The Ruxolitinib Versus Best Available Therapy Trial in Patients With High Risk ET in Second Line

Sponsor
French Innovative Leukemia Organisation
Study ID
NCT02962388
Phase
PHASE2/PHASE3
Status
Terminated

Conditions

  • Essential Thrombocythemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Anagrelide — DRUG
    Anagrelide in the study, according to the investigator decision fom day 1 to 48 months
  • Ruxolitinib (JAKAVI®) — DRUG
    Ruxolitinib (JAKAVI®) - Novartis. Tablets 5 mg. Starting dose 10 mg BID, orally. To be increased or decreased (5 or 10 mg steps) per standardized dosing Maximum dose 25 mg BID. fom day 1 to 48 months
  • IFNα/ PegIFNα — DRUG
    IFNα/ PegIFNα in the study, according to the investigator decision fom day 1 to 48 months

Study Details

Prospective national multicenter randomized open label phase IIb RUXBETA trial.

Key Dates

Start date
Jan 3, 2017
Status verified
Jun 2021
Primary completion
Jun 28, 2021
Completion
Jun 28, 2021

Study Design

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

Arms

  • Active Comparator: Reference therapy arm
    Best Available Therapy (BAT) in second line, after hydroxyurea. BAT restricted to anagrelide or IFNα/ PegIFNα in the study, according to the investigator decision
  • Experimental: Investigational therapy arm
    Ruxolitinib JAKAVI® Starting dose 10 mg BID, orally. To be increased or decreased (5 or 10 mg steps) per standardized dosing paradigm. Maximum dose 25 mg BID.

Primary Outcome Measure

Failure-free patients [ Time Frame: month 12 ]

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