Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
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).
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.
- 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.
- 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.
Publications are currently not available