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The Ruxolitinib Versus Best Available Therapy Trial in Patients With High Risk ET in Second Line | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

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

NCT02962388•French Innovative Leukemia Organisation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 74 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Target Population
•Men and women, age more than or equal18 years and less than 75 years.
•Confirmed diagnosis of Essential Thrombocythemia for at least 6 months, according to the 2008 WHO criteria, with a high-risk status.
•Patients must have a treatment history for ET that meet the definition of resistance or intolerance to hydroxyurea therapy according to the ELN criteria as follow:
•* Platelets more than 600.0109/L after 3 months (12 weeks) of treatment at a dose over 2g/day.
•* Platelets more than 400.0 109/L and WBC less than 2.5109/L, whatever the dose of HU.
•* Platelets more than 400.0 109/L and Hb less than 10g/dl whatever the dose of HU.
•* Leg ulcers or other unacceptable muco-cutaneous toxicity.
•* HU-related fever.
•ECOG Performance Status (ECOG PS) less than or equal 2 at screening and at baseline.
+10 more criteria

Exclusion Criteria

•Patients with thrombocytosis related to another MPN than ET
•Patients previously treated with a JAK2 inhibitor, Anagrelide or Interferon-alpha and prior history of therapy other than Hydroxyurea
•Contraindication to Ruxolitinib, Anagrelide or Interferon-alpha (if no eligible for anagrelide), hypersensitivity to an excipient
•Medical history and concurrent diseases:
•Clinically significant cardiac disease (NYHA Class III or IV).
•Chronic hepatocellular disease.
•Subjects with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Ruxolitinib
•Subjects with clinically significant bacterial, fungal, parasitic or viral infection which requires therapy:
•* Subjects with acute bacterial infections requiring antibiotic use should delay screening/enrolment until the course of antibiotic therapy has been completed.
•* Subjects with active hepatitis A, B or C or with HIV positivity at screening.
+13 more criteria

Locations (1)

FILO

Tours, France

Key Dates

Start Date

January 3, 2017

Primary Completion Date

June 28, 2021

Completion Date

June 28, 2021

Last Updated

June 29, 2021

Enrollment

ACTUAL participants

Conditions

Essential Thrombocythemia

Interventions

Anagrelide

DRUG

Ruxolitinib (JAKAVI®)

DRUG

IFNα/ PegIFNα

DRUG

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

NCT06456346

Essential Thrombocythemia

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RECRUITINGPHASE1

A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)

NCT06343805

Primary MyelofibrosisPost-Essential Thrombocythemia Myelofibrosis+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)

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