Constellation Pharmaceuticals is conducting a randomized, double-blind, Phase 3 trial in adult patients with myelofibrosis who have not been previously treated with a JAK inhibitor. The purpose of the study is to evaluate the efficacy and safety of CPI-0610, an oral BET inhibitor, plus ruxolitinib (a JAK inhibitor) compared with ruxolitinib alone.
Trial status: Recruiting, Phase 3
Primary endpoint: SVR35 at 24 weeks
Key secondary endpoint: TSS50 by MFSAF v4.0 at 24 weeks
Other secondary endpoints
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BET=bromodomain and extra-terminal domain; DIPSS=Dynamic International Prognostic Scoring System; OS=overall survival; PFS=progression-free survival; SVR35=spleen volume reduction of ≥35%; TSS=Total Symptom Score; TSS50=Total Symptom Score improvement of ≥50%; MFSAF=Myelofibrosis Symptom Assessment Form.