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ODYSSEYNCT06517875

Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 8 versions: 8 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 39 words Show 4 more changesShow less
    • Study completion pushed from Mar 17, 2028 to Jan 31, 2029
    • Primary completion date: Mar 19, 2027 to Mar 16, 2027
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised at 11 of 33 sites
  2. Eligibility criteria expanded, about 56 wordsv7 Show 4 more changesShow less
    • Enrollment target: 56 to 68
    • Study sites: 14 to 33
    • Primary completion date: Oct 14, 2026 to Mar 19, 2027
    • Study completion date: Nov 13, 2026 to Mar 17, 2028
  3. Study sites: 12 to 14v6
  4. Study sites: 7 to 12v5
  5. Study sites: 1 to 7v4
Show 2 earlier versionsHide 2 earlier versions
  1. Phase: Phase 1/2 to Phase 2v3
  2. Phase: Phase 2 to Phase 1/2v2 Show 5 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary completion date: Aug 14, 2026 to Oct 14, 2026
    • Study completion date: Aug 25, 2026 to Nov 13, 2026
    • Start date changed from estimate of Dec 17, 2024 to Feb 28, 2025
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Percentage of Participants with TI Response by Week 24
Timeframe: Up to Week 24

Secondary (5)

Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Number of Participants with Clinically Important Changes in Laboratory Parameters, Vital Signs, and Eastern Cooperative Oncology Group (ECOG) Performance Status
Percentage of Participants with TI at the End of Week 24
Plasma Concentration of MMB
Plasma Concentration of Morpholino Lactam (M21)

Arms and interventions

Momelotinib + LuspaterceptExperimental

Participants with transfusion dependent primary myelofibrosis or post- PV/ ET myelofibrosis that is JAKi naïve or JAKi experienced will receive momelotinib and luspatercept.

Drugs: Momelotinib, Luspatercept

Sites

33 sites in 6 countries

France 7, Spain 7, Italy 6, United States 5, Canada 4, Germany 4