Efficacy Study of a TXA127 to Reduce Graft-vs-Host Disease in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT01882387|
Recruitment Status : Withdrawn (Change in drug product development strategy)
First Posted : June 20, 2013
Last Update Posted : August 31, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Hematologic Malignancies||Drug: TXA127||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Phase II Evaluation of the Efficacy of TXA127 (Angiotensin 1-7) to Reduce Acute Graft-vs.-Host Disease in Adults Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: TXA127, blood draws, physical exams
Single-arm safety/efficacy trial of TXA127 (Angiotensin 1-7) in subjects undergoing allogeneic peripheral blood stem cell transplantation for the treatment of a variety of hematologic malignancies for whom there is no available therapy with substantive anti-disease effect. Treatment dose is 300 mcg/kg/day TXA127.
Injection, 300mcg/kg/day for 28 days
- Incidence of Grade II-IV acute graft-vs-host disease (aGVHD) [ Time Frame: 100 days post-transplantation ]Incidence of Grade II-IV acute graft-vs-host disease (aGVHD) will be assessed using clinical staging and grading criteria as defined in Przepiorka et al. (1995). Duration and severity of aGVHD will also be evaluated.
- 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.
- Neutrophil engraftment and platelet recovery [ Time Frame: 100 days post-transplantation ]Time to initial neutrophil engraftment is defined as the number of days from PBSC transplant to the first of 3 consecutive days of an ANC ≥0.5 × 10^9/L. Time to initial platelet recovery is defined as the number of days from PBSC transplant to the first of 3 consecutive platelet count measurements tested on different days with a count ≥20 × 10^9/L with no platelet transfusion in the prior 7 days.
- Platelet transfusion requirements [ Time Frame: 100 days post-transplantation ]Platelet transfusion requirements are based on cumulative units of platelets transfused and cumulative 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).
- Duration of corticosteroid use [ Time Frame: 100 days post-transplantation ]Duration of corticosteroid use for GVHD will be summarized by frequency (i.e., number of days).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Provided written informed consent.
- ≥18 years of age.
- Meet institutional standard criteria for PBSC transplantation
- Myeloablative conditioning regimen
- Histologically confirmed diagnosis of a hematologic malignancy.
- Life expectancy of >4 months.
- Female subjects capable of reproduction (defined as a subject who has started menses) must agree to the following: 1) Use of an effective oral or IM contraceptive method during the course of the study and 2 months following the last administration of Investigational Product; and 2) must have a negative pregnancy test result within 7 days prior to first Investigational Product dose.
- Uncontrolled infection at the time of transplant.
- Pregnant or breastfeeding.
- Known to be seropositive for HIV or HTLV-1.
- Active CNS disease at the time of study enrollment.
- Treatment with an investigational agent within 30 days of anticipated administration of the first dose of Investigational Product.
- Current alcohol use, illicit drug use or any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit schedule.
- Any co-morbid condition which, in the view of the Principal Investigators, renders the subject at too high a risk from treatment complications and regimen-related morbidity/mortality.
- Prophylactic treatment with palifermin for mucositis.
- Subjects with a known sensitivity to any of the Investigational Product components.
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): NCT01882387
|United States, Georgia|
|Winship Cancer Institute, Emory University|
|Atlanta, Georgia, United States, 30322|
|United States, Missouri|
|Siteman Cancer Center|
|St Louis, Missouri, United States, 63110|
|Principal Investigator:||Edmund K Waller, MD,PhD,FACP||Emory University|
|Responsible Party:||Tarix Pharmaceuticals|
|Other Study ID Numbers:||
|First Posted:||June 20, 2013 Key Record Dates|
|Last Update Posted:||August 31, 2016|
|Last Verified:||August 2016|
Allogeneic Peripheral Blood Stem Cell Transplantation
Graft vs Host Disease
Neoplasms by Site
Immune System Diseases
Angiotensin I (1-7)