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Fedratinib for Myeloproliferative Disorders

Phase 1 & 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: Recommended Phase 2 Dose

Phase 2: Progression Free Survival

Secondary outcome measures

Number of Participants who develop Chronic Graft vs Host Disease

Overall Survival

Relapse Rate

+1 more

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,449 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,640 Previous Clinical Trials

4,129,418 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities presently available for this clinical trial?

"Clinicaltrials.gov confirms that this trial is actively soliciting participants, with the initial posting on March 14th and a subsequent edit occurring November 28th of 2022."

Answered by AI

What objectives are scientists attempting to accomplish with this experiment?

"The main objective of this medical experiment, slated to last a maximum of one year, is to determine the Phase 2 Progression Free Survival rate. Other metrics that will be evaluated include: Number of Participants developing Chronic Graft vs Host Disease (GVHD), Transplant related mortality rate, and Overall Survival from Hematopoietic Cell Transplantation."

Answered by AI

Is this a groundbreaking medical experiment?

"Impact Biomedicines, Inc., a subsidiary of Celgene Corporation, initiated clinical trials for Fedratinib Pill in 2019. After 38 patients were evaluated during the first trial phase that year, Phase 3 drug approval was granted and 9 active studies are now underway across 49 cities and 20 nations."

Answered by AI

What is the aggregate size of this medical research's subjects?

"Affirmative, the clinical trial data on clinicaltrials.gov confirms that this study is actively seeking recruits. It was first posted in March 14th 2022, and has been recently updated on November 28th 2022. This research requires 46 individuals to be sourced from 1 location."

Answered by AI

What other experiments have been performed to gauge the efficacy of Fedratinib Pill?

"So far, 2 Phase 3 trials are in progress for the drug Fedratinib Pill. Compared to other studies within this field, 285 locations are conducting investigations on its efficacy with most of those sites being located in Chicago, Illinois."

Answered by AI

What medical maladies does the Fedratinib Pill typically address?

"Fedratinib Pill is suitable for patients with an intermediate-2 risk according to the IPSS scoring system, those considered high risk by this metric, and individuals suffering from secondary myelofibrosis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Maintenance Fedratinib to Prevent Post-Transplant Relapse in Myeloproliferative Neoplasms

2022. "Maintenance Fedratinib to Prevent Post-Transplant Relapse in Myeloproliferative Neoplasms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05127174.

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