Fedratinib for Myeloproliferative Disorders

Overseen By Maria Urdiales

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: JAK2 inhibitors, Chemotherapy

Disqualifiers: Acute GVHD, Wernicke's encephalopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

Trial Summary

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).

Research Team

Taiga Nishihori, MD

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Phase 2: Treatment at Recommended Phase 2 Dose (RP2D) Experimental Treatment 1 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 3 Experimental Treatment 1 Intervention

Participants will take 400 mg fedratinib once daily by mouth.

Group III: Phase 1: Dose Level 2 Experimental Treatment 1 Intervention

Participants will take 300 mg fedratinib once daily by mouth.

Group IV: Phase 1: Dose Level 1 Experimental Treatment 1 Intervention

Participants will take 200 mg fedratinib once daily by mouth.

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

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

Bristol-Myers Squibb

Chief Medical Officer since 2024

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