A Phase II, Randomized Study to Evaluate the Safety and Efficacy of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) For the Treatment of aGVHD in Patients Who Receive Allogeneic Hematopoietic Stem Cell Transplantation
Protocol 260 - Subjects will be randomized with equal probability to the treatment arms (2
million cells/kg of Prochymal or 8 million cells/kg of Prochymal) using a stratified block
design. The stratification factor is acute GVHD grade. For the purpose of stratification,
the GVHD grades are II and III-IV. Treatment with investigational agent was administered on
study Days 1 and 4. Patients were followed for safety and efficacy until Day 28 after
initiation of treatment with the investigational agent, or until withdrawal or death,
whichever occurred first.
Protocol 261 - Subjects were evaluated for safety until 2 years from Day 1 of the preceding
Prochymal® Protocol No. 260 until withdrawal or death.
Protocol 260
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Protocol 260 - Response by Day 28, also called Overall Response. Overall response. includes complete response (CR) and partial response (PR)
28 Days
No
Philip McCarthy, MD
Principal Investigator
Roswell Park Cancer Institute
United States: Food and Drug Administration
260-261
NCT00136903
February 2005
July 2008
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Roswell Park Cancer Institute | Buffalo, New York 14263 |
New York Medical College | Valhalla, New York 10595 |
University of Rochester | Rochester, New York 14642 |
The Cancer Center at Hackensack University | Hackensack, New Jersey 07601 |
St. Francis Hospital | Indianapolis, Indiana 46237 |
Kansas City Cancer Centers - BMT | Kansas City, Missouri 64111 |
Mt. Sinai Hospital | New York, New York 10029 |
Medical College of Wisconsin, FEC | Milwaukee, Wisconsin 53226 |