Primary Myelofibrosis study: Momelotinib vs Luspatercept
Official title Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
ClinicalTrials.gov ID: NCT06517875
What this study is testing
What is Momelotinib?
Momelotinib is an investigational oral medicine being studied as a potential treatment for primary myelofibrosis and related myelofibrosis conditions. Momelotinib is designed to inhibit Janus kinase (JAK) signaling pathways that are overactive in myelofibrosis.
Also referred to as Ojjaara; CYT387.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether the combination of momelotinib and luspatercept works and is safe for people with transfusion‑dependent myelofibrosis.
- Who it's for
- You may be able to join if you have primary myelofibrosis or post‑PV/ET myelofibrosis and need regular blood transfusions, whether or not you have taken a JAK inhibitor before.
- What's involved
- You will take momelotinib, a daily pill, and luspatercept, a monthly injection. You will visit the clinic for safety checks and blood tests.
- Time commitment
- The study lasts several months and requires regular clinic visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Is age ≥18 years.
- Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post-PV/ET myelofibrosis in accordance with the...
- JAKi naïve or previously treated with either ruxolitinib or fedratinib for PMF or Post-PV/ET myelofibrosis for ≥90 days, or ≥28 days if JAKi therapy...
- High risk, intermediate-2, or intermediate-1 risk as defined by Dynamic International Prognostic Scoring System (DIPSS) [Passamonti, 2010] or...
- TD defined as requiring RBC transfusion ≥4 units or HgB \< 8 g/dL in the 8 weeks prior to the first dose of study treatment (NOTE: 2 consecutive Hgb...
You likely can't join if
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea...
- Participants with an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years.
- Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, gastrointestinal...
- Active uncontrolled infection (participants receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as...
- Significant active or chronic bleeding event ≥ Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, within 4 weeks prior to the...
- Uncontrolled acute and chronic liver disease (e.g., Child-Pugh score ≥10) OR has current unstable liver or biliary disease per investigator...
See the full eligibility criteria
- Is age ≥18 years.
- Confirmed diagnosis of PMF in accordance with the World Health Organization (WHO) 2016 criteria, or Post-PV/ET myelofibrosis in accordance with the International Working Group-Myeloproliferative Neoplasms Research and...
- JAKi naïve or previously treated with either ruxolitinib or fedratinib for PMF or Post-PV/ET myelofibrosis for ≥90 days, or ≥28 days if JAKi therapy is complicated by RBC transfusion requirement of ≥4 units in 8 weeks...
- High risk, intermediate-2, or intermediate-1 risk as defined by Dynamic International Prognostic Scoring System (DIPSS) [Passamonti, 2010] or DIPSS-plus [Gangat, 2011].
- TD defined as requiring RBC transfusion ≥4 units or HgB \< 8 g/dL in the 8 weeks prior to the first dose of study treatment (NOTE: 2 consecutive Hgb \< 8 g/dL, at least 1 week apart are required
- History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study...
- Participants with an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years.
- Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, gastrointestinal bleeding, or thalassemia.
- Active uncontrolled infection (participants receiving outpatient antibacterial and/or antiviral treatments for infection that is under control or as infection prophylaxis may be included in the trial);
- Significant active or chronic bleeding event ≥ Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, within 4 weeks prior to the first dose of study treatment; or
- Uncontrolled acute and chronic liver disease (e.g., Child-Pugh score ≥10) OR has current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy...
- Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, that is not resolved at the time of the first dose of study treatment.
- Unstable angina pectoris; OR
- Symptomatic congestive heart failure; OR
- Uncontrolled cardiac arrhythmia
- QTc interval \>450 msec or QTc \>480 msec for participants with bundle branch block.
- Participants with stroke, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to the first dose of study intervention.
- History of porphyria.
- Presence of peripheral neuropathy ≥Grade 2 per CTCAE v5.0.
- Active anti-MF therapy within 28 days or 5 half-lives, whichever is shorter (exception is prior JAKi therapy).
- Steroid use for the treatment of myelofibrosis is prohibited within 14 days prior to the first dose of study treatment until discontinuation of study treatment.
- Potent cytochrome P450 3A4 (CYP3A4) inducers, except for rifampin and rifampicin, within 14 days prior to the first dose of study intervention.
- Any prior investigational agent for myelofibrosis within 4 weeks prior to the first dose of study treatment.
- Erythropoiesis stimulating agent (ESA) within 4 weeks prior to the first dose of study treatment.
- Splenic irradiation within 3 months prior to the first dose of study treatment.
- Prior treatment with MMB.
- Prior treatment with TGF-β pathway ligand traps (e.g., luspatercept or sotatercept).
- Prior splenectomy.
- Inability or unwillingness to comply with the protocol restrictions on myelofibrosis therapy and other medications prior to and during study treatment.
- Unresolved non-hematologic toxicities from prior therapies that are \>Grade 1 per CTCAE v5.0 unless otherwise specified.
- Known positive status for human immunodeficiency virus (HIV).
- Chronic active or acute viral hepatitis A.
- Active Hepatitis B infection indicated by the presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to the first dose of study intervention.
- Positive hepatitis C antibody test result at screening or within 3 months before the first dose of study intervention.
- Women who are already pregnant or lactating.
The study team makes the final eligibility decision.
Where it is enrolling
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Lyon, Rhône, France
- Angers, France
- Brest, France
- Nice, France
- Nîmes, France
- Paris, France
- Poitiers, France
- Essen, North Rhine-Westphalia, Germany
- Jena, Thuringia, Germany
- Lübeck, Germany
- Mannheim, Germany
- Milan, MI, Italy
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Ann Arbor, Michigan, United States; New York, New York, United States; Nashville, Tennessee, United States; Houston, Texas, United States; Seattle, Washington, United States; Vancouver, British Columbia, Canada and 25 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.