Momelotinib + Luspatercept for Myelofibrosis
(ODYSSEY Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: GlaxoSmithKline
No Placebo Group
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.
Research Team
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 am 18 years old or older.
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.
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Treatment Details
Interventions
- Luspatercept (Growth Factor)
- Momelotinib (JAK Inhibitor)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Momelotinib + LuspaterceptExperimental Treatment2 Interventions
Participants with transfusion dependent primary myelofibrosis or post- PV/ ET myelofibrosis that is JAKi naïve or JAKi experienced will receive momelotinib and luspatercept.
Find a Clinic Near You
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