Overview

Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation

Status:
Completed
Trial end date:
2006-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (GVHD) in patients following stem cell transplant from an unrelated donor. This trial is designed to test the hypothesis that elimination of methotrexate in the unrelated donor group would lead to less transplant-related toxicity while still preserving the effective control of GVHD.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dana-Farber Cancer Institute
Treatments:
Everolimus
Sirolimus
Tacrolimus
Criteria
Inclusion Criteria:

- Acute myelogenous leukemia(AML) in first or subsequent remission, in untreated first
relapse or any treated relapse.

- Acute lymphoblastic leukemia(ALL) in first or subsequent remission, in untreated first
relapse or any treated relapse.

- Chronic myelogenous leukemia in first or second chronic stable phase or in accelerated
phase.

- Myelodysplastic syndromes or myeloproliferative diseases

- Non-Hodgkin's lymphoma or Hodgkin's disease in second or greater complete remission,
in partial remission, or induction failure.

- Chronic lymphocytic leukemia, Rai stage 2-4, which has progressed after initial
therapy.

- Matched unrelated donor.

- Age 18-55 years at the time of stem cell transplantation

- ECOG performance status 0-2

- Life expectancy of 100 days without stem cell transplantation

- Total bilirubin < 2.0 mg/dl

- AST < 90 IU

- Serum creatinine < 2.0 mg/dl

- Ejection fraction > 40% by echocardiogram or gated nuclear medicine study.

Exclusion Criteria:

- Uncontrolled infection

- Forced vital capacity or DLCO < 50% predicted for age

- Uncontrolled hypertension

- Prior hematopoietic stem cell transplant

- Evidence of HIV infection or active Hepatitis B or C infection

- Cholesterol > 300 mg/dl

- Relapsed aggressive Burkitt's or Burkitt's-like lymphoma