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)

PHASE2TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Primary Myelofibrosis
Interventions
DRUG

Ruxolitinib

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.

Trial Locations (3)

28034

Novartis Investigative Site, Madrid

50134

Novartis Investigative Site, Florence

04103

Novartis Investigative Site, Leipzig

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY