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)

• Status: Terminated
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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