MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trial

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06541249
Phase
PHASE2
Status
Recruiting
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Conditions

  • Essential Thrombocythemia (ET)
  • Myelofibrosis (MF)
  • Polycythemia Vera (PV)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methotrexate (MTX) — DRUG
    MTX has recently been identified as a dose-dependent JAK/STAT pathway inhibitor. 15mg will be given once a week orally.

Study Details

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.

Key Dates

Start date
Oct 2, 2024
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Myelofibrosis (MF)
    18 patients with MF will be enrolled
  • Experimental: Polycythemia vera (PV)
    18 patients with MF will be enrolled
  • Experimental: Essential thrombocythemia (ET)
    18 patients with MF will be enrolled

Primary Outcome Measure

MF Overall response rate [ Time Frame: at 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ruttenberg Treatment CenterNew YorkNew York10029-

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By research site
Ruttenberg Treatment Center· New York, NY

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