Sirolimus, Tacrolimus, and Methotrexate in Preventing Acute Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplantation

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Diagnosis of hematological malignancy
• •* No chronic phase chronic myelogenous leukemia, de novo acute leukemia in first remission, or myelodysplastic syndromes with refractory anemia
• •Scheduled for hematopoietic stem cell transplantation from unrelated donors
• •Currently receiving conditioning regimen comprising cyclosporine and total body radiotherapy (1,200 to 1,350 cGy) or busulfan and cyclosporine
• •Donor must be typed to the highest level of resolution
• •* One single non-serologic disparity for A, B, or C alleles allowed provided the disparity is within the third or fourth digit of the allele
• •* No mismatch at DRB1 or DQB1
• •PATIENT CHARACTERISTICS:
• •Age
• •Per primary treatment protocol
• •Performance status
• •Not specified
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Not specified
• •Hepatic
• •SGOT and SGPT ≤ 2.0 times upper limit of normal
• •Bilirubin normal
• •Hepatitis B and C virus negative
• •Renal
• •Creatinine clearance ≥ 70 mL/min
• •Cardiovascular
• •No cardiac insufficiency requiring treatment
• •No coronary artery disease
• •Pulmonary
• •No acute pulmonary infection by chest x-ray
• •No severe hypoxemia with pO\_2 \< 70 mm Hg AND DLCO \< 70% of predicted
• •No mild hypoxemia with pO\_2 \< 80 mm Hg AND DLCO \< 60% of predicted
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •HIV negative
• •No active systemic infection
• •No known hypersensitivity to macrolide antibiotics (e.g., erythromycin, azithromycin, or clarithromycin)
• •No prior intolerance or unresponsiveness to sirolimus
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •See Disease Characteristics
• •No concurrent T-cell depleted transplantations
• •Chemotherapy
• •See Disease Characteristics
• •Endocrine therapy
• •Not specified
• •Radiotherapy
• •See Disease Characteristics
• •Surgery
• •Not specified
• •Other
• •No concurrent grapefruit juice
• •No concurrent voriconazole