Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02598297
Phase
PHASE3
Status
Terminated

Conditions

  • Myelofibrosis With High Molecular Risk Mutations

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive disease with increased risk of leukemic transformation and reduced overall survival. As there are no therapies currently established in the subset of high molecular risk patients with early myelofibrosis, the study aimed to evaluate ruxolitinib in this patient population.

Key Dates

Start date
Feb 3, 2016
Status verified
Jul 2019
Primary completion
Oct 23, 2017
Completion
Oct 23, 2017

Study Design

Enrollment
49 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ruxolitinib
    Two tablets of ruxolitinib 5 mg were administered orally twice per day.
  • Placebo Comparator: Ruxolitinib Placebo
    Two tablets of 5mg placebo were administered orally twice per day.

Primary Outcome Measure

Progression Free Survival (PFS-1) [ Time Frame: From randomization till disease progression (estimated to be assessed up 48 months) ]

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