The purpose of this study is to determine the safety and effectiveness of TXA127 in accelerating the time it takes for patients to recover their platelet counts following a Autologous Peripheral Blood Stem Cell transplant.
* 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
75
City of Hope Hospital
Duarte, California, United States
Emory University
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
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.
Time frame: ≤ 28 days from re-infusion of CD34+ cells
Safety of TXA127
Evaluate the safety of TXA127 administration following PBSC transplant
Time frame: ≤ 28 days from re-infusion of CD34+ cells
Initial neutrophil recovery
Determine the effectiveness of TXA127 in accelerating the days to initial neutrophil recovery (ANCs \> 0.5 x 10⁹/L)
Time frame: ≤ 28 days from re-infusion of CD34+ cells
Mucositis
Evaluate the incidence of mucositis Grade 3/4
Time frame: ≤ 28 days from re-infusion of CD34+ cells
Febrile neutropenia
Evaluate the effect of TXA127 in reducing the number of days of febrile neutropenia (fever and ANC \<0.5 x 109/L)
Time frame: ≤ 28 days from re-infusion of CD34+ cells
Platelet transfusions
Evaluate the effect of TXA127 in reducing the number of platelet transfusions needed
Time frame: ≤ 28 days from re-infusion of CD34+ cells
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IU Simon Cancer Center
Indianapolis, Indiana, United States
Washington University
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Stony Brook
Long Island City, New York, United States
Montefiori Medical Center
The Bronx, New York, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States