← Back to Search

Protein Replacement Therapy

Alpha-1 Antitrypsin for Graft-versus-Host Disease (MODULAATE Trial)

Phase 2 & 3

Recruiting

Research Sponsored by CSL Behring

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned myeloablative conditioning regimen

Male or female subjects, ≥12 years of age (≥ 18 years of age for subjects at German sites only), undergoing HCT for hematological malignancies, including leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome and myeloproliferative neoplasms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through days 60, 100 and 180 after hct

Awards & highlights

MODULAATE Trial Summary

This trial is testing a new drug to see if it can prevent aGVHD in people undergoing an allogeneic HCT.

Who is the study for?

This trial is for males and females aged 12 or older (18+ in Germany) who are undergoing a bone marrow transplant due to blood cancers like leukemia, lymphoma, or myeloma. They must be planning an intense treatment regimen before the transplant. People with previous transplants or those getting certain T-cell treatments can't join.Check my eligibility

What is being tested?

The study tests if Alpha-1 Antitrypsin (AAT), compared to a placebo, can prevent acute Graft-Versus-host Disease after allogeneic hematopoietic cell transplant. It's double-blind meaning neither doctors nor patients know who gets AAT and who gets the placebo.See study design

What are the potential side effects?

Possible side effects of AAT include allergic reactions at the injection site, headaches, dizziness, nausea, and increased risk of bleeding. Since it's being tested for safety too, there may be unknown side effects.

MODULAATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a strong chemotherapy or radiation treatment before a stem cell transplant.

Select...

I am 12 or older (18+ in Germany) and having a transplant for blood cancer.

MODULAATE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through days 60, 100 and 180 after hct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through days 60, 100 and 180 after hct

This trial's timeline: 3 weeks for screening, Varies for treatment, and through days 60, 100 and 180 after hct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The time to Grade II-IV acute graft versus host disease (aGVHD) or death

Secondary outcome measures

Area under the concentration curve (AUC) for AAT

Clearance (CL) of AAT

Ctrough of AAT

+15 more

MODULAATE Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: AAT (selected dose from open-label)Experimental Treatment1 Intervention

Double-blind. AAT is a lyophilized product for intravenous administration

Group II: AAT (medium dose)Experimental Treatment1 Intervention

Open label. AAT is a lyophilized product for intravenous administration

Group III: AAT (low dose)Experimental Treatment1 Intervention

Open label. Alpha-1 antitrypsin (AAT) is a lyophilized product for intravenous administration

Group IV: AAT (high dose)Experimental Treatment1 Intervention

Open label. AAT is a lyophilized product for intravenous administration

Group V: PlaceboPlacebo Group1 Intervention

Albumin solution administered intravenously

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

CSL BehringLead Sponsor

194 Previous Clinical Trials

1,210,756 Total Patients Enrolled

Study PhysicianStudy DirectorCSL Behring

7 Previous Clinical Trials

2,338 Total Patients Enrolled

Media Library

Alpha-1 antitrypsin (AAT) (Protein Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03805789 — Phase 2 & 3

Graft-versus-Host Disease Research Study Groups: AAT (low dose), AAT (medium dose), AAT (high dose), Placebo, AAT (selected dose from open-label)

Graft-versus-Host Disease Clinical Trial 2023: Alpha-1 antitrypsin (AAT) Highlights & Side Effects. Trial Name: NCT03805789 — Phase 2 & 3

Alpha-1 antitrypsin (AAT) (Protein Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03805789 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different medical clinics are participating in this clinical trial?

"The trial has 11 locations in total, with the primary sites being Methodist Hospital in San Antonio, Texas; Scottsdale HH Cancer Transplant in Scottsdale, Arizona; and Emory University in Atlanta, Georgia."

Answered by AI

Are there any more vacancies in this particular clinical trial?

"Yes, this clinical trial is looking for participants and was most recently updated on September 8th, 2022. The original posting date was March 27th, 2019."

Answered by AI

How many total participants are involved in this clinical research?

"Yes, this is an ongoing project that has been recruiting since March 27th, 2019. The most recent update to the trial was on September 8th of this year. They are looking for a total of 310 people to participate at 11 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-Versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant

2019. "The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-Versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03805789.

All > Gvhd