Pilot Study of Sirolimus, Tacrolimus and Short Course Methotrexate for Prevention of Acute Graft Versus Host Disease in Recipients of Mismatched Unrelated Donor Allogeneic Stem Cell Transplantation

Yale University1 site in 1 country26 target enrollmentOctober 2007

ConditionsStem Cell Transplantation

Interventionstacrolimus Sirolimus Methotrexate

Drugstacrolimus Sirolimus Methotrexate

Overview

Phase: Early Phase 1
Intervention: tacrolimus
Conditions: Stem Cell Transplantation
Sponsor: Yale University
Enrollment: 26
Locations: 1
Primary Endpoint: Safety/Efficacy of a novel regimen of sirolimus, tacrolimus and methotrexate
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this trial is to study the safety and efficacy of a novel regimen of sirolimus, tacrolimus and methotrexate as prophylaxis against acute graft versus host disease (GVHD) in recipients of mismatched unrelated donor stem cell grafts. Methotrexate is administered in a low dose format of 5mg/m2 on days +1,3 and 6 only.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

October 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Yale University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must have an identified 8/10 or 9/10 matched unrelated donor identified following a formal search with confirmatory typing through the national marrow donor program as the best available donor. No matched sibling or fully matched unrelated donor has been identified. HLA typing of donor and recipient will be performed by high resolution molecular typing at HLA A, B, C and DRB1/DQ loci. Patients whose best available donor is matched at 8/10 loci must have at least one of the mismatches at the DQ locus. (no more than one mismatch at HLA A,B,C,DR allowed).
•Candidates for this trial will meet the following criteria:
•Adequate organ function for conditioning type:
•For patients receiving ablative conditioning
•Left Ventricular ejection fraction \>45%
•DLCO \>50%
•Creatinine \<1.5
•Hepatic enzymes \<3x upper limit of normal.
•KPS \>70%
•For patients receiving non-ablative conditioning:

Exclusion Criteria

•Prior allogeneic transplantation
•Active CNS leukemia.
•Female patients who are pregnant or breast feeding
•Karnofsky performance status \<70%.
•Active viral, bacterial or fungal infection.
•Patients seropositive for HIV -1,2; HTLV -1,2 (due to the additional immunodeficiency induced by transplantation and immunosuppressive therapy) Requirement for antifungal prophylaxis with Voriconazole for the first 30 days is prohibited.
•Patients not providing informed consent.