Trial intelligence / Profile preview

Luspatercept versus epoetin alfa for transfusion-dependent lower-risk myelodysplastic syndromes

2022-501485-22-00Phase 3Authorised

Sponsor
Celgene Corporation
Start
Dec 2018
Modality
Recombinant Proteins and Enzymes, Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
Countries
25
01

Overview

Phase 3, randomised, open-label trial in myelodysplastic syndrome (MDS) comparing Luspatercept arm with Epoetin alfa arm (2 arms). Primary endpoint: Proportion of subjects who are RBC transfusion-free for any 12-week period associated with a concurrent mean hemoglobin increase >= 1.5 g/dL compared to baseline. Planned start Dec 2018; status: authorised.

02

Drugs

luspaterceptepoetin alfa
03

Conditions

myelodysplastic syndrome (MDS)

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