12 Participants Needed

Fedratinib for Myeloproliferative Disorders

MU
Overseen ByMaria Urdiales
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Taiga Nishihori | Moffitt

Taiga Nishihori, MD

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have skin GVHD but am responding to a low dose of prednisone.
I am able to care for myself and perform daily activities.
I have a Philadelphia chromosome negative blood disorder and had a bone marrow transplant.
See 5 more

Exclusion Criteria

I have been diagnosed with chronic liver disease.
I am currently receiving treatment for acute GVHD affecting my gut or liver.
Thiamine levels below the normal range
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive fedratinib at varying doses to determine the Recommended Phase 2 Dose (RP2D)

Up to 1 year

Treatment Phase 2

Participants receive fedratinib at the RP2D determined in Phase 1

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Fedratinib
Trial Overview 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Phase 2: Treatment at Recommended Phase 2 Dose (RP2D)Experimental Treatment1 Intervention
Group II: Phase 1: Dose Level 3Experimental Treatment1 Intervention
Group III: Phase 1: Dose Level 2Experimental Treatment1 Intervention
Group IV: Phase 1: Dose Level 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

Bristol-Myers Squibb

Industry Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

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