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: | Recruiting |
|---|---|
| Conditions: | Orthopedic, Hematology |
| Therapuetic Areas: | Hematology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 3/31/2019 |
| Start Date: | March 27, 2019 |
| End Date: | February 2023 |
| Contact: | Trial Registration Coordinator |
| Email: | clinicaltrials@cslbehring.com |
| Phone: | 610-878-4000 |
A Phase 2/3, Multicenter, randOmized, Double-blind, Placebo-controlled, stUdy to evaLuate the Safety and Efficacy of Alpha-1 AntiTrypsin for the prEvention of Graft Versus-host Disease in Patients Receiving Hematopoietic Cell Transplant (MODULAATE Study)
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).
placebo‑controlled study for prevention of acute GVHD (aGVHD) in subjects undergoing an
allogeneic hematopoietic cell transplant (HCT).
Inclusion Criteria:
- Male or female subjects, ≥12 years of age, undergoing HCT for hematological
malignancies, including leukemia, lymphoma, multiple myeloma, myelodysplastic syndrome
and myeloproliferative neoplasms
- Planned myeloablative conditioning regimen
Exclusion Criteria:
- Prior autologous or allogeneic HCT
- T-cell depleted transplant or planned use of anti-T cell antibody therapy either ex
vivo or in vivo
- Planned umbilical cord blood (UCB) transplant
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