Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions.

The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period.

Following the Day 169 Response Assessment, subjects who did not show clinical benefit will have the option to unblind. Subjects who were on placebo during the Blinded Core Treatment Period will have the opportunity to crossover into the Open-Label Extension Treatment Period and receive Luspatercept.

Official Title

A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK Inhibitor Therapy and Who Require Red Blood Cell Transfusions

Details

Keywords

Myeloproliferative Disorders, Myelofibrosis, Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Anemia, Luspatercept, ACE-536, Myeloproliferative Neoplasm, JAK2, Red blood cell transfusion, Post-ET MF, Post-PV MF, Reblozyl, Neoplasms, Polycythemia Vera, Polycythemia

Eligibility

Locations

  • Local Institution - 110
    Los Angeles California 90095 United States
  • Local Institution - 119
    Salt Lake City Utah 84112 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT04717414
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 309 study participants
Last Updated