Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone (BMT CTN 1705)

Trial ID or NCT#

NCT04167514

Status

not recruiting iconNOT RECRUITING

Purpose

Study CSL964_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD

Official Title

A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Trial of Alpha 1 - Antitrypsin (AAT) Combined With Corticosteroids vs Corticosteroids Alone for the Treatment of High Risk Acute Graft-versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplant (BMT CTN 1705)

Eligibility Criteria

Ages Eligible for Study: Older than 12 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Patients 12 years of age or older - Initial presentation of acute GVHD after allogeneic hematopoietic cell transplantation for any indication - Any graft or donor source or conditioning intensity - Clinical diagnosis of acute GVHD requiring systemic therapy with corticosteroids
Exclusion Criteria:
  1. - Prior exogenous AAT exposure for GVHD prophylaxis - Relapsed, progressing, or persistent malignancy - de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment - Receiving other drugs for the treatment of GVHD - Receiving systemic CS for any indication within 7 days before the onset of acute GVHD
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Investigator(s)

Parveen Shiraz, MD
Parveen Shiraz, MD
Blood and marrow transplant specialist, Hematologist-Oncologist
Instructor, Medicine - Blood & Marrow Transplantation

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Contact

Kimberly Truong Xie
(650) 725-9363

View on ClinicalTrials.gov