Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541249
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
MethoTRExATE in MyelOpRolifErative Neoplasms TREATMORE Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
MethoTRExATE in MyelOpRolifErative Neoplasms TREATMORE Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREATMORE
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None