Methotrexate for Myeloproliferative Neoplasms (TREATMORE) Trial
This study is testing Methotrexate (MTX) in people with certain blood cancers called Myeloproliferative Neoplasms (MPNs), specifically Polycythemia Vera (PV), Essential Thrombocythemia (ET), and Myelofibrosis (MF). MTX is a common, inexpensive drug that has recently been found to work in a way that might help with MPNs. You may be able to join if you are 18 or older, have a confirmed diagnosis of PV, ET, or MF, and are willing to follow the study plan. The main goal is to see how many people respond to MTX treatment after 24 weeks. The current recruitment status is unclear, but the study plans to enroll 54 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 54 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main study outcomes are measured at 24 weeks after treatment begins.
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NCT06541249
MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trial
Recruiting
PHASE2Ages 18+InterventionalTreatmentIcahn School of Medicine at Mount SinaiInvestigator-initiated
~54 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:Methotrexate (MTX)
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MF Overall response rate
Measured over at 24 weeks
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- John Mascarenhas · STUDY_CHAIR · Icahn School of Medicine at Mount Sinai
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Be ≥18 years of age at time of signing the informed consent form (ICF)
Must voluntarily sign ICF and be willing and able to adhere to the study visit schedule and all protocol requirements
Have a pathologically confirmed diagnosis of PV, ET, PMF, post-ET-MF, or post-PV-MF as per WHO diagnostic criteria
Participants with MF may have low, intermediate 1, intermediate 2, or high-risk disease by Dynamic International Prognostic Scoring System (DIPSS). Participants with PV and ET with both low- and high-risk disease may be included.
Must have received at least 12 weeks of current MPN therapy at stable doses and have persistent clinical burden and/or cytologic abnormalities as defined by the following:
Clinical burden is defined as MPN-SAF TSS \>12 points and/or palpable spleen of ≥5cm
Cytologic abnormalities include the following for each disease state:
MF:
Persistent leukocytosis as defined by WBC \>12 x 109/L
PV:
Persistent therapeutic phlebotomy dependence (\>2 phlebotomies within 24 weeks of screening, and \>1 phlebotomy within 16 weeks of screening, as defined in the PROUD-PV studies) for a goal HCT \<45% and/or
Leukocytosis as defined by WBC \>12 x 109/L and/or
Thrombocytosis defined as platelet count \>500 x 109/L
ET:
Persistent leukocytosis as defined by WBC \>12 x 109/L and/or
Thrombocytosis defined as platelet count \>500 x 109/L
Permitted concurrent MPN therapies include: aspirin, hydroxyurea, anagrelide, ropeginterferon alfa-2b, peginterferon alfa-2a, erythropoiesis-stimulating agents, phlebotomy, and/or ruxolitinib.
A stable dose is defined as 12 weeks of treatment without a change in dosing
Patients with myelofibrosis must be on stable dose of ruxolitinib
Must have adequate organ function as demonstrated by the following:
AST, ALT \<3x upper limit of normal (ULN) and no known history of cirrhosis
Total bilirubin \<3mg/dL
Creatinine clearance (CrCl) \>40 mL/min as estimated with the Cockcroft-Gault equation
Baseline platelet count \>50 x 109/L for MF and \>150 x 109/L for ET/PV
Baseline absolute neutrophil count (ANC) \>1000
Peripheral blood blast count \<10%
ECOG performance status ≤2
Life expectancy of at least six months
Female participants of childbearing potential must have a negative serum pregnancy test at screening and Cycle 1 Day 1 and must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Recommended methods of birth control are:
The consistent use of an approved hormonal contraception (birth control pill/patches, rings), an intrauterine device (IUD), contraceptive injection (Depo-Provera), double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), sexual abstinence (no sexual intercourse), or sterilization
A woman of childbearing potential is any woman (regardless of sexual orientation, having undergone a tubal litigation, or remaining celibate by choice) who meets the following criteria:
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months
Male participants must agree to use an adequate method of contraception and must not father a child or donate sperm starting with the first dose of study therapy through 120 days after the last dose of study therapy
Exclusion
Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
Prescribed MTX for another indication
History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months
Have other invasive malignancies within the last 3 years, except non-melanoma skin cancer and localized, cured prostate and cervical cancer
Have moderate or severe cardiovascular disease as defined by the following:
Have cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension
Have documented major ECG abnormalities (not responding to medical treatments)
Be an organ transplant recipient other than bone marrow transplant
Presence of active serious infection
Have a known history B, or untreated hepatitis C infection
Have a known history of pulmonary fibrosis, interstitial pneumonitis
Have a known history of chronic pericardial effusions, pleural effusions, or ascites
Have a known history of cirrhosis, or current heavy alcohol consumption
Have impairment of gastrointestinal function or gastrointestinal disease that could significantly alter the absorption of MTX, including any unresolved nausea, vomiting, or diarrhea \> CTCAE v5.0 grade 1
Have known history of tuberculosis or severe fungal infection
Is receiving specific concomitant medications that are contraindicated with MTX.
Women who are pregnant or lactating, or plan to become pregnant during trial period
Have any serious, unstable medical or psychiatric condition that would prevent (as judged by the Investigator) the participant from signing the informed consent form or any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or sponsor staff directly involved with this trial, unless prospective IRB approval (by chair or designee) is given allowing exception to this criterion for a specific participant
What this trial measures
- MF Overall response rateat 24 weeks
MF overall response rate, defined as Clinical Improvement (CI) or greater per the IWG-MRT and ELN Response Criteria for MF (2013). CI or greater is defined as changes in the spleen, hemoglobin, and symptoms.
- PV and ET Overall response rateat 24 weeks
PV overall response rate, defined as complete response (CR) or partial response (PR) by modified 2013 ELN criteria. CR response is defined as a lasting reduction in spleen size, symptom improvement, a reduction in platelet and white cell count. As well as changes in bone marrow biopsy. PR response is defined as lasting reduction in spleen size, symptom improvement, a reduction in platelet and white cell count.