Overview

Donor Stem Cell Transplant or Bone Marrow Transplant in Treating Patients With Acute Myeloid Leukemia in Remission

Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Giving chemotherapy before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and methotrexate before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well donor stem cell transplant or bone marrow transplant works in treating patients with acute myeloid leukemia in remission.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asan Medical Center
Treatments:
Antilymphocyte Serum
Busulfan
Cyclophosphamide
Cyclosporine
Cyclosporins
Fludarabine
Fludarabine phosphate
Methotrexate
Criteria
DISEASE CHARACTERISTICS:

- Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:

- Achieved complete response (CR1) after induction chemotherapy

- Recurrent AML that went into second CR (CR2) after salvage chemotherapy, except
those who have undergone prior allogeneic HSCT

- No acute promyelocytic leukemia or acute myeloid leukemia with chromosomal changes
t(8;21), inv 16, or t(15;17)

- Must have a donor available meeting one of the following criteria:

- HLA-matched sibling of 65 years or younger

- 6/6 HLA-matched unrelated donor (younger than 55 years) for antigen A, B, and DR

- HLA-mismatched family member (offspring, parents, haploidentical sibling)

PATIENT CHARACTERISTICS:

- Karnofsky performance status 70-100%

- Bilirubin < 2.0 mg/dL

- AST < 3 times the upper limit of normal

- Creatinine < 2.0 mg/dL

- Ejection fraction > 40% on MUGA scan

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics