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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with fludarabine, thiotepa, and antithymocyte globulin before transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with acute myeloid leukemia in remission.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antilymphocyte Serum; Fludarabine; Fludarabine phosphate; Thiotepa

Criteria

DISEASE CHARACTERISTICS:

• Morphologically confirmed acute myeloid leukemia of 1 of the following subtypes:

• Acute myeloblastic leukemia (M0, M1, M2)

• Acute myelomonocytic leukemia (M4)

• Acute monocytic leukemia (M5)

• Acute erythroleukemia (M6)

• Acute megakaryocytic leukemia (M7)

• Must have 1 of the following karyotypic abnormalities at the time of diagnosis:

• Complex cytogenetic abnormalities (≥ 3 cytogenetic clones)

• Abnormalities of chromosome 5 [-5 or del(5q)]

• Abnormalities of the long (q) arm of chromosome 3, 9, 11, 20, or 21

• Abnormalities of the short (p) arm of chromosome 17, monosomy 7, t(9;22), or t(6;9) (8)

• In morphologic first complete remission*, as evidenced by all of the following for ≥ 4 weeks before study entry:

• Absolute neutrophil count > 1,000/mm^3

• Platelet count > 100,000/mm^3

• Leukemic blasts not present in the peripheral blood

• Cellularity of bone marrow biopsy > 20% with maturation of all cell lines

• Less than 5% blasts by bone marrow biopsy

• No extramedullary leukemia, such as CNS or soft tissue involvement NOTE: *Reduced hemoglobin concentration or hematocrit has no bearing on remission status

• Haploidentical (3/6 or 4/6 antigen matched [A, B, and DR]) family donor available

PATIENT CHARACTERISTICS:

Age

• 18 to 59

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• Bilirubin ≤ 2.0 mg/dL

• AST < 2 times upper limit of normal

Renal

• Creatinine ≤ 1.5 mg/dL

Cardiovascular

• Ejection fraction > 40% by MUGA or echocardiogram

• None of the following within the past 3 months:

• Myocardial infarction

• Significant congestive heart failure

• Significant cardiac arrhythmia

Pulmonary

• FEV_1 and DLCO > 50% of predicted

Immunologic

• HIV negative

• No active or unresolved infection

• No evidence of invasive fungal infection (e.g., positive blood or deep tissue cultures or stains)

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No organ damage

• No other medical problem that would preclude study participation

• No other currently active tumor that would likely interfere with study treatment or that would likely compromise the patient's morbidity or mortality

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent routine use of filgrastim (G-CSF) or sargramostim (GM-CSF) to accelerate hematopoietic recovery post-transplantation

Chemotherapy

• More than 4 weeks since prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• Not specified