Status:
COMPLETED
Tacrolimus and Mycophenolate Mofetil in Preventing Acute Graft-Versus-Host Disease in Patients With Advanced Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation
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: Tacrolimus and mycophenolate mofetil may be an effective treatment for graft-versus-host disease caused by donor stem cell transplantation. PURPOSE: This phase II trial is studying how wel...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy of tacrolimus and mycophenolate mofetil in preventing acute graft-vs-host disease in patients with advanced hematologic malignancies undergoing allogenei...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following hematologic malignancies:
- Acute myeloid leukemia beyond first complete remission (CR1)
- Acute lymphoblastic leukemia beyond CR1
- Chronic myelogenous leukemia in second chronic phase, accelerated phase, or blastic phase
- Non-Hodgkin's lymphoma beyond CR2
- Hodgkin's lymphoma beyond CR2
- Multiple myeloma (any stage)
- Myelodysplastic syndromes beyond refractory anemia (including chronic myelomonocytic leukemia)
- Any refractory hematologic malignancy
- Advanced disease
- Scheduled for transplantation of mobilized allogeneic peripheral blood stem cells
- Genotypically HLA-identical stem cell donor available
- PATIENT CHARACTERISTICS:
- Age
- 65 and under
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT and SGPT ≤ 2.0 times ULN
- Renal
- Creatinine clearance ≥ 60 mL/min
- Pulmonary
- No acute pulmonary infection by chest x-ray
- No severe hypoxemia (partial O\_2 \< 70% of predicted) AND DLCO \< 70% of predicted
- No mild hypoxemia (partial O\_2 \< 80% of predicted) AND DLCO \< 60% of predicted
- Other
- Not pregnant or nursing
- Negative pregnancy test
- No active systemic infection not controlled with antimicrobial therapy
- HIV negative (HIV-1 or other virus)
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent T-cell depleted hematopoietic stem cell graft
- Chemotherapy
- Not specified
- Endocrine therapy
- Not specified
- Radiotherapy
- Not specified
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00096096
Start Date
August 1 2004
Last Update
May 13 2010
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024