AAT + Corticosteroids for Graft-versus-Host Disease

Recruiting in Palo Alto (17 mi)

+25 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: CSL Behring

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Study Director

Principal Investigator

CSL Behring

Eligibility Criteria

This trial is for patients aged 12 or older who have acute GVHD after a stem cell transplant and need systemic therapy with corticosteroids. It's not for those previously treated with AAT, having cancer that's returned or not responding to treatment, using steroids within the last week before GVHD onset, or currently on other drugs for GVHD.

Inclusion Criteria

I am 12 years old or older.

I have had a transplant from any donor or undergone any intensity of preparation treatment.

I have acute GVHD after a stem cell transplant.

Exclusion Criteria

My cancer has come back or is getting worse.

I have chronic GVHD or overlap syndrome that started before or at the time of joining.

I started taking systemic corticosteroids within 7 days before my acute GVHD symptoms began.

Treatment Details

Interventions

• Alpha-1 antitrypsin (AAT) (Other)
• Placebo (Other)

Trial Overview The study compares two treatments for acute GVHD: one group receives Alpha-1 antitrypsin (AAT) plus corticosteroids, while the other gets a placebo alongside corticosteroids. The goal is to see if adding AAT improves outcomes.

Participant Groups

Group I: AAT Experimental Treatment 1 Intervention

Alpha-1 antitrypsin (AAT) is a lyophilized powder for intravenous administration

Group II: Placebo Placebo Group 1 Intervention

Albumin solution administered intravenously

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Medical College of Wisconsin Milwaukee, WI

University of Wisconsin Madison, WI

Fred Hutchinson Clinic Seattle, WA

Mount Sinai Medical Center New York, NY

More Trial Locations

Who Is Running the Clinical Trial?

CSL Behring

Lead Sponsor

Trials

204

Patients Recruited

1,207,000+

National Institutes of Health (NIH)

Collaborator

Trials

2896

Patients Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14080

Patients Recruited

41,180,000+

Blood and Marrow Transplant Clinical Trials Network

Collaborator

Trials

51

Patients Recruited

14,600+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3987

Patients Recruited

47,860,000+