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Anti-metabolites

Methotrexate for Myeloproliferative Disorders (TREATMORE Trial)

Phase 2
Recruiting
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status ≤2
Have a pathologically confirmed diagnosis of PV, ET, PMF, post-ET-MF, or post-PV-MF as per WHO diagnostic criteria
Must not have
Have moderate or severe cardiovascular disease as defined
Be an organ transplant recipient other than bone marrow transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study the safety and effectiveness of low-dose MTX in patients with MPNs. MTX, a type 2 JAK inhibitor, has been used for years to treat rhe

Who is the study for?
The TREATMORE trial is for patients with myeloproliferative disorders such as myelofibrosis, essential thrombocythemia, or polycythemia vera. Participants should be currently receiving therapy for their condition but are still looking for additional treatment options.
What is being tested?
This study tests low-dose Methotrexate (MTX), a medication traditionally used in rheumatologic diseases and recently identified as a type 2 JAK inhibitor. The trial will assess its safety, tolerability, and effectiveness when added to current therapies in MPNs.
What are the potential side effects?
Methotrexate may cause side effects like nausea, mouth sores, fatigue, liver issues (elevated liver enzymes), lung problems (pneumonitis), and increased risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I have been diagnosed with a specific type of blood disorder according to WHO criteria.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have moderate or severe heart disease.
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I have received an organ transplant, but not a bone marrow transplant.
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I have had tuberculosis or a severe fungal infection.
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I am taking medications that cannot be combined with MTX.
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I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.
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I currently have a serious infection.
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I have hepatitis B or untreated hepatitis C.
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I have a history of lung scarring or inflammation.
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I have a history of fluid build-up around my heart, lungs, or in my abdomen.
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I have a stomach or intestine problem that affects how my body absorbs medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MF Overall response rate
PV and ET Overall response rate
Secondary study objectives
Adverse event Grade
Anemia Response Rate
Change from baseline in dosing of cytoreductive agents (PV and ET Cohort)
+7 more

Side effects data

From 2020 Phase 4 trial • 14 Patients • NCT03635957
33%
Gout
13%
Nausea
13%
Abdominal Discomfort
7%
Cough
7%
Headache
7%
Nasopharyngitis
7%
Pruritus
7%
Dental Caries
7%
Dry Eye
7%
Diarrhoea
7%
Chronic Sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Run-In Period: MTX
Pegloticase + IMM Period: Pegloticase + MTX

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Polycythemia vera (PV)Experimental Treatment1 Intervention
18 patients with MF will be enrolled
Group II: Myelofibrosis (MF)Experimental Treatment1 Intervention
18 patients with MF will be enrolled
Group III: Essential thrombocythemia (ET)Experimental Treatment1 Intervention
18 patients with MF will be enrolled
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methotrexate (MTX)
2005
Completed Phase 4
~7010

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,751 Total Patients Enrolled
John MascarenhasStudy ChairIcahn School of Medicine at Mount Sinai
~36 spots leftby Jul 2027
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