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)

The ReTreatment Trial: A Phase II, Open-label, Single-arm Study of Re-treating Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event.

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.

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