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

Must not have

Prior autologous or allogeneic HCT

T-cell depleted transplant or planned use of anti-T cell antibody therapy either ex vivo or in vivo (ie, anti-thymocyte globulin [ATG], alemtuzumab) for GVHD prophylaxis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 180 days after hematopoietic cell transplantation (hct)

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stem cell transplant before.

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I am undergoing or planning to undergo a treatment that targets T-cells for graft-versus-host disease.

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I am scheduled for a stem cell transplant using umbilical cord blood.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 180 days after hematopoietic cell transplantation (hct)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 180 days after hematopoietic cell transplantation (hct)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 180 days after hematopoietic cell transplantation (hct) for reporting.