MyelofibrosisPhase 4APEX-MFNCT07498205
Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts
A Phase 4 study testing Momelotinib and Ruxolitinib in people with Myelofibrosis and Myelofibrosis (MF), run by SWOG Cancer Research Network.
Trial summary
The purpose of this study is to compare momelotinib and ruxolitinib as treatments for myelofibrosis with low blood cell counts. Both drugs are approved by the FDA to treat myelofibrosis. The study asks which drug does a better job at shrinking the spleen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis, Myelofibrosis (MF)
- What is being tested?
- Momelotinib and Ruxolitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to 8 Aug 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera (PV) MF or post-essential thrombocythemia (ET) MF as assessed by the treating physician per 2022 WHO classification, and confirmed by a bone marrow biopsy within four years.
- Participants must have a spleen measuring ≥ 450 cm3 by MRI within 14 days prior to Step 1 registration. For participants with a medical contraindication to MRI or if MRI is unavailable, a CT scan may be performed.
- Participants must have DIPSS risk category of Intermediate-1, Intermediate-2 or High per Dynamic International Prognostic Scoring System (DIPSS) for MF.
- Participants must have blasts <10% in peripheral blood within 28 days of Step 1 registration. If bone marrow biopsy performed within 28 days prior to Step 1 registration blasts must be <10% as well.
- Participants must have discontinued all drugs used to treat MF, including hydroxyurea, peginterferon alfa-2a, ropeginterferon alfa-2b, anagrelide or busulfan ≥ 14 days prior to Step 1 registration.
- Participants must be ≥ 18 years old at the time of registration.
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- Participants must have Zubrod/ECOG Performance Status of 0-2.
- Participants must have a complete medical history and physical exam within 28 days prior to Step 1 registration.
- Participants must meet hematologic parameters within 28 days prior to Step 1 registration.
- Participants must have a calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to Step 1 registration. For creatinine clearance formula see the tools on the CRA Workbench https://txwb.crab.org/TXWB/Tools.aspx.
- Participants must be able to take orally administered medication and comply with the oral regimen.
- Participants with a history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at Step 1 registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to Step 1 registration.
- Participants with a history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to Step 1 registration, if indicated.
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to Step 1 registration, if indicated.
- Participants must be offered the opportunity to participate in specimen banking.
- Participants who can complete PRO and QOL questionnaires in English or Spanish languages must agree to participate in the patient-reported outcomes and quality of life questionnaires.
- Participants or their legally authorized representative must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and WCG IRB regulations.
- Participants must have met one or more of the following criteria on Registration Step 1:
- Spleen volume decrease <10% or spleen volume increase of any volume from baseline MRI (or CT) in response to initial treatment (momelotinib or ruxolitinib) from baseline MRI (or CT) at week 24.
- ≥ 3 units of RBC transfusions during any rolling 8-week period starting at or after week 16 preceding Step 2 registration OR hemoglobin < 8 g/dL on two consecutive measurements at least 1 week apart during any rolling 8-week period starting at or after week 16 preceding Step 2 registration.
- Unacceptable toxicities attributed to initial treatment (momelotinib or ruxolitinib) of grade ≥ 3 (or grade < 3 if determined clinically significant by treating physician) as determined by treating physician.
- Unable to maintain total daily ruxolitinib dose ≥ 20 mg due to cytopenias or intolerance (crossover to momelotinib only).
- Participants must be able to safely receive the crossover drug (either momelotinib or ruxolitinib) in the opinion of the treating investigator.
- Participants must have adequate organ and marrow function within 14 days prior to Step 2 registration.
- Participants must have a calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 14 days prior to Step 2 registration. For creatinine clearance formula see the tools on the CRA Workbench https://txwb.crab.org/TXWB/Tools.aspx.
Who cannot join
- Participants must have discontinued all drugs used to treat MF, including hydroxyurea, peginterferon alfa-2a, ropeginterferon alfa-2b, anagrelide or busulfan ≥ 14 days prior to Step 1 registration.
- Participants must not be considered eligible for hematopoietic stem cell transplantation (HSCT) or have prior HSCT for MF.
- Participants must not have received prior JAK or ACVR1 inhibitor treatment.
- Participants must not have received investigational therapy within 14 days prior to Step 1 registration.
- Participants must not have had a prior splenectomy.
- Participants must not have had splenic irradiation within 90 days prior to Step 1 registration.
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- Participants must not have received prior chemotherapy for their MF (e.g., hypomethylating agent, hypomethylating agent + venetoclax).
- Participants must not have had major surgery within 21 days prior to Step 1 registration.
- Participants must not have received a live vaccine within 14 days prior to Step 1 registration.
- Participants must not have grade 2 or higher peripheral neuropathy.
- Participants must not have clinically significant cardiac disease (New York Heart Association Class III or IV); symptomatic congestive heart failure; or unstable angina pectoris. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.
- Participants must not have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- Participants must not have history of stroke, reversible ischemic neurologic deficit, or transient ischemic attack within 90 days prior to Step 1 registration.
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Participants with curatively treated basal or squamous cell skin cancer, superficial bladder cancer, in situ cervical cancer and/or in situ breast cancer may be enrolled.
- Participants must not have uncontrolled systemic fungal, bacterial, viral or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) as determined by the local investigator.
- Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
- Registration Step 2: Optional Crossover for All Participants after Week 24 Assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Open Label Trial Comparing Momelotinib vs Dose-Adjusted Ruxolitinib For Treatment-Naive, Cytopenic Myelofibrosis
The purpose of this study is to compare momelotinib and ruxolitinib as treatments for myelofibrosis with low blood cell counts. Both drugs are approved by the FDA to treat myelofibrosis. The study asks which drug does a better job at shrinking the spleen.
Read the detailed description
This study is being done to answer this question:
Does momelotinib or ruxolitinib do a better job at shrinking the spleen in people who have myelofibrosis with low blood cell counts and haven't been treated yet?
Other goals of this study are to find out:
- Which drug does a better job of preventing the need for blood transfusions or other treatments
- Which drug does a better job of reducing myelofibrosis symptoms
- What side effects the drugs cause
Momelotinib and ruxolitinib are JAK inhibitors. JAK inhibitors are medicines that block a type of protein that can cause the immune system to be too active, which can cause pain and swelling (including in the spleen). JAK inhibitors are the most commonly used drugs for myelofibrosis that has caused serious symptoms including swelling in the spleen.
There are many different JAK inhibitors approved by the FDA to treat myelofibrosis, but no previous studies have compared these drugs with each other for treating myelofibrosis in people with low blood cell counts who haven't been treated yet.
- Conditions
- Myelofibrosis, Myelofibrosis (MF)
- Being tested
- Momelotinib, Ruxolitinib
- Keywords
- Myelofibrosis, momelotinib, ruxolitinib
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MomelotinibDrug
Also called JAK-inihibitor
200 mg daily x 96 weeks.
RuxolitinibDrug
Also called JAK-inihibitor
Twice daily per treating investigator discretion not to exceed protocol specified guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Momelotinib | Active comparator | Momelotinib Receives: Drug: Momelotinib |
| Ruxolitinib | Active comparator | Ruxolitinib Receives: Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate and compare the proportion of participants achieving a dual response [SVR35] and transfusion independence response from red blood cell transfusions.
To estimate and compare the proportion of patients achieving a dual response both spleen response [SVR35] and transfusion independence response [TI-R] from red blood cell transfusions at week 24 post-Step 1 randomization in JAK-inhibitor naïve participants with myelofibrosis treated with momelotinib versus ruxolitinib.
Measured: 24 weeks after randomization
Secondary outcomes (14)
TI-R Rate
To estimate and compare the TI-R rate at week 24, post-Step 1 randomization in each treatment arm.
Measured: 24 weeks after Step 1 Randomization
SVR35 at week 24 post-randomization
To estimate and compare the rates of SVR35 at week 24 post-randomization in each treatment arm.
Measured: 24 weeks after Step 1 Randomization
OS
To estimate overall survival (OS) in each treatment arm.
Measured: 96 weeks after Step 1 Randomization
PFS
To estimate progression-free survival (PFS) in each treatment arm.
Measured: 96 weeks after Step 1 Randomization
SVR35 at week 24 post-randomization
To estimate and compare SVR35 at week 24 post-randomization in each treatment arm with a sensitivity analysis based on a modeled version of the continuous spleen response rate.
Measured: 24 weeks after Step 1 Randomization
Allogeneic Transplantation
To tabulate the proportion of participants in each arm who undergo allogeneic transplantation at week 24 and week 48 post-Step 1 randomization.
Measured: 96 weeks after Step 1 Randomization
Cross-over
To tabulate the number of participants on each arm who cross over.
Measured: 72 weeks after Step 1 Randomization
Time to next non-protocol treatment
To estimate and compare the time to next non-protocol treatment (excludes crossover) in each treatment arm.
Measured: 96 weeks after Step 1 Randomization
SVR35
To estimate and compare the rates of SVR35 at week 48 post-Step 1 randomization by treatment arm and stratified by cross-over-status.
Measured: 48 weeks after Step 1 Randomization
TI-R
To estimate and compare the rates of TI-R at week 48 post-Step 1 randomization by treatment arm and stratified by cross-over-status.
Measured: 48 weeks after Step 1 Randomization
Dual Response
To estimate and compare the rates of dual response (SVR35 + TI-R) at week 48 post-Step 1 randomization by treatment arm and stratified by cross-over-status.
Measured: 48 weeks after Step 1 Randomization
To estimate the frequency of and severity of toxicities in each treatment arm
To estimate and compare the frequency of major anemia response per 2024 IWG-ELN criteria in each treatment arm by week 24 and by week 48 (week 48 stratified by cross-over-status).
Measured: 48 weeks after Step 1 Randomization
Major anemia response
To estimate and compare the frequency of major anemia response per 2024 IWG-ELN criteria in each treatment arm by week 24 and by week 48 (week 48 stratified by cross-over-status).
Measured: 48 weeks after Step 1 Randomization
Time to initiation of anemia-directed therapy
To estimate and compare the time to initiation of anemia-directed therapy in each treatment arm among participants not on anemia-directed therapy at registration by week 24 and by week 48 (week 48 stratified by cross-over-status).
Measured: 48 weeks after Step 1 Randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study startNov 2026 (estimated)
- Primary completion8 Aug 2029 (estimated)
- Study completion8 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Alexander Coltoff, MD, Principal investigator, SWOG Network Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498205
- Sponsor's protocol ID
- 26CTP.LEUK02
- Acronym
- APEX-MF
- Status last verified
- Sep 2026
- First submitted
- 20 Mar 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Label Trial Comparing Momelotinib vs Dose-Adjusted Ruxolitinib For Treatment-Naive, Cytopenic Myelofibrosis
- ClinicalTrials.gov ID
- NCT07498205
- Acronym / sponsor ID
- APEX-MF / 26CTP.LEUK02
- Conditions
- Myelofibrosis, Myelofibrosis (MF)
- Keywords
- Myelofibrosis, momelotinib, ruxolitinib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2026 (estimated)
- Primary completion
- 8 Aug 2029 (estimated)
- Study completion
- 8 Aug 2031 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare momelotinib and ruxolitinib as treatments for myelofibrosis with low blood cell counts. Both drugs are approved by the FDA to treat myelofibrosis. The study asks which drug does a better job at shrinking the spleen.
Detailed description
This study is being done to answer this question:
Does momelotinib or ruxolitinib do a better job at shrinking the spleen in people who have myelofibrosis with low blood cell counts and haven't been treated yet?
Other goals of this study are to find out:
- Which drug does a better job of preventing the need for blood transfusions or other treatments
- Which drug does a better job of reducing myelofibrosis symptoms
- What side effects the drugs cause
Momelotinib and ruxolitinib are JAK inhibitors. JAK inhibitors are medicines that block a type of protein that can cause the immune system to be too active, which can cause pain and swelling (including in the spleen). JAK inhibitors are the most commonly used drugs for myelofibrosis that has caused serious symptoms including swelling in the spleen.
There are many different JAK inhibitors approved by the FDA to treat myelofibrosis, but no previous studies have compared these drugs with each other for treating myelofibrosis in people with low blood cell counts who haven't been treated yet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Momelotinib | Active comparator | Drug: MomelotinibMomelotinib |
| Ruxolitinib | Active comparator | Drug: RuxolitinibRuxolitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Participants must have confirmed diagnosis of primary myelofibrosis (PMF), post-polycythemia vera (PV) MF or post-essential thrombocythemia (ET) MF as assessed by the treating physician per 2022 WHO classification, and confirmed by a bone marrow biopsy within four years.
- Participants must have a spleen measuring ≥ 450 cm3 by MRI within 14 days prior to Step 1 registration. For participants with a medical contraindication to MRI or if MRI is unavailable, a CT scan may be performed.
- Participants must have DIPSS risk category of Intermediate-1, Intermediate-2 or High per Dynamic International Prognostic Scoring System (DIPSS) for MF.
- Participants must have blasts <10% in peripheral blood within 28 days of Step 1 registration. If bone marrow biopsy performed within 28 days prior to Step 1 registration blasts must be <10% as well.
- Participants must have discontinued all drugs used to treat MF, including hydroxyurea, peginterferon alfa-2a, ropeginterferon alfa-2b, anagrelide or busulfan ≥ 14 days prior to Step 1 registration.
Key exclusion criteria (17 listed)
- Participants must have discontinued all drugs used to treat MF, including hydroxyurea, peginterferon alfa-2a, ropeginterferon alfa-2b, anagrelide or busulfan ≥ 14 days prior to Step 1 registration.
- Participants must not be considered eligible for hematopoietic stem cell transplantation (HSCT) or have prior HSCT for MF.
- Participants must not have received prior JAK or ACVR1 inhibitor treatment.
- Participants must not have received investigational therapy within 14 days prior to Step 1 registration.
- Participants must not have had a prior splenectomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MomelotinibAlso: JAK-inihibitor200 mg daily x 96 weeks. | Drug | Momelotinib |
| RuxolitinibAlso: JAK-inihibitorTwice daily per treating investigator discretion not to exceed protocol specified guidelines. | Drug | Ruxolitinib |
Primary outcome
To estimate and compare the proportion of participants achieving a dual response [SVR35] and transfusion independence response from red blood cell transfusions.
Time frame: 24 weeks after randomization
To estimate and compare the proportion of patients achieving a dual response both spleen response [SVR35] and transfusion independence response [TI-R] from red blood cell transfusions at week 24 post-Step 1 randomization in JAK-inhibitor naïve participants with myelofibrosis treated with momelotinib versus ruxolitinib.
14 secondary outcomes
TI-R Rate
Time frame: 24 weeks after Step 1 Randomization
SVR35 at week 24 post-randomization
Time frame: 24 weeks after Step 1 Randomization
OS
Time frame: 96 weeks after Step 1 Randomization
PFS
Time frame: 96 weeks after Step 1 Randomization
SVR35 at week 24 post-randomization
Time frame: 24 weeks after Step 1 Randomization
Allogeneic Transplantation
Time frame: 96 weeks after Step 1 Randomization
Cross-over
Time frame: 72 weeks after Step 1 Randomization
Time to next non-protocol treatment
Time frame: 96 weeks after Step 1 Randomization
SVR35
Time frame: 48 weeks after Step 1 Randomization
TI-R
Time frame: 48 weeks after Step 1 Randomization
Dual Response
Time frame: 48 weeks after Step 1 Randomization
To estimate the frequency of and severity of toxicities in each treatment arm
Time frame: 48 weeks after Step 1 Randomization
Major anemia response
Time frame: 48 weeks after Step 1 Randomization
Time to initiation of anemia-directed therapy
Time frame: 48 weeks after Step 1 Randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Coltoff, MD principal investigator
SWOG Network Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Momelotinib and Ruxolitinib in people with Myelofibrosis and Myelofibrosis (MF), run by SWOG Cancer Research Network.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SWOG Clinical Trials Partnerships SWOG Clinical Trials Partnerships (210-614-8808, ctp@swog.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate and compare the proportion of participants achieving a dual response [SVR35] and transfusion independence response from red blood cell transfusions. (time frame: 24 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.