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 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2021-11-30
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.
Conditions
Interventions
- BIOLOGICAL
-
ProHema-CB
Ex-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood
- BIOLOGICAL
-
Untreated CB
Cord Blood
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Chris Storgard, M.D. · Fate Therapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2016-03-31
- Completion
- 2017-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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