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NCT06541249 · ClinicalTrials.gov registry record · Phase 2
MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trial
A Phase 2 study of Myelofibrosis (MF) and Polycythemia Vera (PV), sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT06541249: Recruiting Phase 2 study of Myelofibrosis (MF) and Polycythemia Vera (PV), sponsored by Icahn School of Medicine at Mount Sinai.
NCT06541249 is a Phase 2 study of Myelofibrosis (MF) and Polycythemia Vera (PV) that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 54 participants, below the 977-participant average among 6 other Myelofibrosis (MF) trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06541249, a Phase 2 study of Myelofibrosis (MF) and Polycythemia Vera (PV), is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Methotrexate (MTX)
Study Locations (1)
New York
- Ruttenberg Treatment Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2024-10-02 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT06541249 shows while recruiting
NCT06541249 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 977-participant average among 6 other Myelofibrosis (MF) trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Myelofibrosis (MF) appearing as the primary indexed condition, and to 1 intervention - of which Methotrexate (MTX) is the first listed.
NCT06541249 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06541249 about?
NCT06541249 is a clinical study titled "MethoTRExATE in MyelOpRolifErative Neoplasms (TREATMORE) Trial". 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...
What is the current status of trial NCT06541249?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2024-10-02. Estimated completion is 2027-12.
What conditions does trial NCT06541249 study?
This clinical trial studies the following conditions: Myelofibrosis (MF), Polycythemia Vera (PV), Essential Thrombocythemia (ET).
What interventions are being tested in trial NCT06541249?
The interventions under investigation include: Methotrexate (MTX) (DRUG).
Who is sponsoring clinical trial NCT06541249?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06541249 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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