[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464386":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":62,"centralContacts":67,"locations":76,"responsibleParty":95,"collaborators":12,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":12,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":12,"studyType":111,"phases":112,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":79,"whyStopped":12,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,13,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Donor Arm","NO_INTERVENTION","Donors for Recipients in Arms 1-4",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Phase I Dose Escalation, Cohort 1 (matched)","EXPERIMENTAL","DLI at escalating doses (1 x 10\\^6 CD3+ cells\u002Fkg, 3 x 10\\^6 CD3+ cells\u002Fkg, and 1 x 10\\^7 CD3+ cells\u002Fkg) on day +7 or +21 to assess for safety and determine Phase II dose (up to 18 evaluable patients)",[18,19,20,21,22,23],"Procedure: donor lymphocyte infusion","Drug: Cyclophosphamide","Drug: Busulfan","Drug: Mycophenolate mofetil","Drug: Fludarabine","Drug: Sirolimus",{"label":25,"type":15,"description":26,"interventionNames":27},"Phase I Dose Escalation, Cohort 2 (haploidentical)","DLI at escalating doses (1 x 10\\^5 CD3+ cells\u002Fkg, 3 x 10\\^5 CD3+ cells\u002Fkg, and 1 x 10\\^6 CD3+ cells\u002Fkg) on day +7 or +21 to assess for safety and determine Phase II dose (up to 18 evaluable patients)",[18,19,20,21,22,23],{"label":29,"type":15,"description":30,"interventionNames":31},"Phase II Efficacy, Cohort 1 (matched)","DLI at maximally tolerated, safe dose (from Phase I) to assess secondary clinical outcomes at this dosing level (up to 14 additional evaluable patients in each cohort)",[18,19,20,21,22,23],{"label":33,"type":15,"description":30,"interventionNames":34},"Phase II Efficacy, Cohort 2 (haploidentical)",[18,19,20,21,22,23],[36,41,46,50,54,58],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":12},"PROCEDURE","donor lymphocyte infusion","The DLI will be given on Day +7 (Day +21 for dose level -1). If a recipient participant is deemed too critically ill\u002Funstable to receive DLI on the protocol specified day, the DLI will be delayed up to 4 days at the discretion of the PI and given within this time frame once the recipient participant s clinical status has stabilized or improved. If the DLI cannot be given during this time frame, the recipient participant will be taken off study and not considered evaluable for DLT, outcomes, or adverse events since the experimental intervention will not have been given.",[14,25,29,33],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":12},"DRUG","Cyclophosphamide","HLA-matched: 50 mg\u002Fkg IV once daily over 2 hours on days +3 and +4a Cyclophosphamide will be dosed according to ideal body weight. HLA haploidentical: 25 mg\u002Fkg IV once daily over 2 hours on days +3 and +4a Cyclophosphamide will be dosed according to ideal body weight.",[14,25,29,33],{"type":42,"name":47,"description":48,"armGroupLabels":49,"otherNames":12},"Busulfan","AUC targeted dose based on busulfan test dose, with a default dose of 130 mg\u002Fm2\u002Fday, given as IV infusion over 3 hours each day for 4 days Transplant days -6 through day -3",[14,25,29,33],{"type":42,"name":51,"description":52,"armGroupLabels":53,"otherNames":12},"Mycophenolate mofetil","15 mg\u002Fkg orally or IV three times daily (max 1000 mg\u002Fdose) starting on day +5, continued through day +35. Dosing will be according to actual body weight.",[14,25,29,33],{"type":42,"name":55,"description":56,"armGroupLabels":57,"otherNames":12},"Fludarabine","40 mg\u002Fm2 IV infusion over 30-60 minutes once daily for 4 days Transplant days -6 through -3",[14,25,29,33],{"type":42,"name":59,"description":60,"armGroupLabels":61,"otherNames":12},"Sirolimus","Loading dose of 6 mg orally given on day +5 (calculated based on actual body weight, maximum initial dose 6 mg), then maintenance dose starting at 2 mg orally daily on day +6 with dose adjustments to maintain a trough of 5-12 ng\u002Fml, continued through day +70 with no taper. Doses should be modified as appropriate for drug interactions.",[14,25,29,33],[63],{"name":64,"affiliation":65,"role":66},"Christopher G Kanakry, M.D.","National Cancer Institute (NCI)","PRINCIPAL_INVESTIGATOR",[68,73],{"name":69,"role":70,"phone":71,"phoneExt":12,"email":72},"Amy H Chai","CONTACT","(240) 858-3755","amy.chai@nih.gov",{"name":64,"role":70,"phone":74,"phoneExt":12,"email":75},"(240) 760-6171","christopher.kanakry@nih.gov",[77],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":86,"coordinates":87},"Point",[88,89],-77.10026,38.98067,{"lat":89,"lon":88},[92],{"name":93,"role":70,"phone":94,"phoneExt":12,"email":12},"For more information at the NIH Clinical Center contact National Cancer Institute Referral Office","888-624-1937",{"type":96,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100464386","phase-1-donor-lymphocyte-infusion-after-allogeneic-hematopoietic-cell-transplantation-for-high-risk-hematologic-malignancies-100464386",false,"NCT05327023","Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies","Phase I\u002FII Study Using Prophylactic Donor Lymphocyte Infusion Early Post-Transplant After Allogeneic Hematopoietic Cell Transplantation Using Post-Transplantation Cyclophosphamide for High-Risk Hematologic Malignancies","* INCLUSION CRITERIA:\n\nInclusion Criteria - Recipient\n\n* Histologically or cytologically confirmed hematologic malignancy classified as high or very high disease risk by the Refined Disease Risk Index for HCT including one of the following:\n* Acute myeloid leukemia (AML) with favorable cytogenetics (t(8;21), inv(16), t(15,17)) with induction failure (persistent disease without first achieving remission of any type) or active relapse\n* AML with intermediate cytogenetics (not classified as favorable or adverse) with induction failure or active relapse (AML with intermediate cytogenetics in morphologic complete remission \\[CR\\] with minimal residual disease detectable by any modality also will be eligible)\n* AML with adverse cytogenetics (complex karyotype with \\>= 4 abnormalities) regardless of remission status\n* Low risk myelodysplastic syndrome (MDS) (\\\u003C= 5% blasts, including chronic myelomonocytic leukemia) with adverse cytogenetics (abnormal chromosome 7 or \\>= 4 abnormalities) with induction failure or active relapse\n* High risk MDS (RAEB-1 or RAEB-2) with intermediate-risk cytogenetics (no abnormal chromosome 7 or \\\u003C 4 abnormalities) with induction failure or active relapse\n* High risk MDS (RAEB-1 or RAEB-2) with adverse cytogenetics (abnormal chromosome 7 or \\>= 4 abnormalities) regardless of remission status\n* Acute lymphoblastic leukemia (ALL) in CR \\>= 2 or with induction failure or active relapse (ALL in CR1 with minimal residual disease detected also will be eligible)\n* Chronic myelocytic leukemia (CML) in blast crisis phase\n* Hodgkin lymphoma with stable or progressive disease\n* Mantle cell lymphoma with stable or progressive disease\n* Relapsed Burkitt lymphoma in CR or partial remission (PR)\n* Aggressive B-cell Non-Hodgkin Lymphoma (NHL) (e.g., diffuse large B-cell lymphoma, transformed indolent B-cell lymphoma) with stable or progressive disease\n* T-cell NHL with stable or progressive disease\n* Multiple myeloma (MM) with induction failure as defined by failure to achieve minimal response (CR, Very Good Partial Response \\[VGPR\\], or PR) or the development of progressive disease on primary therapy, or MM with active relapse as defined by previously treated myeloma that achieved a molecular response or better that then progressed\n* Age 18-65 years.\n* At least one potentially suitable HLA-haploidentical or HLA-matched donor\n* Karnofsky performance score \\>=60%\n* Recipient participants must have adequate organ function as defined below:\n* Cardiac ejection fraction \\>=45% by 2D ECHO;\n* Forced expiratory volume-1 (FEV-1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) all of \\>=50% predicted;\n* Estimated serum creatinine clearance of \\>=60 ml\u002Fminute\u002F1.73m2 calculated using eGFR in the clinical lab;\n* Total bilirubin \\\u003C=2X the upper limit of normal;\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C=3X the upper limit of normal.\n* Myeloablative conditioning is toxic to the developing human fetus and is teratogenic. For this reason, the following measures apply:\n* Women of child-bearing potential (WOCBP) and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one-year post-transplant.\n* WOCBP must have a negative serum or urine pregnancy test within 7 days prior to enrollment.\n\nInclusion Criteria - Donor\n\n-Related donor (age \\>=12) deemed suitable, eligible, and willing to donate, per clinical evaluations, who are additionally willing to donate blood, bone marrow, and stool for research. Related donors will be evaluated in accordance with existing Standard Policies and Procedures for determination of eligibility and suitability for clinical donation.\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria - Recipient\n\n* Subjects who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 3 weeks prior to the date of beginning conditioning.\n* Prior myeloablative conditioning for autologous or allogeneic HCT.\n* Active breastfeeding.\n* Active malignancy of non-hematopoietic type (excluding non-melanoma skin cancers) which is metastatic, relapsed\u002Frefractory to treatment, or locally advanced and not amenable to curative treatment. This excludes non-melanoma skin cancers.\n* Uncontrolled intercurrent illness (e.g. severe endocrinopathy, disseminated intravascular coagulation, profound electrolyte disturbance, active hepatitis, uncontrolled dental infection) that in the opinion of the PI would make it unsafe to proceed with transplantation.\n\nExclusion Criteria - Donor\n\nNone.",true,"ALL","12 Years","120 Years",{"count":109,"type":110},430,"ESTIMATED","INTERVENTIONAL",[113,114],"PHASE1","PHASE2","Background:\n\nPeople with blood cancers often receive blood or bone marrow transplants. But even with these treatments, the risk of relapse is high. Researchers want to see if giving the transplant recipient an infusion of lymphocytes (a type of white blood cell) from their transplant donor early after the transplant can reduce that risk.\n\nObjective:\n\nTo learn if giving donor lymphocytes early after a transplant will help reduce the risk of relapse for people with certain blood cancers.\n\nEligibility:\n\nAdults aged 18-65 with high-risk leukemia, lymphoma, myelodysplastic syndrome, or multiple myeloma that does not respond well to standard treatments and\u002For has a high risk of relapse. Healthy potential bone marrow and lymphocyte donor relatives aged 12 and older are also needed.\n\nDesign:\n\nParticipants will be screened with:\n\nPhysical exam\n\nBlood and urine tests\n\nSpinal tap\n\nEye exam\n\nDental exam\n\nHeart and lung tests\n\nImaging scans. A radioactive substance may be injected in their arm if a PET scan is needed.\n\nBone marrow aspiration and biopsy\n\nSome screening tests will be repeated during the study.\n\nParticipants will stay at the NIH hospital for about 4 weeks. They will receive a central venous catheter. They will get chemotherapy and other drugs starting 6 days before transplant. Then they will have their transplant. They will receive donor white blood cells 7 days later. They will give blood, bone marrow, urine, and stool samples for research. They must stay near NIH for at least 100 days after transplant.\n\nParticipants will have periodic follow-up visits for 5 years.\n\nHealthy donors will have 2-3 visits. They will give blood, bone marrow, white blood cells, and stool samples for research.\n\nParticipation will last for 5 years....",[117],"Hematologic Neoplasms",[119,120,121,122,123],"Prophylactic Donor Lymphocyte Infusions","Chronic Graft-Versus-Host Disease","Immunotherapeutic Strategies","myeloablative conditioning","Steroid-Refractory Grade","2026-06-04",{"date":126,"type":127},"2026-06-05","ACTUAL",{"date":129,"type":127},"2022-05-23",{"date":131,"type":110},"2029-07-02",{"name":65,"class":6},1]