NCT01644110

Ruxolitinib and Pomalidomide Combination Therapy in Patients With Primary and Secondary MF

A Phase-Ib/II Study of Ruxolitinib and Pomalidomide Combination Therapy in Patients With Primary and Secondary Myelofibrosis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is an open-label, single-arm, Phase-Ib/II trial to assess the efficacy of oral drug combination ruxolitinib and pomalidomide in primary and secondary MF patients.

Detailed description

The proposed study is an open-label, single-arm, Phase-Ib/II trial to assess the efficacy of oral drug combination ruxolitinib and pomalidomide in primary and secondary MF patients. Dosages of the drugs are derived from previous Phase-I/II studies; ruxolitinib treatment will be started at 10 mg twice daily, whereas the dose of pomalidomide will be 0.5 mg once daily. Dose reductions and discontinuations will be allowed in case of myelosuppressive effects. Intra-patient dose escalation will be permitted for ruxolitinib to optimize efficacy of the therapeutic regimen; pomalidomide will be given in a permanent dosage of 0.5mg per day. Treatment response will be evaluated continuously after each treatment cycle (1 cycle = 28 days) according to the IWG-MRT criteria expanded by the response criterion RCT-independency. In case of progressive disease study therapy will be stopped; In patients showing response or stable disease, continuous therapy within the study is intended for a maximum of 12 treatment cycles; After completion of 12 treatment cycles, therapy can be continued if a measurable benefit of treatment is evident. This extension has to be discussed between the local and the principle investigator. Conditions leading to patient withdrawal from the study are detailed in the protocol "PATIENT WITHDRAWAL FROM STUDY PARTICIPATION".

Conditions

• Primary Myelofibrosis
• Secondary Myelofibrosis
• PMF
• SMF
• Post-PV MF
• Post-ET MF

Interventions

Type	Name	Description
DRUG	INCB018424/CC-4047	Cohort 1: For patients (1-41) the starting dose of ruxolitinib in this trial is 10 mg twice daily po; pomalidomide will be administered at a permanent dose of 0.5 mg po once daily. Cohort 2: For patients (42-90) the starting dose of ruxolitinib in this trial is 10 mg twice daily po; the starting dose of pomalidomide is 0.5 mg po once daily.

Timeline

• Start date: 2013-08-01
• Primary completion: 2024-04-01
• Completion: 2024-04-27
• First posted: 2012-07-18
• Last updated: 2025-03-30

Locations

17 sites across 1 country: Germany