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A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial)

The ReTreatment Trial: A Phase II, Open-label, Single-arm Study of Re-treating Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event.

NCT02091752•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The aim of the study is to assess the efficacy and safety of restarting ruxolitinib after treatment interruption due to loss of response and/or adverse events.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Confirmed diagnosis of PMF, PPV MF or PET-MF, irrespective of JAK2 mutational status according to the 2008 revised International Standard Criteria
•Peripheral blast count \< 10%
•Requires therapy for MF in the opinion of the investigator
•Received prior monotherapy treatment with ruxolitinib for at least 12 consecutive weeks and experienced treatment interruption because of lossof response or adverse event
•Patients adhering to the Screening phase assessments and undergoing a a ruxolitinib-free washout period of a minimum of 1 week and a maximum of 8 weeks
•ECOG performance status 0, 1, 2, or 3
•Adequate bone marrow function
•Written informed consent

Exclusion Criteria

•Patients not initially responding (primary resistance) to ruxolitinib therapy
•Patients who underwent a splenectomy or spleen radiation
•Patients currently scheduled for bone marrow transplant
•Patients who have discontinued ruxolitinib \< 14 days prior to screening
•Patients who are not able to receive a starting dose of ruxolitinib of at least 15 mg total daily dose
•Leukemic transformation
•Inadequate renal function
•Presence of clinically meaningful active bacterial, fungal, parasitic or viral infection which requires therapy
•Previous history of Progressive Multifocal Leuko-encephalopathy (PML)
•Clinically significant cardiac disease or significant concurrent medical condition

Locations (3)

Novartis Investigative Site

Leipzig, Germany

Novartis Investigative Site

Florence, FI, Italy

Novartis Investigative Site

Madrid, Madrid, Spain

Key Dates

Start Date

September 1, 2014

Primary Completion Date

February 1, 2015

Completion Date

February 1, 2015

Last Updated

March 24, 2016

Enrollment

ACTUAL participants

Conditions

Primary Myelofibrosis

Interventions

Ruxolitinib

DRUG

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

View study

ACTIVE_NOT_RECRUITINGPHASE1

Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

NCT04279847

MyelofibrosisMyelodysplastic Syndrome+5 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: March 24, 2016Data 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.

View ClinicalTrials.gov Terms and Conditions

A Phase II Study of Re-treatment of Myelofibrosis Patients With Ruxolitinib/Jakavi After Treatment Interruption Due to Loss of Response and/or Adverse Event (ReTreatment Trial)

Inclusion Criteria

Exclusion Criteria

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)

Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)

A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)

Managed Access Programs for INC424, Ruxolitinib

A Phase 1/2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Hematologic and Myeloproliferative Malignancies