Study of CPI-0610 in Myelofibrosis (MF)


NCT ID: NCT04603495
Sponsor Protocol Number: 0610-04

About this study

This study aims to determine the efficacy of CPI-0610 + ruxolitinib compared with placebo + ruxolitinibin patients with naive myelofibrosis (MF).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Aged ≥ 18 years.
  • Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia).
  • Adequate hematologic, renal, and hepatic function.
  • Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the MFSAF v4.0.
  • Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system
  • Spleen volume of ≥ 450 cm^3.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Exclusion Criteria:

  • Splenectomy or splenic irradiation in the previous 6 months.
  • Chronic or active conditions and/or concomitant medication use that would prohibit treatment.
  • Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm.

Eligibility last updated 8/25/21. Questions regarding updates should be directed to the study team contact.

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