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Fedratinib for Myeloproliferative Disorders

Phase 1 & 2
Waitlist Available
Led By Hany Elmariah, MD, MS
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2
Philadelphia chromosome negative myeloproliferative disease having undergone first allogeneic HCT with specific engraftment criteria
Must not have
Acute GVHD of the gut or liver currently on systemic therapy
Unable to swallow capsule
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether fedratinib can help keep MPN from coming back after HCT.

Who is the study for?
Adults with myeloproliferative neoplasms who've had a stem cell transplant can join this trial. They should be in good physical condition, understand the study, and follow its schedule. Women of childbearing age must test negative for pregnancy and use effective birth control; men must also practice safe sex or abstinence.
What is being tested?
The trial is testing fedratinib pills as a maintenance therapy to prevent cancer from returning after a stem cell transplant. Participants will take the medication orally to see if it's effective and safe in maintaining their health post-transplant.
What are the potential side effects?
Fedratinib may cause side effects like nausea, vomiting, diarrhea, liver problems, low blood counts leading to increased infection risk or bleeding issues. There might also be neurological symptoms such as confusion or difficulty coordinating movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to care for myself and perform daily activities.
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I have a Philadelphia chromosome negative blood disorder and had a bone marrow transplant.
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I am using approved contraception methods.
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I am 18 years old or older.
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My condition has not worsened according to specific health criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently receiving treatment for acute GVHD affecting my gut or liver.
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I cannot swallow pills.
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I have been diagnosed with chronic liver disease.
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I am currently receiving treatment for another cancer.
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I am not taking medication that strongly activates CYP3A4.
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I have a condition that affects how my body absorbs pills.
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I have had Wernicke's encephalopathy in the past.
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I am experiencing symptoms related to brain function issues.
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I have not had major surgery in the last 28 days.
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I have been diagnosed with HIV, Hepatitis B, or Hepatitis C.
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I am currently fighting a serious infection.
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I have heart failure that is not well-managed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1: Recommended Phase 2 Dose
Phase 2: Progression Free Survival
Secondary study objectives
Number of Participants who develop Chronic Graft vs Host Disease
Overall Survival
Relapse Rate
+1 more

Awards & Highlights

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

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2: Treatment at Recommended Phase 2 Dose (RP2D)Experimental Treatment1 Intervention
Participants will take fedratinib at the dose determined in the phase 1 portion of this study, once daily by mouth.
Group II: Phase 1: Dose Level 3Experimental Treatment1 Intervention
Participants will take 400 mg fedratinib once daily by mouth.
Group III: Phase 1: Dose Level 2Experimental Treatment1 Intervention
Participants will take 300 mg fedratinib once daily by mouth.
Group IV: Phase 1: Dose Level 1Experimental Treatment1 Intervention
Participants will take 200 mg fedratinib once daily by mouth.

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
562 Previous Clinical Trials
144,836 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,129,557 Total Patients Enrolled
Hany Elmariah, MD, MSPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
56 Total Patients Enrolled

Media Library

Fedratinib Pill Clinical Trial Eligibility Overview. Trial Name: NCT05127174 — Phase 1 & 2
Myeloproliferative Neoplasms Research Study Groups: Phase 1: Dose Level 2, Phase 1: Dose Level 1, Phase 1: Dose Level 3, Phase 2: Treatment at Recommended Phase 2 Dose (RP2D)
Myeloproliferative Neoplasms Clinical Trial 2023: Fedratinib Pill Highlights & Side Effects. Trial Name: NCT05127174 — Phase 1 & 2
Fedratinib Pill 2023 Treatment Timeline for Medical Study. Trial Name: NCT05127174 — Phase 1 & 2
~2 spots leftby Aug 2025
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