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

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00101140

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Adult Acute Erythroid Leukemia Adult Acute Monoblastic and Acute Monocytic Leukemia Adult Acute Myeloid Leukemia	Drug: anti-thymocyte globulin Drug: fludarabine phosphate Drug: thiotepa Procedure: biological therapy Procedure: bone marrow ablation with stem cell support Procedure: chemotherapy Procedure: non-specific immune-modulator therapy Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy	Phase 2

Detailed Description

OBJECTIVES:

Primary

Determine the safety and antileukemia activity of haploidentical allogeneic peripheral blood stem cell transplantation in patients with high-risk acute myeloid leukemia in first remission.

Secondary

Determine the early treatment-related mortality (before day 100) of patients treated with this regimen.
Determine the incidence of acute graft-versus-host disease in patients treated with this regimen.
Determine the incidence of graft failure in patients treated with this regimen.
Correlate a mismatch in the expression of the natural killer cell inhibitory receptors CD158a and CD158b with engraftment and disease recurrence in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive a preparative regimen comprising total-body irradiation twice on day -8; fludarabine IV over 30 minutes on days -7 to -3; thiotepa IV over 2 hours twice on day -7; and antithymocyte globulin IV over 4-6 hours on days -5 to -2. Patients undergo haploidentical allogeneic peripheral blood stem cell transplantation on day 0.

Patients are followed at day 100, at least monthly for 2 years, and then periodically for 3 years.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 2.2 years.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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