Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02966353
Phase
PHASE2
Status
Completed

Conditions

  • Post-Essential Thrombocythemia Myelofibrosis
  • Post-Polycythemia Vera-Myelofibrosis
  • Primary Myelofibrosis

Eligibility Criteria

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

Interventions

  • ruxolitinib — DRUG
    Ruxolitinib was supplied in 5 mg tablets to be taken orally approximately 12 hours apart (morning and night)

Study Details

This was a study of treatment with ruxolitinib in patients who presented with transfusion dependent or independent anemia. Starting dose was 10 mg BID. This dose was maintained for the first 12 weeks of the study and up-titrated thereafter unless the subject met criteria for dose hold or dose reduction

Key Dates

Start date
Mar 31, 2017
Status verified
Apr 2020
Primary completion
Jul 24, 2018
Completion
Feb 15, 2019

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All Subjects
    10 mg BID (2 tablets of 5mg) was self-administered as starting dose for all patients. This dose was maintained for the first 12 weeks and titrated up thereafter unless they had met criteria for dose hold or dose reduction. Dose was to have been increased or decreased per standardized dosing paradigm and not to have exceeded 25 mg bid.

Primary Outcome Measure

Percentage of Participants With at Least 50% Reduction in Spleen Length From Baseline at Week 24 [ Time Frame: Baseline up to week 24 ]

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