Spots Global Cancer Trial Database for HLA-mismatched MST vs HLA-matched NST for AML in Intermediate-risk

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Trial Identification

Brief Title: HLA-mismatched MST vs HLA-matched NST for AML in Intermediate-risk

Official Title: Compare the Safety and Effective of HLA-mismatched Microtransplantation With HLA-matched Nonmyeloablative Transplantation for Acute Myeloid Leukemia in Intermediate-risk

Study ID: NCT02461121

Conditions

Acute Myeloid Leukemia

Interventions

HLA mismatched stem cell

HLA matched stem cell

cyclosporine A

Mycophenolate mofetil

Ara-C

fludarabine

anti-lymphocyte globulin

cyclophosphamide

Study Description

Brief Summary: Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.

Detailed Description: The optimal therapy for intermediate-risk patients with acute myeloid leukemia (AML) in first complete remission (CR1) is uncertain. Recent studies shown that microtransplantation (MST) can improve survival in AML-CR1 patients. However, a comparison study between the MST and nonmyeloablative stem cell transplantation (NST) is lacking. 156 intermediate-risk AML-CR1 patients aged 9 to 59 years were enrolled in this study. Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.