Efficacy Study of a TXA127 to Reduce Acute Graft-vs-Host Disease in Subjects Undergoing Double Umbilical Cord Blood Transplantation

• Status: Withdrawn
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy of TXA127 to reduce the incidence (Grade II-IV) of acute Graft-vs.-Host Disease (aGVHD) in adult subjects undergoing double umbilical cord blood transplantation (UCBT). The study will also evaluate the effects of TXA127 on incidence, severity and duration of mucositis; neutrophil engraftment and platelet recovery; platelet transfusion requirements; immune reconstitution; and duration of corticosteroid use. TXA127 has shown to be well tolerated by patients and appears to induce rapid production of neutrophils and platelets in the bloodstream, as well as increase the immune system components. TXA127 has also been shown reduce the severity of chemotherapy-induced mucositis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tarix Pharmaceuticals
• Treatments: Angiotensin I (1-7)

Criteria

Inclusion Criteria:

• Provided written informed consent.

• ≥18 years of age.

• Meet institutional standard criteria for double UCB 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.

Exclusion Criteria:

• 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.