Actively Recruiting
MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trial
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-12-17
54
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating low-dose Methotrexate (MTX), a widely used and affordable therapy, as an additional treatment for patients with myeloproliferative neoplasms (MPNs) including myelofibrosis (MF), polycythemia vera (PV), and essential thrombocythemia (ET). MTX has recently been identified as a type 2 JAK inhibitor, and this study aims to assess its safety, tolerability, and clinical activity in combination with current therapies. The study could have significant impact on patients who cannot access or afford newer JAK inhibitors, especially in public and global health contexts. Participants will receive MTX orally once a week at a dose of 15 mg. The trial includes three groups: patients with MF, PV, and ET, with 18 patients enrolled per group. Eligible patients must have stable doses of current MPN therapies for at least 12 weeks but still have clinical or blood abnormalities. The study will evaluate responses related to spleen size, symptoms, and blood counts, along with pharmacokinetic and disease-modifying effects of MTX. During the study, participants will undergo regular assessments including symptom scoring, spleen evaluations, blood tests, and monitoring for adverse events for up to 48 weeks. The primary outcomes measured at 24 weeks include overall response rates for MF, PV, and ET. Secondary outcomes will track safety, symptom improvement, spleen and anemia response, and changes in blood parameters. The total participation time varies, with close monitoring throughout to capture MTX's effects and tolerability in this patient population.
CONDITIONS
Brief Title
MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older at the time of signing the informed consent form
- Willingly sign informed consent and able to follow study visits and protocol requirements
- Have a pathologically confirmed diagnosis of polycythemia vera, essential thrombocythemia, primary myelofibrosis, post-ET myelofibrosis, or post-PV myelofibrosis according to WHO criteria
- For MF patients, have low to high-risk disease by DIPSS; for PV and ET patients, include both low- and high-risk disease
- Have received at least 12 weeks of stable current MPN therapy with ongoing clinical symptoms or blood abnormalities
- Clinical burden defined as symptom assessment score greater than 12 points and/or palpable spleen of 5 cm or more
- Cytologic abnormalities including persistent leukocytosis or thrombocytosis as specified per disease type
- Allowed concurrent MPN therapies include aspirin, hydroxyurea, anagrelide, ropeginterferon alfa-2b, peginterferon alfa-2a, erythropoiesis-stimulating agents, phlebotomy, and/or ruxolitinib
- Stable dose for at least 12 weeks without changes
- Adequate organ function including liver enzymes, bilirubin, kidney clearance, platelet count, neutrophil count, and peripheral blood blast count
- ECOG performance status of 0 to 2
- Life expectancy of at least six months
- Women of childbearing potential must have negative pregnancy tests and agree to use contraception during and six months after the study
- Men must agree to use contraception during and 120 days after treatment
You will not qualify if you...
- Currently participating in another investigational study or received investigational therapy within 4 weeks
- Prescribed Methotrexate for a condition other than this study
- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring treatment within the last 6 months
- Other invasive cancers within the last 3 years except certain skin and localized cancers
- Moderate or severe cardiovascular disease including recent myocardial infarction, unstable angina, severe heart failure, uncontrolled hypertension, or major ECG abnormalities
- Organ transplant recipient other than bone marrow transplant
- Active serious infections
- Known untreated hepatitis B or C infection
- History of pulmonary fibrosis or interstitial pneumonitis
- History of chronic pericardial, pleural effusions, or ascites
- History of cirrhosis or heavy alcohol use
- Gastrointestinal diseases affecting Methotrexate absorption or unresolved nausea, vomiting, or diarrhea
- History of tuberculosis or severe fungal infection
- Taking medications contraindicated with Methotrexate
- Pregnant or breastfeeding women or planning pregnancy during the trial
- Serious unstable medical or psychiatric conditions preventing informed consent or posing unacceptable risk
- Immediate family member involved in the trial unless approved by IRB
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive Methotrexate (MTX) 15mg orally once a week as part of the treatment for their myeloproliferative neoplasm.
Weekly visits for up to 48 weeks
Trial Site Locations
Total: 1 location
1
Ruttenberg Treatment Center
New York, New York, United States, 10029
Actively Recruiting
Research Team
G
Gabriela Bello
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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