Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation
Complete Title: A Randomized Phase II Study to Compare the Net Clinical Benefit of Cyclosporine and Sirolimus combined with MMF or Post-Transplant Cyclophosphamide as GVHD Prophylaxis after HLA-Matched or HLA-Mismatched Unrelated G-CSF Mobilized Blood Cell Transplantation using Nonmyeloablative or Reduced Intensity Conditioning for Patients with Hematologic Malignancies: A Multi-Center Trial
Trial Phase: II
Investigator: Masumi Ueda Oshima
This randomized phase II trial includes a blood stem cell transplant from an unrelated donor to treat blood cancer. The treatment also includes chemotherapy drugs, but in lower doses than conventional (standard) stem cell transplants. The researchers will compare two different drug combinations used to reduce the risk of a common but serious complication called "graft versus host disease" (GVHD) following the transplant. Two drugs, cyclosporine (CSP) and sirolimus (SIR), will be combined with either mycophenolate mofetil (MMF) or post-transplant cyclophosphamide (PTCy). This part of the transplant procedure is the main research focus of the study.
Keywords:
Leukemia, Acute Lymphoblastic (ALL)
Leukemia, Acute Myeloid (AML)
Leukemia, Chronic Lymphocytic (CLL)
Hematologic Malignancies
Lymphoma, Hodgkin
Leukemia
Lymphoma
Lymphoproliferative Disorders
Pediatric Cancers, Miscellaneous
Multiple Myeloma (MM)
Myelodysplastic Syndromes (MDS)
Lymphoma, Non-Hodgkin (NHL)
Leukemia, Myeloid
Leukemia, Lymphoid
Immunoproliferative Disorders
Hematopoietic Cell Transplantation (HCT)
Myeloproliferative Disorders (MPD)
Myelodysplastic-Myeloproliferative Diseases
Waldenstrom Macroglobulinemia
Lymphoma, Mantle-Cell
Lymphoma, B-Cell
Lymphoma, Small Lymphocytic (SLL)
Leukemia, Prolymphocytic
Bone Marrow Diseases
Leukemia, Chronic Myelogenous
Neoplasms, Plasma Cell
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immune System Diseases
Plasma Cell Myeloma
Hematologic Diseases
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Adult
Pediatric
II
Masumi Ueda Oshima
9816
NCT03246906
A Randomized Phase II Study to Compare the Net Clinical Benefit of Cyclosporine and Sirolimus combined with MMF or Post-Transplant Cyclophosphamide as GVHD Prophylaxis after HLA-Matched or HLA-Mismatched Unrelated G-CSF Mobilized Blood Cell Transplantation using Nonmyeloablative or Reduced Intensity Conditioning for Patients with Hematologic Malignancies: A Multi-Center Trial