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

Clinical Trial Details

This study is a global, double-blinded, randomized, phase 3 study. Blinded means the subject will not know which of the two treatments they are getting. Double-blinded means the site study team does not know either. Subjects will have an equal chance of being assigned to the first treatment arm or the second treatment arm. A phase 3 study means the two treatments are being compared to see if adding CPI-0610 works better when combined with Ruxolitinib or does Ruxolitinib work better by itself. To be a part of this study, the subject must not have taken Ruxolitinib before.

Key Eligibility: 

Inclusion criteria:

  • Have confirmed diagnosis of Myelofibrosis
  • Require therapy for Myelofibrosis in the opinion of the Investigator and are eligible for treatment with ruxolitinib

 

Exclusion Criteria:

  • Had splenic irradiation within 6 months of starting study drug
  • Are a candidate for, and willing to undergo allogeneic HSCT, and, in the opinion of the investigator, the benefit of proceeding to an allogeneic HSCT prior to treatment with a JAK2 inhibitor outweighs its risks

 

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Tania J. Curcio, NP, FNP-BC
(212) 746-2571
tjc9003@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2009022671

ClinicalTrials.gov:

NCT04603495

Sponsor:

CPI 0610-04

Status

Open to Enrollment

Age Group

Adult

Sponsor