Clinical trial NCT00089037 (phase 1/phase 2, status: completed)
Conditions: chronic myeloproliferative disorders, graft versus host disease, leukemia, lymphoma, multiple myeloma and plasma cell neoplasm, myelodysplastic syndromes, myelodysplastic/myeloproliferative diseases
ICD codes: D47.1, D89.810, D89.811, D89.813, D89.812, C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, C96.20, C96.29, D47.09, D46.9, D46.C, D46.Z
Drugs: methotrexate, sirolimus, tacrolimus
SMILES: CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O, CC(=O)CC(C1=CC=CC=C1)C1=C(O)C2=C(OC1=O)C=CC=C2, COC1=CC2=C(C(OC)=C1OC)C1=CC=C(OC)C(=O)C=C1C(CC2)NC(C)=O
Eligibility 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