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Sirolimus for Secondary Treatment of Chronic GVHD
NCT00079183Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2002
- Primary completion
- Jul 2009
- Countries
- 1
- Sponsor
- Fred Hutchinson Cancer Center
- Modality
- Small Molecules
- Drugs
- sirolimus
- Conditions
- chronic graft-versus-host disease (cGVHD)
01
Overview
Phase 2, open-label, single-arm trial of sirolimus in chronic graft-versus-host disease (cGVHD), sponsored by Fred Hutchinson Cancer Center. Primary endpoints: Number of Participants Experiencing Treatment Success at 7 years, Number of Participants Experiencing Treatment Failure at 7 years and 2 more. Started Apr 2002; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Sirolimus
Sirolimus added to baseline prednisone + cyclosporine/tacrolimus
03
Endpoints
Primary
Number of Participants Experiencing Treatment Success
Number of Participants Experiencing Treatment Failure
Number of Participants Needing Additional Systemic Therapy
Number of Participants With Recurrent Malignancy
Secondary
Proportion of Patients Who Discontinue Administration of Sirolimus Because of Toxicity
Proportion With Infections Categorized by Organism
Secondary Malignancies
Duration of Treatment With Prednisone
Probability of Survival Without Recurrent Malignancy
Probability of Overall Survival
Probability of Cumulative Incidence of Death Without Recurrent Malignancy
Probability of Cumulative Incidence of Recurrent Malignancy
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