Status:
COMPLETED
Fludarabine and Busulfan Followed by Donor Peripheral Stem Cell Transplant and Antithymocyte Globulin, Tacrolimus, and Methotrexate in Treating Patients With Myeloid Cancer
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral stem cell transplant helps stop the growth of abnormal and cancer cells. It also stops the pati...
Detailed Description
OBJECTIVES: Primary * Determine the incidence and severity of acute graft-versus-host disease (GVHD) in patients with myeloid malignancies treated with conditioning regimen comprising fludarabine ph...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following myeloid malignancies:
- Chronic myelogenous leukemia meeting 1 of the following criteria:
- Chronic phase
- Accelerated phase
- Treated blast phase
- Acute myeloid leukemia meeting 1 of the following criteria:
- In remission
- In early relapse, defined as \< 10% marrow blasts
- Myelodysplastic syndromes, including all risk groups
- Other myeloproliferative disorders
- HLA-A, -B, -C, -DRB1, and -DQB1 matched related or unrelated donor available
- PATIENT CHARACTERISTICS:
- No other disease that would severely limit life expectancy
- AST ≤ 2 times normal
- Creatinine ≤ 2 times normal OR creatinine clearance ≥ 60 mL/min
- No cardiac insufficiency requiring treatment
- No symptomatic coronary artery disease
- PO\_2 ≥ 70 mm Hg AND DLCO ≥ 70% of predicted OR PO \_2 ≥ 80 mm Hg AND DLCO ≥ 60% of predicted
- HIV negative
- Not pregnant or nursing
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- No post-transplantation growth factor during methotrexate administration
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00346359
Start Date
March 1 2006
End Date
November 1 2007
Last Update
May 14 2010
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024