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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

Status
Active
Cancer Type
Cancer-Related Syndrome
Hematopoietic Malignancies
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes (MDS)
Plasma cell neoplasm
Trial Phase
Phase II
Phase III
Eligibility
12 Years and older, Male and Female
Study Type
Prevention
NCT ID
NCT03805789
Protocol IDs
CSL964_2001 (primary)
NCI-2019-03310
2018-000329-29
Study Sponsor
CSL Behring

Summary

This study is a Phase 2/3 prospective, double-blind, randomized, multi-center,
placebo-controlled study for prevention of acute GVHD (aGVHD) in subjects undergoing an
allogeneic hematopoietic cell transplant (HCT).

Eligibility

  1. 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
  2. Planned myeloablative conditioning regimen

Treatment Sites in Georgia

Emory University Hospital - Atlanta


1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

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