Sirolimus, Tacrolimus, Thymoglobulin and Rituximab as Graft-versus-Host-Disease Prophylaxis in Patients Undergoing Haploidentical and HLA Partially Matched Donor Hematopoietic Cell Transplantation

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This Phase II clinical trial was designed for patients with hematologic malignancies in need of donor peripheral blood stem cell transplant, and have no HLA matched donor. Therefore It will test the efficacy of combining sirolimus, tacrolimus, antithymocyte globulin, and rituximab in preventing graft versus host disease in transplants from HLA Haploidentical and partially mismatched donors.

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

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antilymphocyte Serum; Everolimus; Rituximab; Sirolimus; Tacrolimus

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of a hematological malignancy, including:

• Non-Hodgkin lymphoma

• Hodgkin lymphoma

• Acute myeloid leukemia or acute lymphoblastic leukemia

• Myelodysplastic syndrome (treated or untreated)

• Chronic myelogenous leukemia

• Multiple myeloma

• Chronic lymphocytic leukemia

• Myelofibrosis and other myeloproliferative disorders

• No suitable related HLA-matched or unrelated HLA-matched (8/8 or 7/8 matched) donor

• Available suitable haploidentical or partial-matched unrelated donor (high-resolution molecular HLA typing is mandatory for HLA Class I and II)

• No more than 4/8 HLA allele or antigen mismatch for a haploidentical-related first-degree family member donor

• Only 6/8 or 5/8 allele or antigen match for an unrelated donor

• Scheduled to undergo peripheral blood stem cell transplantation

• Not receiving bone marrow or ex vivo engineered or processed graft (e.g., CD34+ enrichment, T-cell depletion)

• No documented uncontrolled CNS disease

PATIENT CHARACTERISTICS:

• Karnofsky performance status (PS) 70-100%

• ECOG PS 0-2

• Serum bilirubin < 3 times upper limit of normal (ULN)

• ALT and AST < 3 times ULN

• Creatinine clearance > 60 mL/min

• Ejection fraction > 50%

• Forced vital capacity, FEV_1, or DLCO > 50% predicted

• Negative pregnancy test

• Able to cooperate with oral medication intake

• Patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the past 6 months) are eligible provided they are cleared with a stress echo or nuclear myocardial perfusions stress test and a cardiology consult

• No ascites

• No HIV positivity

• No active hepatitis B or C virus infection

• No known contraindication to the administration of sirolimus, tacrolimus, anti-thymocyte globulin, or rituximab

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Not on home oxygen