Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Allogeneic hematopoietic stem cell transplantation (HSCT) is increasingly used as an effective treatment for malignant disease. The three most common sources for stem cells used in HSCT are bone marrow (BM), umbilical cord blood (UCB), and peripheral blood stem cells (PBSC). In a retrospective review of 1,525 adults with acute leukemia receiving allogeneic transplants between 2002 and 2006, UCB accounted for 10.8%, PBSC for 58.2%, and BM for 31% of the population (Eapen et al., 2010). PBSC as a source of hematopoietic stem cells for transplantation has advantages over bone marrow in terms of donation ease and comfort and over cord blood in terms of adequate cell dose. However, PBSC transplantations are associated with an increased incidence of graft-versus-host disease (GVHD). Based on current literature acute GVHD (aGVHD) is reported in 48-80% of PBSCT recipients (Eapen et al., 2010, Ferrara et al., 2009). Additionally, the myeloablative conditioning regimens used for these transplants often result in mucositis which can be debilitating to patients. TXA127 is pharmaceutically-formulated angiotensin 1-7, a non-hypertensive derivative of angiotensin II. 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 the incidence of aGVHD and mucositis in this patient population. ;


Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT01882387
Study type Interventional
Source Tarix Pharmaceuticals
Contact
Status Withdrawn
Phase Phase 2
Start date December 2013
Completion date December 2013

See also
  Status Clinical Trial Phase
Recruiting NCT05433090 - An Inpatient Advance Care Planning Intervention for Older Patients With Hematologic Malignancies N/A
Completed NCT00061620 - Phase I Study of Continuous Infusion Schedule of FMdC in Hematologic Malignancies Phase 1
Enrolling by invitation NCT02473757 - Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies
Not yet recruiting NCT06296368 - DISCOVERY: Evaluating a Decision Support Tool for Adults Seen in Hematology/Oncology Clinics N/A
Recruiting NCT02032446 - Umbilical Cord Derived Mesenchymal Stromal Cells For The Treatment of Severe Steroid-resistant Graft Versus Host Disease Phase 1/Phase 2
Recruiting NCT01203722 - Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies Phase 1/Phase 2
Recruiting NCT02884375 - Elderly CAncer Patient N/A
Completed NCT00780052 - Infusional C-myb ASODN in Advanced Hematologic Malignancies Phase 1
Recruiting NCT04098393 - Giving Chemotherapy for a Shortened Amount of Time Before a Stem Cell Transplantation Phase 1
Recruiting NCT06028828 - Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation Phase 2
Completed NCT04538599 - RD13-01 for Patients With r/r CD7+ T/NK Cell Hematologic Malignancies Phase 1
Completed NCT03609827 - Study of Melphalan Drug Exposure in Pediatric Hematopoietic Stem Cell Transplant Patients
Completed NCT01380756 - Study Evaluating Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia Phase 1
Recruiting NCT05849207 - Post-Transplant Cyclophosphamide in Patients Aged >/= 70 Years Undergoing Haploidentical Transplant Phase 1
Not yet recruiting NCT05028478 - A Study of CN202 in Adult Subjects With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies Phase 1/Phase 2
Active, not recruiting NCT02494258 - A Study to Evaluate Long-term Safety of CC-486 (Oral Azacitidine) in Subjects With Hematological Disorders Phase 2
Completed NCT03212560 - Exercise Capacity and Physical Activity Levels in Newly Diagnosed Hematologic Malignant Patients
Active, not recruiting NCT02600208 - Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies With Alpha Beta TCell and B Cell Depletion Using the CliniMACS Device Phase 2/Phase 3
Completed NCT02145403 - Phase 1/2 Study of Carfilzomib for the Prevention of Relapse and GVHD in Allo-HCT for Hematologic Malignancies Phase 1/Phase 2
Completed NCT01949545 - Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Advanced Malignancies and Hepatic Impairment Phase 1