Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Myelodysplastic/Myeloproliferative Neoplasm
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Aggressive Non-Hodgkin Lymphoma
- Recurrent Plasma Cell Myeloma
- Blastic Plasmacytoid Dendritic Cell Neoplasm
- Chronic Lymphocytic Leukemia
- Diffuse Large B Cell Lymphoma
- Recurrent Chronic Lymphocytic Leukemia
- Hematologic and Lymphocytic Disorder
- Recurrent Hodgkin Lymphoma
- Mantle Cell Lymphoma
- Recurrent Small Lymphocytic Lymphoma
- Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Recurrent Waldenstrom Macroglobulinemia
- Myelodysplastic Syndrome
- Prolymphocytic Leukemia
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Compare chronic graft versus host disease (GVHD)-free and relapse-free survival (CRFS) after transplant between the 2 GVHD prophylaxis regimens. SECONDARY OBJECTIVES: I. Compare rates of acute (grades II-IV and III-IV) and moderate and severe chronic GVHD (based on National In...
PRIMARY OBJECTIVES: I. Compare chronic graft versus host disease (GVHD)-free and relapse-free survival (CRFS) after transplant between the 2 GVHD prophylaxis regimens. SECONDARY OBJECTIVES: I. Compare rates of acute (grades II-IV and III-IV) and moderate and severe chronic GVHD (based on National Institutes of Health [NIH] consensus criteria), relapse, non-relapse mortality, progression or relapse-free survival, and overall survival between the 2 regimens. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo allogeneic hematopoietic stem cell transplant (HCT) at day 0. Patients with an HLA-matched unrelated donor receive mycophenolate mofetil orally (PO) on days 0 to 40, cyclosporine PO every 12 hours twice daily (BID) on days -3 to 96 then tapered to day 150, and sirolimus PO once daily (QD) on days -3 to day 150 then tapered to day 180. Patients with an HLA-mismatched donor receive mycophenolate mofetil PO on days 0-100 then tapered to day 150, cyclosporine PO BID on days -3 to 150 then tapered to day 180, and sirolimus PO QD on days -3 to 180 then tapered to day 365. ARM II: Patients undergo HCT at day 0. Patients with an HLA-matched unrelated donor receive cyclosporine PO BID on days 5-96 then tapered to day 150, sirolimus PO QD on days 5-150 then tapered to day 180, and cyclophosphamide intravenously (IV) on days 3 and 4. Patients with an HLA-mismatched donor receive cyclosporine PO BID on days 5-150 then tapered to day 180, sirolimus PO QD on days 5-180 then tapered to day 365, and cyclophosphamide IV on days 3 and 4. After completion of study treatment, patients are followed up at 6 months and every year thereafter.
Tracking Information
- NCT #
- NCT03246906
- Collaborators
- National Cancer Institute (NCI)
- National Institutes of Health (NIH)
- Investigators
- Principal Investigator: Masumi Ueda Oshima Fred Hutch/University of Washington Cancer Consortium