Rapamycin for Prevention of Chronic Graft-Versus-Host Disease

Phase 1

Terminated

• Conditions: Graft Versus Host Disease
• Interventions: Drug: Rapamycin; Drug: Tacrolimus

• Registration Number: NCT00623012
• Lead Sponsor: Yale University

Brief Summary

The objective of this study is to evaluate feasibility, toxicity and efficacy of using Rapamycin to prevent chronic graft-versus-host-disease (GVHD) during and after the tacrolimus taper in recipients of allogeneic stem cell transplant.

Our hypothesis is that the T cells that can cause chronic GVHD are suppressed but not eliminated by calcineurin inhibitors. Therefore, when the calcineurin inhibitors are discontinued, the T cells may get activated and result in GVHD. Rapamycin on the other hand will allow anergy formation and thus when discontinued, T cells should not get activated. The schedule is designed to have therapeutic rapamycin levels as the tacrolimus is discontinued. Rapamycin will be continued as a single agent for additional 4 weeks and be tapered off in two weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-13
• Study First Posted: 2008-02-25
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2016-10-06
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-09
• Last Update Submitted: 2016-12-09
• Results First Posted: 2017-02-03
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Age ≥18 years
• Received an allogeneic MSD or MUD PBSCT
• 24 weeks post SCT
• Currently on Tacrolimus for GVHD prophylaxis
• Deemed eligible for tapering off of Tacrolimus by primary BMT physician

Exclusion Criteria

• Relapsed Disease
• Ongoing GVHD
• Patients whose immunosuppression is being stopped early to treat or prevent relapse
• Patients with pure red cell aplasia due to ABO mismatched donor
• Ongoing thrombotic microangiopathy
• Allergy to rapamycin
• Women of childbearing potential must have a negative serum pregnancy test performed prior to the start of treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Tacrolimus	-
1	Rapamycin	-

Primary Outcome Measures

Name	Time	Method
Improvement of the Rate of Graft Versus Host Disease (GVHD) From the Accepted Rate of 74%.	up to 8 weeks	Percentage of patients free from graft versus host disease

Secondary Outcome Measures

Name	Time	Method
Overall Survival	up to 10 weeks	achieved overall survival in regard to leukemia
Disease Free Survival	up to 10 weeks	achieved disease free in regard to leukemia

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States