drugset / Trial / NCT01627314
The PUMA Trial is a Trial of a Single ProHema Modulated-Cord Blood (CB) Unit as Part of a Double CB Transplant in Patients With Hematologic Malignancies.
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is an open-label randomized, prospectively and historically controlled trial of the safety and efficacy of a single ProHema-CB unit used as part of a double CB transplant following myeloablative or reduced intensity conditioning for subjects age 15-65 years with hematologic malignancies. A maximum of 60 eligible subjects will be enrolled and treated in the trial at approximately 10 centers within the U.S.
Timeline
- Start
- 2012-07
- Primary completion
- 2016-03
- Completion
- 2017-05
Outcome
Outcome not reported
Stopped (Business): “Business decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ProHema-CB | Cell therapy | — | — |
| Comparator | Untreated CB | Cell therapy | — | — |