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The safety and efficacy of Alpha-1 Antitrypsin (AAT) for the prevention of graft‑versus-host disease (GVHD) in patients receiving hematopoietic cell transplant.
EU CTIS ID: 2024-511164-92-00
What this study is testing
Primary objective is to evaluate the efficacy of AAT at the selected dose for the prevention of acute GVHD following HCT.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- Planned myeloablative conditioning regimen.
- Participants must have a related or unrelated donor as follows: - Related donor must be a 6 / 6 match for human leukocyte antigen (HLA)-A, -B, at intermediate (or higher) resolution, and -DR beta 1 (DRB1) at high resolution using deoxyribonucleic acid (DNA)-based typing. - Unrelated donor must be 7 / 8 or 8 / 8 match for HLA-A, -B, and -C at intermediate (or higher) resolution, and -DRB1 at high resolution using DNA-based typing.
You likely can't join if
- 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.
- Planned umbilical cord blood transplant.
- Planned use of cyclophosphamide after HCT for GVHD prophylaxis.
- Planned haploidentical donor.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Singapore
- Taiwan
- United States
- Korea, Republic of
- United Kingdom
- Australia
- Japan
- Brazil
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Singapore; Taiwan; United States; Korea, Republic of; United Kingdom and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.