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
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Low-dose MTX is a widely used, inexpensive, and safe therapy used for decades and is well tolerated by patients with rheumatologic diseases. Recently, it was identified as a type 2 JAK inhibitor. If MTX proves to be safe and tolerable with a signal of clinical activity, this could have a significant benefit to patients with MPNs. Beyond the potential benefit of adding a type 2 JAK inhibitor to current therapy, this could signal the need to study MTX in MPNs further as a monotherapy. Discovering MTX as safe and clinically effective in MPNs could be profound on both a public health and global health scale for patients who are uninsured and cannot afford more expensive novel JAK inhibitors, or for those in countries where JAK inhibitors are not available. Accordingly, the research team deems it reasonable and prudent to assess the safety and efficacy of MTX in addition to current therapy for patients with MPN. The research team will evaluate patients for spleen responses, symptom responses, and cytologic responses. Correlative data will evaluate pharmacokinetic and disease modifying activity of MTX in MPNs to inform future clinical trials.
CONDITIONS
Official 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 time of signing the informed consent form
- Be willing and able to follow the study visit schedule and protocol requirements
- Have a confirmed diagnosis of PV, ET, PMF, post-ET-MF, or post-PV-MF by WHO criteria
- For MF, have low, intermediate 1, intermediate 2, or high-risk disease by DIPSS
- For PV and ET, have low- or high-risk disease
- Have received at least 12 weeks of stable MPN therapy with persistent clinical burden or cytologic abnormalities
- Clinical burden defined as MPN-SAF TSS >12 points and/or palpable spleen ≥5cm
- Cytologic abnormalities include persistent leukocytosis (WBC >12 x 10^9/L), therapeutic phlebotomy dependence, thrombocytosis (platelet count >500 x 10^9/L) depending on disease
- Permitted concurrent therapies include aspirin, hydroxyurea, anagrelide, ropeginterferon alfa-2b, peginterferon alfa-2a, erythropoiesis-stimulating agents, phlebotomy, and/or ruxolitinib
- Stable dose defined as 12 weeks without dose change
- MF patients must be on stable dose of ruxolitinib
- Adequate organ function: AST, ALT <3x ULN without cirrhosis; total bilirubin <3 mg/dL; creatinine clearance >40 mL/min
- Baseline platelet count >50 x 10^9/L for MF and >150 x 10^9/L for ET/PV
- Baseline absolute neutrophil count >1000
- Peripheral blood blast count <10%
- ECOG performance status ≤2
- Life expectancy of at least six months
- Female participants of childbearing potential must have negative pregnancy tests and agree to use effective contraception during and 6 months after study
- Male participants must agree to use contraception during and 120 days after study therapy
You will not qualify if you...
- Currently participating in or recently completed another investigational study within 4 weeks
- Use of methotrexate for another condition
- History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring treatment within last 6 months
- Other invasive cancers within last 3 years except certain skin, prostate, or cervical cancers
- Moderate or severe cardiovascular disease including recent myocardial infarction, unstable angina, advanced heart failure, or uncontrolled hypertension
- Major ECG abnormalities unresponsive to treatment
- Organ transplant recipients except 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 ongoing nausea, vomiting, diarrhea above grade 1
- History of tuberculosis or severe fungal infection
- Use of medications contraindicated with methotrexate
- Pregnant or breastfeeding women or planning pregnancy
- Serious unstable medical or psychiatric conditions preventing informed consent or safe participation
- Immediate family members involved in the trial unless approved by IRB
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruttenberg Treatment Center
New York, New York, United States, 10029
Actively Recruiting
Research Team
G
Gabriela Bello
CONTACT
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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