Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer

DISEASE CHARACTERISTICS:

• Diagnosis of hematological malignancy including any of the following:

  • Non-Hodgkin lymphoma (NHL) in any complete remission (CR) or partial response (PR)
  • Hodgkin lymphoma in any CR or PR

  • Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) in any CR

    • Bone marrow blasts < 20% within 4 weeks of transplant and peripheral blood absolute blast count < 500/µL on the day of initiation of conditioning for patients with non-CR AML or ALL
  • Myelodysplastic syndromes (MDS) treated or untreated
  • Chronic myelogenous leukemia (CML) in chronic or accelerated phase
  • Multiple myeloma in any CR or PR
  • Chronic lymphocytic leukemia in CR or PR 2 or greater

  • Myelofibrosis and other myeloproliferative disorders

    • Bone marrow blasts < 20% within 4 weeks of transplant and peripheral blood absolute blast count < 500/µL on the day of initiation
• High-risk disease defined as AML or ALL > CR1, accelerated phase CML, recurrent aggressive lymphoma, or active lymphoproliferative disease at transplant
• Low-risk disease defined as AML or ALL in CR1, chronic phase CML, or low-grade lymphoproliferative disorder with controlled disease at transplant

• Must be planning to receive 1 of the following conditioning regimens at City of Hope:

  • Fludarabine phosphate and melphalan for patients with hematological malignancies and contraindications for conventional myeloablative regimens due to age, co-morbidity, or previous transplant
  • Fractionated total-body irradiation (FTBI) and etoposide for patients with AML and ALL or CML in accelerated phase
  • FTBI and cyclophosphamide for patients with NHL, AML, CML, and MDS

• Suitable unrelated donor available

  • HLA-matched or mismatched
  • Peripheral blood stem cells available
  • No bone marrow or ex vivo-engineered or processed graft (e.g., CD34-positive, T-cell depletion)
• No uncontrolled CNS disease

PATIENT CHARACTERISTICS:

• Karnofsky performance status (PS) 70-100% or ECOG PS 0-2
• Creatinine < 1.3 mg/dL or creatinine clearance ≥ 70 mL/min
• Ejection fraction > 45%
• Direct bilirubin < 3 times upper limit of normal (ULN)
• ALT and AST < 3 times ULN
• Forced vital capacity, FEV1, and DLCO > 45% of predicted
• Able to cooperate with oral medication intake
• No active donor or recipient serology positive for HIV
• No known contraindication to administration of sirolimus, tacrolimus, or anti-thymocyte globulin
• No active hepatitis B or C
• Negative pregnancy test

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Concurrent participation in other clinical trials for prevention or treatment of viral, bacterial, or fungal disease allowed provided agents do not interact with agents used in the current study