Efficacy Study of a TXA127 to Reduce Graft-vs-Host Disease in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation

NCT01882387 | Withdrawn Phase 2 DMC

• 1 other identifier: TXA127-2012-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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 allogeneic peripheral blood stem cell transplantation (PBSCT). 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.

Conditions

Hematologic Malignancies

Keywords

Allogeneic Peripheral Blood Stem Cell Transplantation; Graft-vs-Host Disease; Neutrophil Engraftment; Platelet Engraftment; Immune Reconstitution; Mucositis

Outcome Measures

Primary Outcomes (1)

• Incidence of Grade II-IV acute graft-vs-host disease (aGVHD)

  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.

  100 days post-transplantation

Secondary Outcomes (5)

• Incidence, duration, and severity grade of mucositis

  100 days post-transplantation

• Neutrophil engraftment and platelet recovery

  100 days post-transplantation

• Platelet transfusion requirements

  100 days post-transplantation

• Immune reconstitution

  100 days post-transplantation

• Duration of corticosteroid use

  100 days post-transplantation

Study Arms (1)

TXA127, blood draws, physical exams

EXPERIMENTAL

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.

Drug: TXA127

Interventions

TXA127 DRUG

Injection, 300mcg/kg/day for 28 days

TXA127, blood draws, physical exams

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tarix Pharmaceuticals: lead

Study Sites (2)

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Graft vs Host Disease; Mucositis

Interventions

angiotensin I (1-7)

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Edmund K Waller, MD,PhD,FACP

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 20, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

US (2)