COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial

Conditions

• MPN (Myeloproliferative Neoplasms)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ruxolitinib — DRUG
  Ruxolitinib phosphate tablets 5 mg administered as oral doses.
• Placebo — DRUG
  Matching placebo tablets were administered as oral doses in the same manner as active drug.

Study Details

This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF).

Key Dates

Start date

Aug 31, 2009

Status verified

Feb 2018

Primary completion

Nov 30, 2010

Completion

Oct 31, 2015

Study Design

Enrollment

309 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ruxolitinib
  Participants received ruxolitinib orally twice a day. The starting dose was determined based on Baseline platelet count. Patients with Baseline platelet count \> 200,000/μL began a dose regimen of 20 mg twice daily. Patients with Baseline platelet count of 100,000/μL to 200,000/μL (inclusive) began a dose regimen of 15 mg twice daily. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily. Patients receiving benefit could continue treatment until the later of marketing approval or when the last randomized patient remaining in the study had completed Week 144 (36 months).
• Placebo Comparator: Placebo
  Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting certain protocol requirements detailed below were given the opportunity to cross over to ruxolitinib treatment.

Primary Outcome Measure

Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24 [ Time Frame: Baseline and Week 24 ]

Locations (88)

Related Studies

• MPN PROGRESSion Registry: Observational Study Tracking Symptoms, Treatments, and Disease Progression in People With Myeloproliferative Neoplasms (MPNs)
  Recruiting · MPN Research Foundation · Chicago, Illinois