NCT02962388

The Ruxolitinib Versus Best Available Therapy Trial in Patients With High Risk ET in Second Line

A Randomized, Multicenter Phase IIb Study to Evaluate the Efficacy and Safety of Ruxolitinib Versus Best Available Therapy in Patients With High Risk Essential Thrombocythemia, Who Are Resistant or Intolerant to Hydroxyurea: A FIM Study

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: French Innovative Leukemia Organisation · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

Prospective national multicenter randomized open label phase IIb RUXBETA trial.

Detailed description

A randomized, open label, multicenter phase IIb study to evaluate the efficacy and safety of Ruxolitinib versus best available therapy in patients with high risk essential thrombocythemia, who are resistant or intolerant to hydroxyurea.

Conditions

• Essential Thrombocythemia

Interventions

Type	Name	Description
DRUG	Anagrelide	Anagrelide in the study, according to the investigator decision fom day 1 to 48 months
DRUG	Ruxolitinib (JAKAVI®)	Ruxolitinib (JAKAVI®) - Novartis. Tablets 5 mg. Starting dose 10 mg BID, orally. To be increased or decreased (5 or 10 mg steps) per standardized dosing Maximum dose 25 mg BID. fom day 1 to 48 months
DRUG	IFNα/ PegIFNα	IFNα/ PegIFNα in the study, according to the investigator decision fom day 1 to 48 months

Timeline

• Start date: 2017-01-03
• Primary completion: 2021-06-28
• Completion: 2021-06-28
• First posted: 2016-11-11
• Last updated: 2021-06-29

Locations

1 site across 1 country: France