Acute Myeloid Leukemia (AML) Clinical Trial
Official title:
Phase II Study of 5-azacytidine Maintenance After Allogeneic Hematopoietic Cell Transplantation for High-risk Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Despite improvements in outcomes after Hematopoietic Cell Transplantation (HCT) for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), the risk of relapse remains high and is the most common cause of mortality after HCT. Moreover, treatment options for relapse after HCT are limited. Strategies to reduce relapse with maintenance therapy in patients who are at high risk are needed to improve survival. 5-aza is a hypomethylating agent that has shown immune modulating properties that may enhance the graft-versus-leukemia (GVL) effect, including upregulation of tumor-associated antigen and costimulatory molecule expression. Moreover, 5-aza has properties that suggest protection against graft-versus-host disease (GVHD) as well. Preliminary data shows that it is well tolerated and effective in clinical use for the treatment of AML or MDS relapse after HCT, as well as for maintenance therapy. This study will evaluate the use of 5-aza for maintenance after HCT in patients with AML or MDS with risk factors that are associated with a high risk for relapse.
Phase II study of 5-aza maintenance after allogeneic Hematopoietic Cell Transplantation (HCT)
for high-risk Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS). Early studies
indicate 5-aza is a hypomethylating agent that has shown immune modulating properties that
may enhance the graft-versus-leukemia (GVL) effect, including upregulation of
tumor-associated antigen and costimulatory molecule expression. 5-aza also has properties
that suggest protection against graft-versus-host disease (GVHD). The primary objective is to
evaluate relapse rate at one year. Secondary objectives will include the incidence of both
acute and chronic GVHD as well as relapse-free survival, overall survival and toxicity.
Correlatives will be performed to evaluate the effect of 5-aza maintenance on the immune
system.
Subjects must be transplant candidates with MDS or high risk characteristics of AML. Subjects
are consented, screened, then transplanted. Those showing complete response and no active
GVHD after transplant can proceed to maintenance with 5-aza. Bone marrow biopsies are
performed for response assessment after transplant as well as every three cycles (1 cycle=28
days) while on treatment. Dosing starts at 32mg/m2 and can be increased every 2 cycles
without a serious adverse event (SAE), or reduced per toxicity for up to 12 cycles.
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