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Cord blood transplantation

cyclophosphamide

cytarabine

Hisashi Sakamaki, M.D., Ph.D.

The primary purpose of this study is to evaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies including refractory acute leukemia. The transplant procedure was determined in detail according to the previously published report showing a high survival, so that the investigators could expect a similar result.

Although cord blood is considered as an alternative donor source for allogeneic hematopoietic stem cell transplantation, its procedure has yet to be standardized. Recently, a single institute result of cord blood transplantation for adult patients with hematologic malignancies have been reported by Takahashi et al (Blood 2004:104;3813-3820), in which the survival was significantly better than that of bone marrow transplantation from unrelated donor. The purpose of this study was to reevaluate the safety and efficacy of cord blood transplantation for adult patients with hematologic malignancies using the same transplant procedures in a multi-institutional setting.

Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies

Phase 1/2 Study of Cord Blood Transplantation From Unrelated Donor for Adult Patients With Hematologic Malignancies Using Myeloablative Conditioning Regimen

Keio University

Pathologic Complete Response

Disease Progression

Dermatologic Agents

Reproductive Control Agents

Micronutrients

Hematinics

Vitamins

Tacrolimus

Etoposide

Fludarabine

Fludarabine phosphate

Methotrexate

Etoposide phosphate

Busulfan

Calcineurin Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Peripheral blood matched related donor HCT, using myeloablative conditioning regimen (IV Busulfan/IV Fludarabine for AML, IV VP16/TBI for ALL) HCT with cyclophosphamide, and oral tacrolimus (or another calcineurin inhibitor if intolerant for tacrolimus) for GVHD prophylaxis. Cyclophosphamide will be given at a dose of 50 mg/kg/day IV on Day +3 and Day +5 post stem cell infusion (only 2 doses).

Peripheral blood matched related donor HCT, using myeloablative conditioning regimen (IV Busulfan/IV Fludarabine for AML, IV VP16/TBI for ALL) HCT with methotrexate, and oral tacrolimus (or another calcineurin inhibitor if intolerant for tacrolimus) for GVHD prophylaxis

Cyclophosphamide as GVHD prophylaxis will be on day +3 and day +5

Cyclophosphamide 50mg

Methotrexate as GVHD prophylaxis will be on day +1, day +3, and day +6

Riad O El Fakih, MD

Mahmoud D Aljurf, MD, MPH

Marwan Y Shaheen, MD

This randomized clinical trial will evaluate two approaches of GvHD prophylaxis; the standard of care GVHD prophylaxis regimen (methotrexate/calcineurin inhibitors) and post-transplant cyclophosphamide with calcineurin inhibitors for their efficacy as a new GVHD prophylaxis strategy.

An open-label randomized clinical trial will be performed. Eligible patients are females and males, between 14 and 65 years undergoing allo-HCT for treatment of Acute Leukemia (AML or ALL). Patients must have a matching related peripheral blood stem cell donor. Patients from or referred to the KFSH\&RC for allogeneic transplant consideration will be offered the opportunity to participate in this trial.

Treatment Description:

Patients will be randomized on one of the arms; an intervention or a standard of care arm.

Comparing Post-Transplant Cyclophosphamide as GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients

Comparing Post-Transplant Cyclophosphamide With Calcineurin Inhibitors as A GVHD Prophylaxis to Standard Care of Methotrexate and Calcineurin Inhibitors for Acute Leukemia Incorporating Patient Pharmacogenomics Profiling

Defined as the non-occurrence of a grade 3-4 acute GVHD, or systemic therapy-requiring chronic GVHD, or relapse, or death during the first post-transplant year.

The probabilities of grade II-IV and III-IV acute GVHD will be determined. Acute GVHD will be graded according to Glucksberg and NIH 2014 criteria.

The cumulative incidence of systemic therapy-requiring chronic GVHD will be determined. Moderate and severe chronic GVHD will be defined per the NIH 2014 criteria.

King Faisal Specialist Hospital & Research Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies	NCT00270881	Acute Myelogeno... Acute Lymphobla... Chronic Myeloge... Myelodysplastic...	Cord blood tran... TBI cyclophosphamid... cytarabine	20 Years - 55 Years	Keio University
Comparing Post-Transplant Cyclophosphamide as GVHD Prophylaxis to Standard of Care for Acute Leukemia Patients	NCT04314219	Acute Lymphobla... Acute Myeloid L...	Cyclophosphamid... Methotrexate	14 Years - 65 Years	King Faisal Specialist Hospital & Research Center
Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies	NCT00270881	Acute Myelogeno... Acute Lymphobla... Chronic Myeloge... Myelodysplastic...	Cord blood tran... TBI cyclophosphamid... cytarabine	20 Years - 55 Years	Keio University
Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies	NCT00270881	Acute Myelogeno... Acute Lymphobla... Chronic Myeloge... Myelodysplastic...	Cord blood tran... TBI cyclophosphamid... cytarabine	20 Years - 55 Years	Keio University
Safety and Efficacy of Unrelated Cord Blood Transplantation for Adult Patients With Hematologic Malignancies	NCT00270881	Acute Myelogeno... Acute Lymphobla... Chronic Myeloge... Myelodysplastic...	Cord blood tran... TBI cyclophosphamid... cytarabine	20 Years - 55 Years	Keio University

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