A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial)
Condition: Primary Myelofibrosis
MeSH terms: Primary Myelofibrosis
Intervention: Ruxolitinib
Intervention description: Starting dose was based on reason for previous discontinuation of ruxolitinib (i.e. loss of response or AE) and baseline platelet count. For participants who previously discontinued ruxolitinib due to loss of response, the starting dose was determined based on baseline platelet counts as follows: participants with a baseline platelet count of ≥ 200 x 109/L began dosing at 20 mg po bid; participants with a baseline platelet count of 100 x 109/L to <200 x 109/L began dosing at 15 mg po bid. Participants who previously discontinued ruxolitinib due to an AE initiated therapy at a total daily dose 5 mg lower than the total daily dose prior to discontinuation.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Primary Myelofibrosis; Hematologic Diseases; Myeloproliferative Disorders; INC424; Ruxolitinib

Summary:

      The aim of the study is to assess the efficacy and safety of restarting ruxolitinib after
      treatment interruption due to loss of response and/or adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of PMF, PPV MF or PET-MF, irrespective of JAK2 mutational status
             according to the 2008 revised International Standard Criteria

          -  Peripheral blast count < 10%

          -  Requires therapy for MF in the opinion of the investigator

          -  Received prior monotherapy treatment with ruxolitinib for at least 12 consecutive
             weeks and experienced treatment interruption because of lossof response or adverse
             event

          -  Patients adhering to the Screening phase assessments and undergoing a a
             ruxolitinib-free washout period of a minimum of 1 week and a maximum of 8 weeks

          -  ECOG performance status 0, 1, 2, or 3

          -  Adequate bone marrow function

          -  Written informed consent

        Exclusion Criteria:

          -  Patients not initially responding (primary resistance) to ruxolitinib therapy

          -  Patients who underwent a splenectomy or spleen radiation

          -  Patients currently scheduled for bone marrow transplant

          -  Patients who have discontinued ruxolitinib < 14 days prior to screening

          -  Patients who are not able to receive a starting dose of ruxolitinib of at least 15 mg
             total daily dose

          -  Leukemic transformation

          -  Inadequate renal function

          -  Presence of clinically meaningful active bacterial, fungal, parasitic or viral
             infection which requires therapy

          -  Previous history of Progressive Multifocal Leuko-encephalopathy (PML)

          -  Clinically significant cardiac disease or significant concurrent medical condition