TerminatedPhase 1

Maintenance Fedratinib to Prevent Post-Transplant Relapse in Myeloproliferative Neoplasms

Stopped: Did not advance to Phase 2

United States12 participantsStarted 2022-03-14

Plain-language summary

The purpose of the study is to evaluate the effectiveness and safety of fedratinib as maintenance therapy in participants with myeloproliferative neoplasms (MPNs) after allogeneic hematopoietic cell transplant (HCT).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Have a negative pregnancy tests as verified by the Investigator during screening prior to enrollment (a second pregnancy test will be collected prior to therapy as below). She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence\* from heterosexual contact.
. Either commit to true abstinence\* from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use and be able to comply with highly effective contraception\*\* without interruption, -14 days prior to starting investigational product, during the study treatment (including dose interruptions), and for 30 days after discontinuation of study treatment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase 1: Recommended Phase 2 Dose

Timeframe: Up to 1 year

Phase 2: Progression Free Survival

Timeframe: at 1 year

Trial details

NCT IDNCT05127174

SponsorH. Lee Moffitt Cancer Center and Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-03

View on ClinicalTrials.gov More Myeloproliferative Neoplasm trials