NCT06541249 MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trial
| NCT ID | NCT06541249 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Polycythemia Vera (PV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2024-10-02 |
| Primary Completion | 2027-06 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria * 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 d