Clinical Trials Search
Clinical Trial 18763
Cancer Type: Malignant Hematology
Interventions:Rapamune (Sirolimus); Rapamycin (Sirolimus); Sirolimus; prednisone
Study Type: Treatment
Phase of Study: Phase II
- Joseph Pidala
A Randomized, Phase II, Multicenter, Open Label, Study Evaluating Sirolimus and Prednisone in Patients with Refined Minnesota Standard Risk, Ann Arbor 1/2 Confirmed Acute Graft-Versus-Host Disease
The purpose of this study is to evaluate 2 medicines for acute graft-versus-host disease (GVHD) and see if they work the same to treat acute GVHD or if one has fewer side effects. The 2 medicines are: Prednisone and Sirolimus. Prednisone is the standard treatment for GVHD. Sirolimus is a medicine that has also been used to treat GVHD. These treatments will be tested in patients whose GVHD is likely to respond to treatment (standard risk GVHD). Investigators will identify standard risk patients by their GVHD symptoms as well as blood tests. Investigators also want to know how the medicines affect quality of life (how well participants can perform their normal everyday activities) and if there are any differences between the medicines.
The primary objective is to assess the rate of complete remission (CR)/partial remission (PR) on day 28 post-randomization in patients with standard-risk acute GVHD defined by both clinical and AA1/2 risk status.