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.

Phase 2

Terminated

• Conditions: Hematologic Malignancies
• Interventions: Biological: ProHema-CB; Biological: Untreated CB

• Registration Number: NCT01627314
• Lead Sponsor: Fate Therapeutics

Brief 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.

Detailed Description

All subjects will receive a myeloablative or reduced intensity conditioning regimen, after which they will receive 2 Human Leukocyte Antigen (HLA)-matched or partially matched umbilical cord blood (UCB) units. A total of 40 subjects will receive one ProHema-CB as part of a double CB transplant and an additional 20 subjects will be enrolled as concurrent controls. The determination of which CB unit will be the ProHema-CB unit will be made based primarily upon the degree of HLA match.

Study Timeline

• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-06-22
• Study First Posted: 2012-06-25
• Study Start: 2012-07
• Primary Completion: 2016-03
• Study Completion: 2017-05
• Status Verified: 2021-11
• Disposition First Submitted: 2021-11-24
• Disposition First Submitted QC: 2021-11-26
• Last Update Submitted: 2021-11-26
• Disposition First Posted: 2021-11-30
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProHema-CB with MAC Preparative Regimen	ProHema-CB	ProHema-CB and Wash-Only CB Unit with myeloablative conditioning regimen (MAC)
Control Arm with RIC Preparative Regimen	Untreated CB	Two Wash-Only CB Units (Untreated CB) with reduced intensity conditioning regimen
ProHema-CB with RIC Preparative Regimen	ProHema-CB	ProHema-CB and Wash-Only CB Unit with reduced intensity conditioning regimen (RIC)
Control Arm with MAC Preparative Regimen	Untreated CB	Two Wash-Only CB Units (Untreated CB) with myeloablative conditioning regimen

Primary Outcome Measures

Name	Time	Method
Rate of early neutrophil engraftment using Myeloablative Conditioning	Neutrophil engraftment < 26 days	To determine the rate of neutrophil engraftment after a single ProHema-CB unit is used as part of a double CB transplant following myeloablative conditioning for subjects with hematologic malignancies.
Rate of early neutrophil engraftment using Reduced Intensity Conditioning	Neutrophil engraftment < 21 days	To determine the rate of neutrophil engraftment after a single ProHema-CB unit is used as part of a double CB transplant following reduced intensity conditioning for subjects with hematologic malignancies.

Trial Locations

Locations (11)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute- Hematopoietic Stem Cell Transplant Program; 🇺🇸 Boston, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States

Oregon Health Sciences; 🇺🇸 Portland, Oregon, United States

City of Hope; 🇺🇸 Duarte, California, United States

Emory University-Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States