[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"burkitt-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:burkitt-leukemia":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,58],{"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":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"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",false,"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).",true,"ALL","6 Months","26 Years",{"count":21,"type":22},68,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","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.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Acute Biphenotypic Leukemia","Acute Leukemia","Acute Leukemia of Ambiguous Lineage","Acute Lymphoblastic Leukemia","Acute Undifferentiated Leukemia","Allogeneic Hematopoietic Stem Cell Transplantation Recipient","Blastic Plasmacytoid Dendritic Cell Neoplasm","Blasts Under 25 Percent of Bone Marrow Nucleated Cells","Blasts Under 5 Percent of Bone Marrow Nucleated Cells","Mixed Phenotype Acute Leukemia","Myelodysplastic Syndrome With Excess Blasts-1","Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Burkitt Leukemia","Chronic Monocytic Leukemia","Lymphoblastic Lymphoma","Mast Cell Leukemia","Myeloproliferative Neoplasm","RECRUITING","2026-05-11",{"date":48,"type":49},"2026-05-14","ACTUAL",{"date":51,"type":49},"2019-08-29",{"date":53,"type":22},"2028-12-31",{"name":55,"class":56},"Fred Hutchinson Cancer Center","OTHER",10,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":23,"phases":69,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"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":68,"type":22},40,[70],"NA","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",[73,74,75,76,77,78,79,80,42,81,40,82,83],"Leukemia","Acute Myeloid Leukemia in Remission","Myelodysplasia","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","Burkitt Lymphoma","Lymphoma After Relapse","Other Malignant Hematologic Diseases in Remission","2026-05-08",{"date":86,"type":49},"2026-05-13",{"date":88,"type":49},"2023-05-01",{"date":90,"type":22},"2032-05",{"name":92,"class":56},"Medical College of Wisconsin",1]