Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission

Inclusion 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