Study on Momelotinib and Luspatercept for Patients with Transfusion Dependent Myelofibrosis
Sponsor: GlaxoSmithKline
ClinicalTrials ID:NCT06517875
This clinical trial is testing a combination of two drugs, momelotinib and luspatercept, to see if they are safe and effective for patients with myelofibrosis who need regular blood transfusions. The study includes patients who have or have not previously used JAK inhibitors.
Patient Parameters
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Program Overview
The purpose of this Phase 2 study is to evaluate how well the drugs momelotinib and luspatercept work together in treating patients with myelofibrosis who depend on blood transfusions. This includes patients with primary myelofibrosis or myelofibrosis that developed after other blood disorders, and who may or may not have used JAK inhibitors before.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of primary myelofibrosis or myelofibrosis that developed after polycythemia vera or essential thrombocythemia.
- Either have never used JAK inhibitors or have used them for at least 90 days, or 28 days if they caused a need for frequent blood transfusions or severe side effects.
- Be at high, intermediate-2, or intermediate-1 risk according to specific scoring systems.
- Require regular blood transfusions or have low hemoglobin levels before starting the study treatment.
Exclusion Criteria
- Have a history of certain intestinal or stomach diseases that affect medication absorption.
- Have had another invasive cancer within the last 5 years.
- Have anemia due to specific deficiencies or conditions like iron deficiency or thalassemia.
- Have uncontrolled infections or liver disease.
- Have uncontrolled high blood pressure.
- Have had certain heart conditions or strokes in the last 6 months.
- Have a prolonged QT interval on an ECG.
- Have a history of porphyria or significant nerve damage.
- Have used certain treatments or medications recently, including other myelofibrosis therapies or investigational drugs.
- Have had a splenectomy or previous treatment with momelotinib or luspatercept.
- Be unable to follow study rules or have unresolved side effects from previous treatments.
- Have certain viral infections like HIV or active hepatitis.
- Be pregnant or breastfeeding.
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