The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant
Cancer-Related Syndrome
Hematopoietic Malignancies
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes (MDS)
Plasma cell neoplasm
12 Years and older, Male and Female
CSL964_2001 (primary)
NCI-2019-03310
2018-000329-29
Summary
This study is a phase 2 / 3 prospective, double-blind, randomized, multicenter,
placebo-controlled study for prevention of acute GVHD (aGVHD) in participants undergoing
an unrelated (matched or single allele mismatched) or matched related allogeneic
hematopoietic cell transplantation (HCT).
Eligibility
- Male or female participants, >=12 years of age (>= 18 years of age for participants 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.
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.