Phase I Evaluation of the Safety and Efficacy of TXA127 (Angiotensin 1-7) to Enhance Engraftment in Adults Undergoing Double Cord Blood Transplantation
Cord blood as a hematopoietic stem cell source has multiple advantages. Cord blood is
normally discarded at birth and can easily be collected and stored. Availability of numerous
CB banks has resulted in genetically diverse CB units including those from non-Caucasians.
Once a suitable CB unit is located, confirmatory typing can be quickly performed and a donor
unit can be shipped to the transplant center. Furthermore, because a CB graft results in a
lower incidence of graft-versus-host-disease, one or two antigen-mismatched units are
acceptable for transplantation. Despite these advantages, CB has a significant drawback
which is that the number of hematopoietic stem cells obtained from a unit of CB is
significantly lower than from a bone marrow (BM) harvest or peripheral blood stem cell
(PBSC) harvest. Both engraftment and immune reconstitution are delayed in patients
undergoing CB transplant. TXA127 is pharmaceutically-formulated angiotensin 1-7, a
non-hypertensive derivative of angiotensin II (which contains the 8th amino acid conferring
receptor binding to blood pressure receptors). TXA127 has multilineage effects on
hematopoietic progenitors in vitro and in vivo. The hematopoietic properties demonstrated in
preclinical and clinical studies support the investigation of TXA127 to reduce time to
neutrophil and platelet engraftment following transfusion of limited number of CD34+ cells.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Safety of TXA127 (Angiotensin 1-7) in subjects undergoing double cord blood transplantation
The safety and tolerability profile of TXA127 will be provided by descriptively summarizing, at a minimum, the following outcomes: 1) number and proportion of patients with adverse events presented by preferred term, by system organ class (SOC), and by severity grade and relationship to TXA127, as assessed by the Investigator; 2) number and proportion of patients terminating TXA127 due to adverse events related to TXA127; 3) Day 100 treatment-related mortality (TRM) rate; 4) Day 100 mortality rate; 5) number of red blood cell and other blood component transfusions; 6) incidence of infection.
100 days post-transplantation
Yes
Uday R Popat, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Food and Drug Administration
TXA127-2010-001
NCT01300611
January 2011
September 2013
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |