Status:
COMPLETED
Busulfan, Cyclophosphamide, & Antithymocyte Globulin Followed by Stem Cell Transplant in Treating Hematologic Cancer
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Graft Versus Host Disease
Leukemia
Eligibility:
All Genders
19-65 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy before a donor bone marrow transplant or peripheral stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting ...
Detailed Description
OBJECTIVES: Primary * To determine the incidence of grade II-IV acute graft-versus-host disease in patients with hematologic cancer or other diseases treated with a myeloablative conditioning regime...
Eligibility Criteria
Inclusion
- Pathologically confirmed diagnosis of 1 of the following:
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Chronic myelogenous leukemia beyond first chronic phase (i.e., 2nd chronic phase, accelerated phase, or blast crisis)
- Multiple myeloma
- Myelodysplastic syndromes
- Malignant lymphoma
- Myelofibrosis
- Requirement for myeloablative conditioning regimen confirmed by attending physician
- Available donor must meet the following criteria:
- HLA phenotypically identical unrelated donor by low, intermediate, or high resolution for HLA class I antigens, and by high resolution for HLA class II antigens
- Matched at the A, B, and DRβ1 loci
- Single HLA-A or HLA-B antigen mismatch allowed
- Meets all National Marrow Donor Program or foreign registry criteria for allogeneic bone marrow/stem cell donors
- Peripheral blood stem cells are the preferred product on this study but bone marrow is allowed
- Karnofsky performance status 70-100%
- DLCO ≥ 50% predicted
- LVEF ≥ 45%
- Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 65 mL/min
- Serum total bilirubin ≤ 2.0 mg/dL
- Fertile patients must use effective contraception
Exclusion
- No active uncontrolled infection
- Not pregnant or nursing/negative pregnancy test
- No HIV infection
- No chronic active hepatitis B or C or evidence of cirrhosis on liver biopsy
Key Trial Info
Start Date :
June 7 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2008
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00611351
Start Date
June 7 2005
End Date
September 17 2008
Last Update
October 23 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Unversity of Nebraska Medical Center
Omaha, Nebraska, United States, 68198