n5. Adequate organ function as defined by all of the following:\n\n   1. Creatinine clearance ≥50 mL\u002Fmin, determined by the Cockroft-Gault formula, or measured by a 24-hour urine collection.\n   2. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN) and bilirubin ≤1.5 x ULN (unless considered due to Gilbert's syndrome or of non-hepatic origin i.e,, leukemic involvement). For patients with Gilbert's syndrome, bilirubin ≤1.5 x of their baseline bilirubin level will be required.\n6. Participants must be at least 2 weeks from major surgery or radiation therapy. A wash-out period of 4 half-lives is required for patients who participated in other investigational trials. These patients must have recovered from clinically significant toxicities related to these prior treatments.\n7. Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)\u002FInstitutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.\n8. Females of childbearing potential will use effective contraception during protocol treatment and for at least 8 months after the last dose. Males with female partners of reproductive potential will use effective contraception during protocol treatment and for at least 5 months after the last dose. A patient is of childbearing potential if, in the opinion of the treating investigator, he\u002Fshe is biologically capable of having children and is sexually active. Female patients who are not of childbearing potential (ie, meet at least one of the following criteria):\n\n   a. Have undergone hysterectomy or bilateral oophorectomy; or have medically confirmed ovarian failure; or are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause).\n9. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Active central nervous system (CNS) leukemia\n2. Active or chronic hepatitis B or C infection as evidenced by hepatitis B surface antigen and anti-hepatitis C antibody positivity, respectively, or known seropositivity for human immunodeficiency virus (HIV). Patients with HIV but an undetectable viral load are eligible for enrollment.\n3. Major surgery within \\\u003C2 weeks before randomization.\n4. Unstable or severe uncontrolled medical condition (eg, unstable cardiac function or unstable pulmonary condition.\n5. Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or localized prostate cancer that has been definitely treated with radiation or surgery. Patients with previous malignancies are eligible provided that they have been disease free for ≥2 years or are not currently requiring treatment.\n6. Uncontrolled cardiac disease.\n7. Pregnant females; breastfeeding females; males with female partners of reproductive potential and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for a minimum of 5 months after the last dose of investigational product if male and 8 months after the last dose of investigational product if female.\n8. Participation in other investigational studies during active treatment phase.\n9. Other severe acute, chronic medical, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the treating physician, would make the patient inappropriate for entry into this study.",{"count":344,"type":22},[25,92],"The purpose of this study is to learn more about LP-118 (an experimental drug) and its side effects and decide on acceptable doses. The purpose of this study is to determine if LP-118 can be given safely with another medicine called ponatinib, that is FDA-approved for the treatment of acute lymphoblastic leukemia.",[130,531,35],"Lymphoblastic Leukemia",{"date":533,"type":44},"2026-03-18",{"date":535,"type":44},"2024-09-13",{"date":537,"type":22},"2026-12-01",{"name":539,"class":50},"University of Chicago",{"id":541,"slug":542,"hasResults":11,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":353,"enrollmentInfo":547,"targetDuration":4,"studyType":23,"phases":549,"briefSummary":550,"conditions":551,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":80},"100347932","cd45ra-depleted-peripheral-stem-cell-addback-for-viral-or-fungal-infections-post-tcrcd19-depleted-hsct-100347932","NCT03810196","CD45RA Depleted Peripheral Stem Cell Addback for Viral or Fungal Infections Post TCRαβ\u002FCD19 Depleted HSCT","CD45RA Depleted Peripheral Stem Cell Addback for Patients at Risk for Viral or Fungal Infections Post TCRαβ\u002FCD19 Depleted Hematopoietic Stem Cell Transplant","Inclusion Criteria:\n\n1. Age: Patients \\\u003C25 years.\n2. First allogeneic HSCT only.\n3. Disease eligibility: Acute leukemias at high risk for relapse including positive minimal residual disease at end consolidation, high risk cytogenetics, or relapse. Hematologic malignancies including: acute myeloid leukemia, myelodysplastic syndromes, acute lymphoblastic leukemia, mixed lineage or bi-phenotypic leukemia, lymphoblastic or Burkitts, juvenile myelomonocytic leukemia\n4. Evaluation of organ and infectious status as per our Bone Marrow Transplant standard operating procedure (BMT SOP).\n5. Signed consent by parent\u002Fguardian or able to give consent if \\>18 years.\n\nExclusion Criteria:\n\n1. Patients who do not meet institutional disease, organ or infectious criteria\n2. No suitable donor available for mobilized peripheral stem cells\n3. Patients with genetic disorders including Fanconi anemia, Kostmann syndrome, dyskeratosis congenital or other DNA repair defects.\n4. Patients with Hodgkin lymphoma or non-Burkitts, non-lymphoblastic lymphoma\n5. Pregnant Participants\n\nDonor selection and eligibility\n\n1. Unrelated donor meets National Marrow Donor Program criteria for donation\n2. HLA testing\u002Fmatching\n3. Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection",{"count":548,"type":22},50,[63],"The major morbidities of allogeneic hematopoietic stem cell transplant with non-human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life threatening infections. T depletion of the donor hematopoietic stem cell graft is effective in preventing GVHD, but immune reconstitution is slow, increasing the risk of infections. An addback of donor CD45RA (naive T cells) depleted cells may improve immune reconstitution and help decrease the risk of infections.",[130,30,552,29,553,35,144,147],"Myelodysplastic Syndromes","Mixed Lineage Leukemia","2026-02-18",{"date":556,"type":44},"2026-02-20",{"date":558,"type":44},"2019-03-01",{"date":560,"type":22},"2028-02",{"name":562,"class":50},"Children's Hospital of Philadelphia",{"id":564,"slug":565,"hasResults":11,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":11,"sex":17,"minAge":352,"maxAge":570,"enrollmentInfo":571,"targetDuration":4,"studyType":266,"phases":4,"briefSummary":573,"conditions":574,"keywords":580,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":600},"100611871","caya-cancer-retrospective-cohort-study-100611871","NCT07246213","CAYA Cancer Retrospective Cohort Study","Improving Cancer Outcomes for Children, Adolescents, and Young Adults: A Multicenter Retrospective Cohort Study on Treatment Failure and Toxicity in Low- and Middle-Income Countries","Inclusion Criteria:\n\nSubjects must meet all the following criteria to be included in this registry:\n\n1. Participants must be willing and able to provide informed consent prior to enrollment in the registry.\n\n   1. For minors or individuals unable to provide informed consent, assent must be obtained along with consent from a legal guardian.\n   2. Note: Exemption applies to this criterion when waiver of informed consent\u002Fassent is granted by Institutional Review Board(IRB)\u002FIndependent Ethics Committee(IEC)\u002FCompetent Authorities(CAs).\n2. A confirmed diagnosis of any type of cancer within the 15 years prior to the site's activation date.\n3. Age 0 to 21 years at the time of diagnosis.\n4. Received substantial anti-cancer treatment at the participating center, including but not limited to:\n\n   1. Chemotherapy\n   2. Surgery\n   3. Radiation therapy\n   4. Immunotherapy\n5. Medical records are available and accessible for review\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria will be excluded from this registry:\n\n  1. Patients who only visited the participating center for:\n\n     1. Consultation without subsequent primary anti-cancer treatment at the participating center\n     2. Pathology, radiology, or other diagnostic evaluations without treatment","21 Years",{"count":572,"type":22},18000,"Despite advances in cancer treatment, significant disparities in outcomes persist between high-income countries (HICs) and low-and middle-income countries (LMICs). Around 80% of children with cancer live in LMICs, where they face challenges such as delayed diagnosis, misdiagnosis, comorbidities, distance to treatment, financial barriers, and limited access to risk-adapted therapies.\n\nAcute lymphoblastic leukemia(ALL)\u002Flymphoblastic lymphoma(LBL), for example, is one of the greatest success stories in pediatric oncology, however, such improvements are not evenly distributed worldwide, and the outcomes for leukemia patients are poorer in LMICs compared to HICs, primarily due to reduced access to quality healthcare.\n\nThis study aims to assess cancer treatment outcomes in LMICs, focusing on acute lymphoblastic leukemia\u002Flymphoblastic lymphoma. The findings will inform future studies to implement evidence-based interventions that improve care quality and reduce treatment failures through targeted strategies.",[29,35,575,576,577,578,579],"Young Adult Cancer","Adolescent Cancer","Childhood Cancers","Acute Lymphoblastic Leukemia (ALL)","Lymphoblastic Lymphoma (LBL)",[581,582,583,584,585,586,587,588,589,590],"Cancer outcomes","Low- and Middle-Income Countries (LMICs)","Childhood cancer","Adolescent and young adult cancer (CAYA)","Treatment failure","Therapy-related toxicities","Retrospective cohort","Leukemia outcomes","Oncology disparities","High-Income Countries (HICs)","2025-12-12",{"date":593,"type":44},"2025-12-19",{"date":595,"type":44},"2025-06-04",{"date":597,"type":22},"2028-12-04",{"name":599,"class":50},"Resonance, Inc.",5,{"id":602,"slug":603,"hasResults":11,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":11,"sex":17,"minAge":326,"maxAge":570,"enrollmentInfo":608,"targetDuration":4,"studyType":23,"phases":610,"briefSummary":611,"conditions":612,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":625},"100475887","phase-1-tagraxofusp-in-pediatric-patients-with-relapsed-or-refractory-cd123-expressing-hematologic-malignancies-100475887","NCT05476770","Tagraxofusp in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies","A Phase I Study of Tagraxofusp With or Without Chemotherapy in Pediatric Patients With Relapsed or Refractory CD123 Expressing Hematologic Malignancies","Inclusion Criteria:\n\nAge\n\n* Patients must be ≥ 1 and ≤21 years of age at the time of study enrollment.\n\nDiagnosis\n\n* Relapsed and\u002For refractory hematologic malignancy (including, but not limited to, acute lymphoblastic leukemia, acute myeloid leukemia, myelodysplastic syndrome, mixed phenotype acute leukemia, acute undifferentiated leukemia, blastic plasmacytoid dendritic cell neoplasm, Hodgkin lymphoma, and non-Hodgkin lymphoma).\n* Tumor cells must demonstrate surface expression of CD123 at the time of enrollment by flow cytometry or immunohistochemistry, as defined by the local institution.\n\nDisease Status:\n\nMonotherapy, Part 1\n\n* Second or greater relapse; or\n* Refractory after 2 or more chemotherapy cycles; or\n* First relapse after primary chemotherapy-refractory disease; or\n* BPDCN in first relapse or refractory after 1 or more chemotherapy cycles\n\nCombination therapy, Part 2\n\n* First or greater relapse; or\n* Refractory after 2 or more chemotherapy cycles; or\n* BPDCN in first relapse or refractory after 1 or more chemotherapy cycles\n\nFor relapsed\u002Frefractory leukemia, patients must have:\n\n* \\>5% blasts in the bone marrow aspirate or biopsy by morphology or flow cytometry\n* Patients with 1% - 5% blasts are eligible for Part 2, Cohort C (only), if A single bone marrow sample with flow cytometry and at least one other test (e.g. karyotype, FISH, PCR, or NGS) shows ≥ 1% leukemic blasts and\u002For flow cytometry demonstrates a stable or rising level of disease on two serial bone marrows.\n\nFor relapsed\u002Frefractory non-Hodgkin or Hodgkin lymphoma, patients must have:\n\n* Histologic verification of relapse\n* Measurable disease documented by radiographic criteria or bone marrow\n* Patients in Part 1 may have sites of non-CNS extramedullary disease, but no CNS disease. Patients in Part 2 may have CNS disease and\u002For other non-CNS extramedullary disease. No cranial irradiation is allowed during the protocol therapy.\n* Patients with Down syndrome are eligible to participate in Part 1 only.\n\nPerformance Level\n\n* Karnofsky \\> 50% for patients \\> 16 years of age and Lansky \\> 50% for patients ≤ 16 years of age (See Appendix I for Performance Scales). Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n\nPrior Therapy\n\n* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy, defined as resolution of all such toxicities to ≤ Grade 2 or lower per the inclusion\u002Fexclusion criteria.\n\nMyelosuppressive chemotherapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. At least 14 day must have elapsed since the completion of myelosuppressive therapy. However, individuals may receive any of the following medications within 14 days without a \"wash-out period\":\n\n* Hydroxyurea: Hydroxyurea can be initiated and\u002For continued for up to 24 hours prior to the start of protocol therapy.\n* \"Maintenance-style\" therapy: therapy including vincristine (dosed a maximum of one-time weekly), oral 6-mercaptopurine, oral methotrexate (dosed a maximum of one-time weekly), intrathecal therapy (dosed a maximum of one-time weekly) and\u002For dexamethasone (dosed at ≤3 mg\u002Fm2\u002Fdose twice daily) or prednisone (dosed at ≤20 mg\u002Fm2\u002Fdose twice daily) can be continued for up to 24 hours prior to entering the study.\n* Hematopoietic stem cell transplant: Patients who have experienced their relapse after a HSCT are eligible, provided they have no evidence of acute or chronic Graft-versus-Host Disease (GVHD) and are at least 100 days post-transplant at the time of enrollment.\n* Hematopoietic growth factors: It must have been at least 7 days since the completion of therapy with granulocyte colony stimulating factor (GCSF) or other growth factors at the time of enrollment. It must have been at least 14 days since the completion of therapy with pegfilgrastim (Neulasta®).\n* Biologic (anti-neoplastic agent): At least 7 days after the last dose of a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.\n* Monoclonal antibodies: Maximum of 3 half-lives of the antibody or 21 days (whichever is shorter) must have elapsed after the last dose of monoclonal antibody.\n* Immunotherapy: At least 30 days from last infusion of chimeric antigen receptor T cell (CART) therapy or tumor vaccine.\n* Radiation Therapy (XRT):\n\n  1. ≥ 84 days must have passed, from the end of therapy, if patient received prior total body irradiation (TBI).\n  2. ≥ 42 days must have passed, from the end of therapy, if patient received craniospinal irradiation (CSI).\n  3. ≥ 14 days must have passed after whole brain radiotherapy or stereotactic radiation therapy.\n  4. No washout period is required for:\n\n  i. Extramedullary site other than CNS that is a maximum 10 x 10 cm total radiation non-CNS field. If the field is \\> 10 x 10 cm, a 14-day washout period is required. ii. Local ocular radiotherapy as long as subject has measurable\u002Fevaluable disease outside the radiation port.\n* Patients that have received other non-tagraxofusp CD123 targeting agents are eligible. Patients that have previously received tagraxofusp are not eligible.\n\nOrgan Function Requirements\n\nAdequate Bone Marrow Function Defined as:\n\n* Patients should not be known to be refractory to red blood cell or platelet transfusions.\n* Blood counts are not required to be normal prior to enrollment on trial. However, platelet count must be ≥20,000\u002Fmm3 to initiate therapy (may receive platelet transfusions).\n\nAdequate Renal Function Defined as:\n\n* Patient must have a calculated creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73m2 OR a normal serum creatinine based on age\u002Fgender in the chart below:\n\nMaximum Serum Creatinine (mg\u002FdL):\n\n* 1 to \\\u003C 2 years old - Male: 0.6, Female: 0.6\n* 2 to \\\u003C 6 years old - Male:0.8, Female: 0.8\n* 6 to \\\u003C 10 years old - Male: 1, Female: 1\n* 10 to \\\u003C 13 years old - Male: 1.2, Female: 1.2\n* 13 to \\\u003C 16 years old - Male: 1.5, Female: 1.4\n* ≥ 16 years old - Male: 1.7, Female: 1.4\n\nThe threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR (Schwartz et al. J. Peds, 106:522, 1985) utilizing child length and stature data published by the CDC.\n\nAdequate Liver Function Defined as:\n\n* Total bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x institutional upper limit of normal for age\n* SGPT (ALT) and SGOT (AST) must be less than 3x institutional upper limit of normal.\n* Serum albumin ≥3.2 g\u002FdL (albumin infusion independent).\n\nAdequate Cardiac Function Defined as:\n\n* Shortening fraction of ≥27% by echocardiogram, or\n* Ejection fraction of ≥ 50% by gated radionuclide study\u002Fechocardiogram.\n\nAdequate Pulmonary Function Defined as:\n\n* Pulse oximetry \\> 94% on room air (\\> 90% if at high altitude)\n* No evidence of dyspnea at rest and no exercise intolerance.\n\nReproductive Function\n\n* Female patients of childbearing potential must have a negative urine or serum pregnancy test confirmed within 2 weeks prior to enrollment.\n* Female patients with infants must agree not to breastfeed their infants while on this study.\n* Male and female patients of child-bearing potential must agree to use an effective method of contraception approved by the investigator during the study and for 12 weeks after the last dose of tagraxofusp.\n\nExclusion Criteria\n\nDisease Status:\n\n* Patients with CNS disease are not eligible for Part 1.\n* Patients with isolated CNS disease are not eligible for Part 1 or Part 2.\n* Patients with isolated non-CNS disease are eligible for Part 1 and Part 2.\n\nConcomitant Medications\n\n* Corticosteroids - Patients receiving corticosteroids for disease control who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible.\n* Investigational Drugs - Patients who are currently receiving another investigational drug are not eligible. The definition of \"investigational\" for use in this protocol means any drug that is not licensed by the FDA, Health Canada or the Therapeutic Goods Administration to be sold in the countries they govern. (United States, Canada and Australia)\n* Anti-cancer Agents - Patients who are currently receiving or may receive while on therapy, other anti-cancer agents, radiation therapy or immunotherapy are not eligible \\[with the exceptions being laid out in the inclusion criteria under 'Prior Therapy'\\]. Intrathecal chemotherapy (at the discretion of the primary oncologist) may be given up to one week prior to the initiation of study treatment (day 1 therapy).\n* Anti-GVHD or agents to prevent organ rejection post-transplant - Patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial. At least 4 weeks must have elapsed after the last dose of GVHD meds.\n\nInfection Criteria - Patients are excluded if they have:\n\n* Positive blood culture within 48 hours of study enrollment;\n* Fever above 38.2 within 48 hours of study enrollment with clinical signs of infection. Fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability.\n* A positive fungal culture within 30 days of study enrollment.\n* Active fungal, viral, bacterial, or protozoal infection requiring IV treatment. Chronic prophylaxis therapy to prevent infections is allowed.\n* Patients will be excluded if they have a known allergy to any of the drugs used in the study.\n* Patients will be excluded if they have significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with consent, study participation, follow up, or interpretation of study results.\n* Patients with DNA fragility syndromes (such as Fanconi anemia, Bloom syndrome) are excluded.",{"count":609,"type":22},54,[25],"Tagraxofusp is a protein-drug conjugate consisting of a diphtheria toxin redirected to target CD123 has been approved for treatment in pediatric and adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN). This trial aims to examine the safety of this novel agent in pediatric patients with relapsed\u002Frefractory hematologic malignancies.\n\nThe mechanism by which tagraxofusp kills cells is distinct from that of conventional chemotherapy. Tagraxofusp directly targets CD123 that is present on tumor cells, but is expressed at lower or levels or absent on normal hematopoietic stem cells. Tagraxofusp also utilizes a payload that is not cell cycle dependent, making it effective against both highly proliferative tumor cells and also quiescent tumor cells.\n\nThe rationale for clinical development of tagraxofusp for pediatric patients with hematologic malignancies is based on the ubiquitous and high expression of CD123 on many of these diseases, as well as the highly potent preclinical activity and robust clinical responsiveness in adults observed to date.\n\nThis trial includes two parts: a monotherapy phase and a combination chemotherapy phase. This design will provide further monotherapy safety data and confirm the FDA approved pediatric dose, as well as provide safety data when combined with chemotherapy.\n\nThe goal of this study is to improve survival rates in children and young adults with relapsed hematological malignancies, determine the recommended phase 2 dose (RP2D) of tagraxofusp given alone and in combination with chemotherapy, as well as to describe the toxicities, pharmacokinetics, and pharmacodynamic properties of tagraxofusp in pediatric patients.\n\nAbout 54 children and young adults will participate in this study. Patients with Down syndrome will be included in part 1 of the study.",[460,153,17,613,154,35,614,615,34,243,301],"BPDCN","Lymphoma, B-Cell","Lymphoma, T-Cell","2024-12-04",{"date":618,"type":44},"2024-12-06",{"date":620,"type":44},"2022-11-11",{"date":622,"type":22},"2027-11-11",{"name":624,"class":50},"Therapeutic Advances in Childhood Leukemia Consortium",31,{"id":627,"slug":628,"hasResults":11,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":632,"eligibilityCriteria":633,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":634,"targetDuration":4,"studyType":23,"phases":636,"briefSummary":637,"conditions":638,"keywords":642,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":80},"100555131","phase-2-vitamin-a-and-d-supplementation-in-allogeneic-hct-100555131","NCT06508099","Vitamin A and D Supplementation in Allogeneic HCT","Randomized Study of Vitamin A and D Prophylaxis Before Allogeneic Related and Unrelated Hematopoietic Stem Cell Transplantation","VitaStem","Inclusion Criteria:\n\n* Diagnosis: acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myeloproliferative disease, chronic myeloid leukemia, lymphoblastic lymphoma, myeloma\n* Standard disease risk: less than 5% clonal blasts in the bone marrow and the absence of blast forms in the peripheral blood at the time of inclusion in the study or at least partial response for lymphoproliferative neoplasms.\n* Related compatible donor 10\u002F10 HLA-matched or unrelated compatible donor 9-10\u002F10 HLA-matched\n* Age ≥18 years\n* Absence of severe concomitant somatic diseases\n\nExclusion Criteria:\n\n* \\- Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 normal;\n* respiratory failure more than 1 degree. or oxygen dependence\n* Unstable hemodynamics;\n* Uncontrolled bacterial or fungal infection at the time of inclusion, despite adequate antibacterial or antifungal therapy (CRP\\>70 mg\u002Fl at the time of inclusion).\n* Karnofsky index less than 70%\n* Repeated allogeneic transplantation of hematopoietic cells;\n* Creatinine clearance below 60ml\u002Fmin\u002F1.73m2;\n* Severe cardiac pathology, including a decrease in ejection fraction less than \\\u003C50%, unstable angina, exertional angina of III-IV functional class, heart failure of III-IV functional class, arrhythmia grade V according to Lawn\n* Severe decrease in lung function, FEV1 \\\u003C50% or DLCO\\\u003C50% predicted\n* Pregnancy\n* Somatic or mental pathology that does not allow signing informed consent",{"count":635,"type":22},220,[92],"The therapy under investigation is the addition of 300 000 IU of vitamin A and 100 000 IU of vitamin D before conditioning. The study will include patients with malignant diseases in hematologic response with indications for allogeneic transplantation with matched related or matched unrelated donor.",[29,30,363,35,639,552,640,641],"Chronic Myeloid Leukemia","Myeloprolipherative Neoplsm","Non-hodgkin Lymphoma",[643,644,645],"allogeneic hematopoietic transplantation","vitamin A","vitamin D","2024-07-29",{"date":648,"type":44},"2024-07-31",{"date":650,"type":44},"2024-05-15",{"date":652,"type":22},"2027-05",{"name":654,"class":50},"St. Petersburg State Pavlov Medical University",{"id":656,"slug":657,"hasResults":11,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":662,"targetDuration":4,"studyType":23,"phases":663,"briefSummary":664,"conditions":665,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":666,"lastUpdatePostDateStruct":667,"startDateStruct":669,"completionDateStruct":670,"leadSponsor":672,"locationsCount":80},"100552781","phase-2-beflubu-vs-fluburux-conditioning-in-haploidentical-hct-100552781","NCT06477549","BeFluBu vs FluBuRux Conditioning in Haploidentical HCT","Randomized Trial of Benadamustine Versus Ruxolitinib With Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation","Inclusion Criteria:\n\n* Patients must have an indication for allogeneic hematopoietic stem cell transplantation with myeloablative conditioning for malignant disease\n* Diagnosis: acute myeloid leukemia, acute lymphoblastic leukemia, mixed lineage acute leukemia, lymphoblastic lymphoma, chronic myeloid leukemia, myelodysplastic syndromes, myeloprolipherative neoplasm\n* Age ≥18\n* Malignant disease in hematologic response: \\\u003C5% of clonal blasts in the bone marrow and no clonal blasts in peripheral blood.\n* Patients with 5-9\u002F10 HLA-matched related donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.\n* Peripheral blood stem cells or bone marrow as a graft source\n\nExclusion Criteria:\n\n* Titer of anti-donor anti-HLA antibodies ≥ 5000 at the time of inclusion\n* Moderate or severe cardiac disease: ejection fraction \\\u003C50%, unstable angina, stable angina NYHA class III or IV, chronic heart failure NYHA class III or IV, Lawn grade V arrhythmia, myocardial infarction within 3 months before inclusion\n* Stroke within 3 months of inclusion, unless related to the underlying malignancy\n* Severe decrease in pulmonary function: FEV1 \\\u003C50% or DLCO\\\u003C50% of predicted or respiratory distress or need for oxygen support;\n* Severe organ dysfunction: AST or ALT \\>5 upper normal limits, bilirubin \\>1.5 upper normal limits, creatinine \\>2 upper normal limits\n* Creatinine clearance \\\u003C 40 mL\u002Fmin\n* Uncontrolled bacterial or fungal infection at the time of enrollment defined by CRP\\> 70 mg\u002FL\n* Requirement for vasopressor support at the time of enrollment\n* Karnofsky index \\\u003C70%\n* Pregnancy\n* Somatic or psychiatric disorder making the patient unable to sign informed consent",{"count":635,"type":22},[92],"Haploidentical hematopoietic stem cell transplantation irrespective of the conditioning intensity and graft-versus-host disease prophylaxis is associated with high frequency of primary and secondary graft failure. Different technologies of with replete or depleted graft are associated with 7-20% of graft failures in different diseases. Fludarabine and busulfan conditioning is the most commonly used approach for a variety of diseases. In two previously completed trials of addition of either bendamustine and ruxolitinib to conditioning we observed low rates of primary graft failure with both approaches. The study is the direct randomized comparisons of these two approaches with the primary aim of reducing composite events of primary graft failure, relapse and non-relapse mortality. The stratas for the study are Disease Risk Index (DRI) and the age of the haploidentical donor (\\\u003C35 vs ≥35).",[29,30,363,35,38,552],"2024-06-21",{"date":668,"type":44},"2024-06-27",{"date":666,"type":44},{"date":671,"type":22},"2029-06",{"name":654,"class":50}]