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

NCT01644110 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University of Ulm

    lead OTHER

Principal Investigators

  • Konstanz Doehner, MD · University of Ulm

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2024-04-30
Completion
2024-04-27

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01644110 on ClinicalTrials.gov