An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions
Active, not recruiting · Phase 3 · NCT04717414
Conditions: Myeloproliferative Disorders, Myelofibrosis, Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Anemia
At a glance
- Research payments reported, 2025
- $112,282
- U.S. investigators named
- 7
- Sites paid
- 7
- Planned or actual enrollment
- 313
About the trial
- Sponsor
- Celgene
- Tested
- ACE-536 (drug), Placebo (other)
- Dates
- Started 2021-02-25; completion 2032-08-18
- Results posted
- Yes
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.…
From ClinicalTrials.gov, last updated 2026-07-16. Full record, eligibility and contacts (opens in a new tab)
Industry funding
E.r. Squibb & Sons, L.l.c. reported $112,282 in research payments for this study in 2025 (7 payments).
Products named: Reblozyl
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Gary J. Schiller, MD Hematology & Oncology · Los Angeles, CA
- James K. Mccloskey II, M.D. Medical Oncology · Hackensack, NJ
- Marina Kremyanskaya, M.D. Medical Oncology · New York, NY
- Salman Fazal, M.D. Hematology & Oncology · Harrisburg, PA
- James Rossetti Hematology & Oncology · Pittsburgh, PA
- Prithviraj Bose, MD Hematology & Oncology · Houston, TX
- Srinivas K. Tantravahi, MD Hematology · Salt Lake City, UT
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- University of Pittsburgh Cancer Institute Cancer Services $38,305
- Mount Sinai School of Medicine $29,160
- Hackensack University Medical Center, NJ $15,114
- Ut MD Anderson Cancer Center $9,863
- Ronald Reagan UCLA Medical Center, CA $7,375
- University of Utah Hospital and Clinics, UT $6,729
- Allegheny-Singer Research Institute (asri) $5,736
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.