A phase 3 trial of Luspatercept in myeloproliferative neoplasms, run by Celgene, active and no longer recruiting.
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 is a phase 3 interventional study registered as NCT04717414 by Celgene, with 313 participants enrolled, started 2021-02-25 and due to reach its primary completion in 2025-05-26. Interventions recorded: ACE-536, Placebo. Conditions listed: Myeloproliferative Disorders, Myelofibrosis, Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
313 enrolled.
95% CI 17.53 to 29.41; Figures from the ClinicalTrials.gov results section (first posted 2026-07-16), not from a publication · 95% CI 7.49 to 21.36
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Red Blood Cell-transfusion Independence (RBC-TI) ≥ 12 Weeks (RBC-TI 12)primary | Treatment | 208 | 23.08% | - | 0.0674 | link |
| Control | 105 | 13.33% |
Shares Luspatercept, Transfusion support and anaemia management, Myeloproliferative neoplasms (PV, ET, myelofibrosis), Bristol Myers Squibb.
Shares Luspatercept, Transfusion support and anaemia management, Bristol Myers Squibb.
Shares Luspatercept, Transfusion support and anaemia management, Bristol Myers Squibb.
Shares Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis), Bristol Myers Squibb.
Shares Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis).
Shares Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis).
Shares Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis).
Shares Luspatercept, Transfusion support and anaemia management, Primary myelofibrosis.