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.

NCT01627314 ↗

Phase 2 Terminated 62 enrolled Fate Therapeutics
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

EvaluationDrugModalityDoseRoute
Subject ProHema-CB Cell therapy — —
Comparator Untreated CB Cell therapy — —