TXA127 in Enhancement of Engraftment in Adult Double Cord Blood Transplantation (USBTXA127CBT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01300611|
Recruitment Status : Active, not recruiting
First Posted : February 21, 2011
Last Update Posted : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Double Cord Blood Transplant Acute Myelogenous Leukemia Myelodysplastic Syndrome Myelofibrosis Acute Lymphoblastic Leukemia Chronic Myelocytic Leukemia Non Hodgkins Lymphoma Hodgkins Lymphoma Chronic Lymphocytic Leukemia||Drug: TXA127 300 mcg/kg/day Drug: TXA127 1000 mcg/kg/day||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase I Evaluation of the Safety and Efficacy of TXA127 (Angiotensin 1-7) to Enhance Engraftment in Adults Undergoing Double Cord Blood Transplantation|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: TXA127 300 mcg/kg/day
Treatment group 1 (300 mcg/kg/day) of a two-arm, dose-escalation pilot feasibility trial of TXA127 (Angiotensin 1-7) in subjects undergoing double cord blood transplantation for the treatment of a variety of hematologic malignancies for whom there is no available therapy with substantive anti-disease effect.
Drug: TXA127 300 mcg/kg/day
Injection, 300 mcg/kg/day for 28 days
Experimental: TXA127 1000 mcg/kg/day
Treatment group 2 (1000 mcg/kg/day) of a two-arm, dose-escalation pilot feasibility trial of TXA127 (Angiotensin 1-7) in subjects undergoing double cord blood transplantation for the treatment of a variety of hematologic malignancies for whom there is no available therapy with substantive anti-disease effect.
Drug: TXA127 1000 mcg/kg/day
Injection, 1000 mcg/kg/day for 28 days
- Safety of TXA127 (Angiotensin 1-7) in subjects undergoing double cord blood transplantation [ Time Frame: 100 days post-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.
- Platelet transfusion requirements [ Time Frame: 100 days post-transplantation ]Platelet transfusion requirements based on units of platelets transfused and days of platelet transfusions
- Immune reconstitution [ Time Frame: 100 days post-transplantation ]Immune reconstitution will be assessed via the measurement of peripheral blood concentrations of CD3+, CD4+, CD8+, CD19+, and CD56+ cells (performed at Study Days 62 and 100).
- Incidence, duration, and severity grade of mucositis [ Time Frame: 100 days post-transplantation ]Incidence of mucositis is defined by the occurrence of least one adverse event with MedDRA preferred term that includes "mucositis" or "stomatitis". The severity grade will be determined by NCI-CTCAE.
- Incidence, duration, and severity grade of acute graft-vs-host-disease (aGVHD) [ Time Frame: 100 days post-transplantation ]Incidence, severity and duration of aGVHD will be reported as a proportion (with 95% CIs) of subjects with Grade II-IV aGVHD. All incidents of aGVHD will at a minimum be listed, with the severity and time course included.
- Time to engraftment/recovery [ Time Frame: 100 days post-transplantation ]Time to neutrophil engraftment and platelet recovery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01300611
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Uday R Popat, MD||M.D. Anderson Cancer Center|