Momelotinib + Luspatercept for Myelofibrosis

(ODYSSEY Trial)

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: GlaxoSmithKline

Must not be taking: Steroids, CYP3A4 inducers, ESAs

Disqualifiers: Invasive malignancy, Uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

56 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this Phase 2 study is to evaluate the efficacy and safety of momelotinib (MMB) in combination with luspatercept (LUSPA) in participants with transfusion dependence (TD) primary myelofibrosis (PMF) or Post-polycythemia vera (PV)/ essential thrombocythemia (ET) myelofibrosis (MF) who are either janus kinase (JAK) inhibitor (JAKi) naïve or experienced.

Will I have to stop taking my current medications?

The trial requires that you stop any active anti-myelofibrosis therapy at least 1 week before starting the study. Steroids for myelofibrosis must be stopped 14 days before the study, and certain other medications like potent CYP3A4 inducers should be stopped 14 days prior. Please consult with the study team for guidance on other medications.

Eligibility Criteria

This trial is for adults over 18 with high to intermediate risk primary myelofibrosis or post-PV/ET myelofibrosis, as per specific criteria. Participants can be new to JAK inhibitor treatment or have had previous treatments but must require regular blood transfusions due to low hemoglobin levels.

Inclusion Criteria

I have been diagnosed with PMF or myelofibrosis following PV/ET, according to WHO or IWG-MRT standards.

I have taken JAK inhibitors for myelofibrosis, or stopped due to side effects or needing blood transfusions.

My condition is classified as high or intermediate risk by DIPSS standards.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive momelotinib and luspatercept for the treatment of transfusion dependent myelofibrosis

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Luspatercept
• Momelotinib

Trial Overview The study tests the combination of two drugs, Momelotinib and Luspatercept, in patients who depend on transfusions due to myelofibrosis. It aims to see if this drug duo is effective and safe for those who are either new or experienced with JAK inhibitor therapies.

Participant Groups

Group I: Momelotinib + Luspatercept Experimental Treatment 2 Interventions

Participants with transfusion dependent primary myelofibrosis or post- PV/ ET myelofibrosis that is JAKi naïve or JAKi experienced will receive momelotinib and luspatercept.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

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Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School