drugset / Trial / NCT01747499
Azacitidine in Patients Undergoing Matched Unrelated Stem Cell Transplantation
Phase 1/2
Terminated
54 enrolled
Washington University School of Medicine
National Cancer Institute (NCI) · collabNational Institutes of Health (NIH) · collabThe Foundation for Barnes-Jewish Hospital · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this phase I/II study is to define the maximum tolerated dose of 5-AzaC and the effect on grade II-IV GvHD when given after matched unrelated donor transplant (MUD).
Timeline
- Start
- 2013-04-15
- Primary completion
- 2018-08-31
- Completion
- 2018-12-24
Outcome
Outcome not reported
Stopped (Enrollment): “Enrolling 8 more patients would be statistically unlikely that the primary endpoint would be reached (reduce day 180 grade II-IV GVHD rates to 20% or less)”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 15 mg/m2 | Intravenous |
| Subject | Azacitidine | Other / unclassified | 30 mg/m2 | Intravenous |
| Subject | Azacitidine | Other / unclassified | 37.5 mg/m2 | Intravenous |
| Subject | Azacitidine | Other / unclassified | 45 mg/m2 | Intravenous |