Phase II Study Evaluating the Safety and Efficacy of TXA127 in the Acceleration of Platelet Recovery Following Autologous Peripheral Blood Stem Cell Transplant in Patients With Hodgkin Lymphoma, Non-Hodgkin Lymphoma or Multiple Myeloma Undergoing Limited Reinfusion of CD34+ Cells
- This is a randomized, double-blind (Investigator and Study Subject), placebo-controlled
study.
- The conditioning regimen and mobilization agents used will be up to the discretion of
the Study Center Investigator
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Platelet recovery
Evaluate the effectiveness of TXA127 in accelerating the time to initial platelet recovery following PBSC transplant with a limited number of CD34+ cells, defined as CD34+ cell concentrations ≥1.5 x 106 and ≤5.0 x 106 CD34+ cells/kg. Platelet recovery is defined as that day the subject achieves a post-nadir platelet count of ≥20 x 109/L with no platelet transfusion in the prior 7 days.
≤ 28 days from re-infusion of CD34+ cells
Yes
Michael Schuster, MD
Principal Investigator
Stony Brook university Medical Center
United States: Food and Drug Administration
TXA127-2009-001
NCT01121120
June 2010
June 2013
Name | Location |
---|---|
Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Emory University | Atlanta, Georgia 30322 |
Washington University | St. Louis, Missouri 63110 |
IU Simon Cancer Center | Indianapolis, Indiana 46202 |
University of Virginia Health System | Charlottesville, Virginia 22903 |
City of Hope Hospital | Duarte, California 91010 |
Montefiori Medical Center | Bronx, New York 10467 |
Stony Brook | Long Island, New York |