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AAT + Corticosteroids for Graft-versus-Host Disease

Phase 3
Waitlist Available
Research Sponsored by CSL Behring
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any graft or donor source or conditioning intensity
Initial presentation of acute GVHD after allogeneic hematopoietic cell transplantation for any indication
Must not have
Relapsed, progressing, or persistent malignancy
de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post-randomization
Awards & highlights
Pivotal Trial

Summary

This trial will compare the effectiveness of a combination of AAT and corticosteroids to corticosteroids alone as the first treatment for patients at high risk for developing acute GVHD.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects of AAT may include allergic reactions at the injection site, headaches, dizziness, nausea and vomiting. Corticosteroids can cause increased appetite, mood changes, high blood pressure and higher risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a transplant from any donor or undergone any intensity of preparation treatment.
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I have acute GVHD after a stem cell transplant.
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I have acute GVHD and need steroids for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has come back or is getting worse.
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I have chronic GVHD or overlap syndrome that started before or at the time of joining.
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I have received AAT for preventing graft-versus-host disease.
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I am currently taking medication for graft-versus-host disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of participants with complete or partial response to acute Graft-versus-Host Disease (GVHD) treatment
Secondary study objectives
Duration of response (DOR)
Percent of participants with GVHD-free survival
Percent of participants with Grade 2 to 3 systemic infections
+6 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AATExperimental Treatment1 Intervention
Alpha-1 antitrypsin (AAT) is a lyophilized powder for intravenous administration
Group II: PlaceboPlacebo Group1 Intervention
Albumin solution administered intravenously

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,811 Previous Clinical Trials
8,161,102 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,920 Previous Clinical Trials
41,016,798 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
Blood and Marrow Transplant Clinical Trials NetworkNETWORK
50 Previous Clinical Trials
14,418 Total Patients Enrolled

Media Library

Alpha-1 antitrypsin (AAT) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04167514 — Phase 3
Graft-versus-Host Disease Research Study Groups: Placebo, AAT
Graft-versus-Host Disease Clinical Trial 2023: Alpha-1 antitrypsin (AAT) Highlights & Side Effects. Trial Name: NCT04167514 — Phase 3
Alpha-1 antitrypsin (AAT) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04167514 — Phase 3
~23 spots leftby Nov 2025
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