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MODULAATE: AAT for the Prevention of aGVHD in Patients Receiving HCT
NCT03805789Phase 3
Key facts
- Status
- Terminated
- Start
- Mar 2019
- Primary completion
- Mar 2026
- Countries
- 8
- Sponsor
- CSL Limited
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- Acute Graft-Versus-Host Disease (aGvHD)
01
Overview
Phase 3, randomised, double-blind trial of alpha-1-proteinase inhibitor in Acute Graft-Versus-Host Disease (aGvHD) (5 arms), sponsored by CSL Limited. Primary endpoint: Time to Grade II-IV acute Graft-versus-host Disease or death at 180 days. Started Mar 2019; status: terminated.
02
Design
5 arms- Study design
- RandomizedDouble-blind
AAT (low dose)
Open label. AAT is a lyophilized product for intravenous (IV) administration
AAT (medium dose)
Open label. AAT is a lyophilized product for IV administration
AAT (high dose)
Open label. AAT is a lyophilized product for IV administration
AAT (selected dose from open-label)
Double-blind. AAT is a lyophilized product for IV administration
Placebo
Albumin solution administered intravenously
03
Who it enrols
Patients >=12 years undergoing myeloablative HCT for hematological malignancies with a related or unrelated donor, excluding those with prior HCT, T cell depleted transplant, or planned use of post-HCT cyclophosphamide.
04
Endpoints
Primary
Time to Grade II-IV acute Graft-versus-host Disease or death
Secondary
Proportion of participants with lower gastrointestinal acute GVHD or Grade III-IV acute GVHD in any organ
Proportion of participants with severe infections defined by NCI-CTCAE >= Grade 3
Proportion of participants with Grade II-IV acute GVHD or death
Proportion of participants with lower gastrointestinal acute GVHD
Number of deaths (relapse and nonrelapse-related)
Proportion of participants with Grade III-IV acute GVHD or death
Proportion of participants with moderate to severe chronic GVHD
Proportion of participants who have discontinued immune suppression therapies
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