Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
HLA-mismatched Allogeneic Cellular Therapy (HMMACT) After Chemotherapy in High Risk Acute Myeloid Leukemia
This phase I trial studies the side effects of donor stem cell transplant in treating patients with high risk acute myeloid leukemia. Giving low doses of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect)
PRIMARY OBJECTIVES:
I. To assess the feasibility of cytarabine based chemotherapy and human leukocyte antigen
(HLA)-mismatched allogeneic cellular therapy (HMMACT) in patients with high risk acute
myeloid leukemia (AML), with feasibility measured by induction mortality (IM) and complete
response rate.
SECONDARY OBJECTIVES:
I. To obtain preliminary estimates of clinical outcome following cytarabine based
chemotherapy and HMMACT in patients with high risk AML, as measured by event free survival
(EFS) and overall survival (OS).
II. To further evaluate the safety outcomes of induction and consolidation of cytarabine and
HMMACT in terms of serious infections (grade 4), time to recovery of absolute neutrophil
counts and platelets and incidence of graft versus host disease (GvHD).
III. To further evaluate the feasibility of this approach in terms of identifying a suitable
donor in this elderly population.
IV. To compare in preliminary manner the clinical outcomes of cytarabine and HMMACT in
patients with high risk AML as measured by complete response rate (CRR), event free survival
(EFS) and overall survival (OS) by donor/recipient HLA-C1 vs C2 pairs.
V. To characterize in a preliminary manner, the numbers of suppressor regulatory T cells
(Tregs), T helper 17 cells (Th17), and cytotoxic T cells during pre and post HMMACT
treatment, and with clinical outcomes in leukemia.
OUTLINE:
INDUCTION CHEMOTHERAPY: Patients receive mitoxantrone hydrochloride intravenously (IV) on
days 1-3 and cytarabine IV on days 1-7.
HMMACT: Patients receive filgrastim (G-CSF) mobilized peripheral blood stem cells (G-PBSC) on
day 9. After completion of study treatment, patients are followed up monthly for 3 years.
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