Status:
UNKNOWN
Antithymocyte Globulin and Cyclosporine in Preventing Graft-Versus-Host Disease in Patients Undergoing Chemotherapy With or Without Radiation Therapy Followed By Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Graft Versus Host Disease
Leukemia
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the p...
Detailed Description
OBJECTIVES: Primary * Compare the incidence of acute graft-vs-host disease (GVHD) within the first 100 days after transplantation in patients with acute lymphoblastic leukemia or acute myeloid leuke...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Confirmed diagnosis of acute myeloid leukemia (AML) or acute lymphoblastic leukemia
- In first complete remission or second complete remission
- Secondary AML allowed
- HLA-A, -B, and -DRB1 identical related donor available AND must be fully matched at Class II by high-resolution molecular HLA typing (at least 4 digits)
- Currently receiving a myeloablative conditioning regimen that includes cyclophosphamide
- All patients from a center should receive the same conditioning regimen throughout the study
- No fludarabine or other purine analogues (e.g. cladribine or pentostatin) as part of conditioning regimen
- No uncontrolled CNS disease
- PATIENT CHARACTERISTICS:
- Age
- 18 to 55
- Performance status
- ECOG 0-3
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Bilirubin \< 2 mg/dL
- ALT and/or AST ≤ 3 times normal
- Renal
- Creatinine \< 2.0 mg/dL OR
- Creatinine clearance \> 50 mL/min
- Cardiovascular
- Ejection fraction \> 40%
- No severe cardiac disease
- Other
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known contraindication to administration of rabbit anti-thymocyte globulin
- No current drug or alcohol abuse
- No significant medical or psychosocial problem or unstable disease state (including, but not limited to, morbid obesity) that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior or concurrent bone marrow transplantation from a donor who has positive serology for HIV, hepatitis B virus, hepatitis C virus, or syphilis
- No IV immunoglobulin prior to engraftment
- No concurrent ex vivo engineered or processed graft (CD34+ enrichment or T-cell depletion)
- Chemotherapy
- See Disease Characteristics
- No prior or concurrent methotrexate for graft-vs-host disease prophylaxis
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- More than 30 days since prior experimental agents
- No other concurrent investigational agents
- Enrollment in investigational studies (i.e., anti-microbial agents) allowed only for life threatening events or after exhausting other treatment modalities
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00093587
Start Date
August 1 2004
Last Update
November 6 2013
Active Locations (1)
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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1678