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Clinical Trial 21279

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04603495

Phase: Phase III
Principal Investigator: Kuykendall, Andrew

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or 1-800-679-0775 Learn More
Overview

Study Title

A Phase 3, Randomized, Double-Blind, Active- Control Study of CPI-0610 and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients

Summary

A Phase 3, randomized, blinded study comparing CPI-0610 and ruxolitinib with placebo and ruxolitinib in myelofibrosis (MF) patients that have not been exposed previously to Janus kinase inhibitors (JAKi). CPI-0610 is a small molecule inhibitor of bromodomain and extra-terminal (BET) proteins. Evidence suggests that inhibition of both BET and JAK pathways can result in synergistic reduction of disease and overall improvement in the prognosis of MF.

Objective

Treatments

Therapies

Therapy (NOS)

Medications

Jakafi (Ruxolitinib); Placebo (); Ruxolitinib (); cpi-0610 ()

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

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.