{"entity":{"id":"nct04717414","kind":"trial","name":"An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomi","aka":["INDEPENDENCE"],"tldr":"A phase 3 trial of Luspatercept in myeloproliferative neoplasms, run by Celgene, active and no longer recruiting.","summary":"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.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04717414","url":"https://clinicaltrials.gov/study/NCT04717414"}],"tags":["ctgov-ingest"],"related":[],"cancers":["myeloproliferative-neoplasms","primary-myelofibrosis"],"sections":[],"technologies":["transfusion-support"],"targets":[],"drugs":["luspatercept"],"companies":["bms"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04717414","phase":"3","setting":"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","sponsor":"Celgene","started":"2021-02-25","startedType":"actual","yearReported":2026,"enrolled":313,"enrolledBasis":"registry","outcomes":[{"endpoint":"Red Blood Cell-transfusion Independence (RBC-TI) ≥ 12 Weeks (RBC-TI 12)","primary":true,"unit":"%","arms":[{"name":"Treatment","n":208,"value":23.08,"note":"95% CI 17.53 to 29.41; Figures from the ClinicalTrials.gov results section (first posted 2026-07-16), not from a publication"},{"name":"Control","n":105,"value":13.33,"note":"95% CI 7.49 to 21.36"}],"p":"0.0674","source":"https://clinicaltrials.gov/study/NCT04717414?tab=results"}]},"route":"/trials/nct04717414/","neighbours":{"cancer":[{"id":"myeloproliferative-neoplasms","kind":"cancer","name":"Myeloproliferative neoplasms (PV, ET, myelofibrosis)","route":"/cancers/myeloproliferative-neoplasms/"},{"id":"primary-myelofibrosis","kind":"cancer","name":"Primary myelofibrosis","route":"/cancers/primary-myelofibrosis/"}],"technology":[{"id":"transfusion-support","kind":"technology","name":"Transfusion support and anaemia management","route":"/technologies/transfusion-support/"}],"drug":[{"id":"luspatercept","kind":"drug","name":"Luspatercept","route":"/drugs/luspatercept/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"}]}}