Status:
WITHDRAWN
Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission
Lead Sponsor:
Eastern Cooperative Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adult Acute Erythroid Leukemia
Adult Acute Monoblastic and Acute Monocytic Leukemia
Eligibility:
All Genders
18-59 years
Phase:
PHASE2
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...
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 firs...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00101140
Last Update
October 19 2017
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