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

NCT02962388 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2021-06-29

No results posted yet for this study

Summary

Prospective national multicenter randomized open label phase IIb RUXBETA trial.

Conditions

  • Essential Thrombocythemia

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Stéphane GIRAUDIER, MD PD · France Intergroupe Syndromes Myéloprolifératifs

  • LYDIA ROY, MD · France Intergroupe Syndromes Myéloprolifératifs

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-03
Primary Completion
2021-06-28
Completion
2021-06-28

Countries

  • France

Study Locations

More Related Trials

Entities

Companies

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 NCT02962388 on ClinicalTrials.gov