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OncoMatch/Clinical Trials/NCT06541249

MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trial

Is NCT06541249 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Methotrexate (MTX) for polycythemia vera (pv).

Phase 2RecruitingIcahn School of Medicine at Mount SinaiNCT06541249Data as of May 2026

Treatment: Methotrexate (MTX)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.

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Extracted eligibility criteria

Cancer type

Myeloproliferative Neoplasm

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: myeloproliferative neoplasm therapy

Must have received at least 12 weeks of current MPN therapy at stable doses

Cannot have received: methotrexate (methotrexate)

Prescribed MTX for another indication

Cannot have received: investigational agent

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

Lab requirements

Blood counts

Baseline platelet count >50 x 10^9/L for MF and >150 x 10^9/L for ET/PV; Baseline absolute neutrophil count (ANC) >1000; Peripheral blood blast count <10%

Kidney function

Creatinine clearance (CrCl) >40 mL/min as estimated with the Cockcroft-Gault equation

Liver function

AST, ALT <3x upper limit of normal (ULN) and no known history of cirrhosis; Total bilirubin <3mg/dL

Must have adequate organ function as demonstrated by the following: AST, ALT <3x ULN and no known history of cirrhosis; Total bilirubin <3mg/dL; CrCl >40 mL/min; Baseline platelet count >50 x 10^9/L for MF and >150 x 10^9/L for ET/PV; Baseline ANC >1000; Peripheral blood blast count <10%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Ruttenberg Treatment Center · New York, New York

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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