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Myeloproliferative NeoplasmPhase 1NCT05127174

Maintenance Fedratinib to Prevent Post-Transplant Relapse in Myeloproliferative Neoplasms

A Phase 1 study testing Fedratinib Pill in people with Myeloproliferative Neoplasm, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloproliferative Neoplasm
What is being tested?
Fedratinib Pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
14 Mar 2022to 3 Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 18 years of age at the time of signing the informed consent form (ICF)
  • Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of 0, 1 or 2
  • Must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  • Willing and able to adhere to the study visit schedule and other protocol requirements.
  • Philadelphia chromosome negative myeloproliferative disease (including polycythemia vera, myelofibrosis, and essential thrombocytosis, chronic myelomonocytic leukemia, atypical chronic myelogenous leukemia, myelodysplastic syndrome/myeloproliferative neoplasm-unclassified, MPN not otherwise specified) having undergone first allogeneic HCT.
  • Engraftment including >95% myeloid cell donor chimerism and Absolute neutrophil count (ANC) > 1.0 x 109/L
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  • Platelets > 50 x 109/L with no platelet transfusions in the prior 7 days
  • Absence of disease progression as defined by International Working Group (IWG) Myeloproliferative Neoplasm Response Criteria
  • Acute GVHD of the skin is permitted if prednisone has been tapered to <0.25 mg/kg with continued response
  • Females of childbearing potential (FCBP) must:
  • 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.
  • Note: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Male participants must:
  • Practice true abstinence (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 30 days following investigational product discontinuation, or longer if required for each compound and/or by local regulations, even if he has undergone a successful vasectomy.
  • True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
  • Agreement to use highly effective methods of contraception that alone or in combination resulting in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly throughout the course of the study. Such methods include: Combined (estrogen and progestogen containing) hormonal contraception: Oral; Intravaginal; Transdermal; Progestogen-only hormonal contraception associated with inhibition of ovulation: Oral; Injectable hormonal contraception; Implantable hormonal contraception; Placement of an intrauterine device; Placement of an intrauterine hormone-releasing system; Bilateral tubal occlusion; Vasectomized partner.

Who cannot join

  • Acute GVHD of the gut or liver currently on systemic therapy. Patients who have completed systemic therapy and are asymptomatic may be enrolled.
  • Treatment with JAK2 inhibitor within 14 days prior to enrollment.
  • Any of the laboratory abnormalities outlined in protocol
  • Pregnant or lactating female
  • Prior history of Wernicke's encephalopathy (WE)
  • Has signs or symptoms of encephalopathy, including Wernicke's Encephalopathy (e.g. severe ataxia, ocular paralysis or cerebellar signs) in which case thiamine deficiency needs to be excluded and a brain MRI might be required to exclude possible Wernicke's encephalopathy
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  • Patient with concomitant treatment with or use of pharmaceutical or herbal agents known to be strong inducers of CYP3A4. However, if a patient is started on a strong CYP3A4 inducer while on fedratinib, the dose must be adjusted as described in the drug-drug interaction section below.
  • Thiamine levels below the normal range, per institutional standard, may enroll but must be corrected to the normal range before initiating treatment with fedratinib (See section 6.5.1). Normalized thiamine level must be confirmed within 10 days of starting fedratinib therapy.
  • On any chemotherapy, immunomodulatory drug therapy (e.g., thalidomide, interferon-alpha), Anagrelide, or concurrent JAK2 inhibitor. Patients who have had exposure to hydroxyurea (e.g., hydrea) in the past may be enrolled into the study as long as it has not been administered within 14 days prior to initiation of fedratinib
  • On treatment with myeloid growth (e.g. G-CSF) factor within 14 days prior to initiation of fedratinib
  • On treatment with aspirin with doses > 150 mg daily
  • Major surgery within 28 days before starting fedratinib
  • Diagnosis of chronic liver disease (e.g., chronic alcoholic liver disease, autoimmune hepatitis, sclerosing cholangitis, primary biliary cirrhosis, hemochromatosis, non-alcoholic steatohepatitis
  • Uncontrolled congestive heart failure (New York Heart Association Classification 3 or 4)
  • Known human immunodeficiency virus (HIV), evidence of active infectious Hepatitis B (Hep B), and/or evidence of active Hepatitis C (Hep C)
  • Serious active infection
  • Presence of any significant gastric or other disorder that would inhibit absorption of oral medication
  • Concurrent active malignancy requiring therapy. Localized skin basal cell or squamous cell carcinomas are permitted.
  • Bone marrow blast percentage greater than 10%.
  • Unable to swallow capsule

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase I/II Trial of Maintenance Fedratinib to Prevent Post-Transplant Relapse in Myeloproliferative Neoplasms

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).

Being tested
Fedratinib Pill
Keywords
allogeneic hematopoietic cell transplant (HCT)
Medical subject headings
Myeloproliferative Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fedratinib PillDrug

    Also called Inrebic

    Fedratinib is taken orally once per day, in 100 mg capsules. Fedratinib is an oral kinase inhibitor with activity against wild type and mutationally activated Janus Associated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3).

Study groups in NCT05127174
Study groupRoleWhat they receive
Phase 1: Dose Level 1ExperimentalParticipants will take 200 mg fedratinib once daily by mouth.
Receives: Drug: Fedratinib Pill
Phase 1: Dose Level 2ExperimentalParticipants will take 300 mg fedratinib once daily by mouth.
Receives: Drug: Fedratinib Pill
Phase 1: Dose Level 3ExperimentalParticipants will take 400 mg fedratinib once daily by mouth.
Receives: Drug: Fedratinib Pill
Phase 2: Treatment at Recommended Phase 2 Dose (RP2D)ExperimentalParticipants will take fedratinib at the dose determined in the phase 1 portion of this study, once daily by mouth.
Receives: Drug: Fedratinib Pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Recommended Phase 2 Dose

    Participants will be treated at increasing dose levels to determine the Recommended Phase 2 Dose (RP2D). The RP2D will be defined as the highest dose level with a true dose limiting toxicity (DLT) rate <33%.

    Measured: Up to 1 year

  2. Phase 2: Progression Free Survival

    Progression Free Survival defined as the time from start of treatment to the time of disease progression or death.

    Measured: at 1 year

Secondary outcomes (4)

  1. Number of Participants who develop Chronic Graft vs Host Disease

    Number of Participants who develop Chronic Graft vs Host Disease (GVHD)

    Measured: 1 year

  2. Overall Survival

    Overall Survival (OS) is defined as the time from the date of HCT (Hematopoietic Cell Transplant) to the date of death due to any cause.

    Measured: 1 year

  3. Relapse Rate

    Disease relapse rate, defined as the incidence of signs of symptoms of disease returning after a period of improvement.

    Measured: 1 year

  4. Transplant related mortality rate

    Rate of deaths related to Hematopoietic Cell Transplant.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2021
  2. Study start14 Mar 2022
  3. Primary completion3 Jan 2025
  4. Study completion3 Jan 2025

Why it stopped: Did not advance to Phase 2

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05127174
Sponsor's protocol ID
MCC-20923
Other IDs
FEDR-CL-MF-PI-13906
Status last verified
Dec 2025
First submitted
9 Nov 2021
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fedratinib Pill in people with Myeloproliferative Neoplasm, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Did not advance to Phase 2). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Recommended Phase 2 Dose (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05127174.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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