drugset / Trial / NCT00529035
Ultra-Low Dose Interleukin-2 for Refractory Chronic Graft Versus Host Disease
Phase 1
Completed
29 enrolled
Dana-Farber Cancer Institute
Brigham and Women's Hospital · collabNovartis · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this research study is to determine the safety of IL-2 and the highest dose of this drug that can be given safely to people with chronic graft versus host disease (GVHD). Chronic GVHD is a medical condition that may occur after patients receive a bone marrow, stem cell or cord blood transplant. The donor's immune system may recognize their body (the host) as foreign and attempt to "reject" it. Traditional standard therapy to treat chronic GVHD is prednisone (steroids). Treatment options are limited, and it is thought that IL-2 may help to control chronic GVHD.
Timeline
- Start
- 2007-08
- Primary completion
- 2011-06
- Completion
- 2020-05-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | aldesleukin | Protein / enzyme biologic | 300000 iu | Subcutaneous |
| Subject | aldesleukin | Protein / enzyme biologic | 1e+06 iu | Subcutaneous |
| Subject | aldesleukin | Protein / enzyme biologic | 3e+06 iu | Subcutaneous |