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

  • STATUS
    Recruiting
  • End date
    Nov 13, 2023
  • participants needed
    122
  • sponsor
    CSL Behring
Updated on 4 October 2022

Summary

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

Details
Condition Graft Versus Host Disease (GVHD)
Treatment Placebo, Alpha-1 antitrypsin (AAT)
Clinical Study IdentifierNCT04167514
SponsorCSL Behring
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients 18 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

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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