Study of Methotrexate Added to Current Therapy for Myeloproliferative Neoplasms Including Myelofibrosis, Polycythemia Vera, and Essential Thrombocythemia

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 MTXs effects and tolerability in this patient population.

MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trial