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Sirolimus and Tacrolimus for GVHD Prophylaxis After Unrelated Donor Stem Cell Transplant
NCT00144677Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2003
- Primary completion
- Jun 2006
- Countries
- 1
- Sponsor
- Dana-Farber Cancer Institute
- Modality
- Small Molecules
- Drugs
- sirolimus
- Conditions
- graft-versus-host disease (GVHD)
01
Overview
Phase 2, open-label, single-arm trial of sirolimus in graft-versus-host disease (GVHD), sponsored by Dana-Farber Cancer Institute. Primary endpoint: Feasibility of using sirolimus and tacrolimus without methotrexate. Started Nov 2003; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Sirolimus + Tacrolimus
Sirolimus and Tacrolimus combination for GVHD prophylaxis
03
Who it enrols
Adult patients (18-55) with hematologic malignancies (AML, ALL, CML, MDS, Lymphoma) undergoing matched unrelated donor stem cell transplantation, with adequate organ function and no uncontrolled infections.
04
Endpoints
Primary
Feasibility of using sirolimus and tacrolimus without methotrexate
Secondary
Rate of grade II-IV and III-IV acute GVHD
Incidence of 100 day mortality
Overall Survival
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