Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and antithymocyte globulin before and after transplant may stop this from happening.

PURPOSE: This phase II trial is studying the side effects of giving sirolimus together with tacrolimus and antithymocyte globulin and to see how well it works in preventing graft-versus-host disease in patients with hematologic cancer who are undergoing donor stem cell transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antilymphocyte Serum; Busulfan; Carmustine; Cyclophosphamide; Cytarabine; Etoposide; Etoposide phosphate; Fludarabine; Fludarabine phosphate; Melphalan; Rituximab; Sirolimus; Tacrolimus; Thymoglobulin; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of a hematological malignancy, including any of the following:

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

• Hodgkin lymphoma in CR or PR

• Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) meeting either of the following criteria:

• In CR

• Not in CR and meets the following criteria:

• Bone marrow blast < 20% within 4 weeks of transplantation

• Peripheral blood absolute blast count < 500 per microliter on the day of initiating conditioning therapy

• Myelodysplastic syndromes, treated or untreated

• Chronic myeloid leukemia in chronic phase or accelerated phase

• Multiple myeloma in CR or PR

• Chronic lymphocytic leukemia in second or greater CR or PR

• Myelofibrosis or other myeloproliferative disorders meeting the following criteria:

• Bone marrow blasts < 20% within 4 weeks of transplantation

• Peripheral blood absolute blast count < 500 per microliter on the day of initiating conditioning therapy

• Patients with ascites not allowed

• No prior bone marrow or ex vivo engineered or processed graft (i.e., CD34+ enrichment, T-cell depletion, etc)

• Scheduled to undergo peripheral blood stem cell transplantation from a suitable HLA-matched or -mismatched unrelated donor, as determined by treating physician

• High resolution molecular HLA typing is required for HLA class I and II

• No more than one antigen or allele mismatch

• No documented uncontrolled CNS disease

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2

• Karnofsky PS 60-100%

• Creatinine clearance > 50 mL/min

• Bilirubin < 3 times upper limit of normal (ULN)

• ALT and AST < 3 times ULN

• LVEF > 50%

• FVC, FEV_1, or DLCO > 50% predicted

• Patients on home oxygen not allowed

• Able to cooperate with oral medication intake

• HIV negative

• No active hepatitis B or hepatitis C

• No known contraindication to sirolimus, tacrolimus, or anti-thymocyte globulin

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics