drugset / Trial / NCT01862965
Treatment of Newly Diagnosed Moderate or Severe Chronic Graft-versus-host Disease With Prednisone and Everolimus
Phase 2
Completed
38 enrolled
University Medical Center Hamburg-Eppendorf
Crolll Gmbh · collabNovartis · collab
NaSingle-groupOpen-labelTreatment
Summary
In this study patients with moderate to severe chronic graft-versus-host disease will be treated with a combination of prednisone and everolimus. Patients will be treated on the study for a maximum of 12 months and followed up for another 12 months. The primary hypothesis of this study is that the addition of everolimus to prednisone increases response rates without increasing treatment related mortality or mortality due to relapse of underlying disease.
Timeline
- Start
- 2013-03-06
- Primary completion
- 2018-02-07
- Completion
- 2019-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Everolimus | Small molecule | 0.25 mg | Oral |
| Subject | Everolimus | Small molecule | 0.75 mg | Oral |
| Subject | Prednisone | Other / unclassified | 1 mg/kg | Oral |