A Phase 2 interventional study of Fedratinib Pill in Myeloproliferative Neoplasm, Chronic Neutrophilic Leukemia and MDS, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 2, Interventional, and Treatment
The purpose of the study is to evaluate the effectiveness, safety, and tolerability of a study drug called fedratinib in participants with myelodysplastic/myeloproliferative neoplasms (MDS/MPNs) and chronic neutrophilic leukemia (CNL).
626 studies on the registry are indexed under Myeloproliferative Disorders; 109 are open to participants now.
This study's enrollment of 25 is below the median of 45 across 439 interventional studies indexed under Myeloproliferative Disorders.
Browse Myeloproliferative Disorders studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Morphologically confirmed diagnosis of one of the following in accordance with WHO (2016) diagnostic criteria:
Exclusion Criteria:
Patient with known human immunodeficiency virus (HIV), active infectious Hepatitis B (Hep B), and/or active Hepatitis C (Hep C).
a. Patients with known HIV are eligible if the following criteria are met: i. Patient has CD4+ T-cell count ≥ 350 cells/µL ii. Patient is on established anti-retroviral therapy (ART) (with medications that are not specifically excluded due to potential interactions within this study) for at least four weeks prior to study enrollment and have an HIV viral load less than 400 copies/mL prior to enrollment.
b. Patients with a history of Hep C infection are eligible if: i. Patient has completed curative antiviral treatment and has hepatitis C viral load below the limit of quantification ii. Pt has Hep C antibody positive but Hep C RNA negative due to prior treatment or natural resolution.
Participants will taken Fedratinib by mouth once a day every day of each 28 day cycle.
Drug: Fedratinib Pill
Participants will be given Fedratinib at a dose of 400 mg PO once daily (4-100 mg capsules). Fedratinib can be given at any time during the day, but patients are advised to take the dose at the same approximate time every day.
Also known as: Inrebic
Objective Clinical Response Rate
Response rate of fedratinib in MDS/MPN and CNL. Investigators will measure the proportion of patients achieving a clinical response from baseline to week 24 as defined by Complete Response (CR), Partial Response (PR) or Clinical Benefit (CB) by modified MDS/MPN IWG Proposed response criteria.
Time frame: Up to 24 weeks
Proportion of Patients Achieving Spleen Response at 12 Weeks
Participants spleen size will be measured and compared to baseline spleen size measurement. Spleen response is defined as 50% reduction in palpable splenomegaly of a spleen that is at least 10cm at baseline, a spleen that is palpable at more than 5 cm at baseline becoming non-palpable, or, in cases where volumetric evaluation is feasible, a ≥ 35% reduction in spleen volume in patients with a baseline spleen volume \> 450 cc. Spleen responses by palpation will need to correlate with a 50% reduction in longest diameter of the spleen by imaging.
Time frame: at 12 weeks
Proportion of Patients Achieving Spleen Response at 24 Weeks
Participants spleen size will be measured and compared to baseline spleen size measurement. Spleen response is defined as 50% reduction in palpable splenomegaly of a spleen that is at least 10cm at baseline, a spleen that is palpable at more than 5 cm at baseline becoming non-palpable, or, in cases where volumetric evaluation is feasible, a ≥ 35% reduction in spleen volume in patients with a baseline spleen volume \> 450 cc. Spleen responses by palpation will need to correlate with a 50% reduction in longest diameter of the spleen by imaging.
Time frame: at 24 weeks
Proportion of Patients Who Have a 50% Reduction in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) at 12 Weeks
Reduction in MPN-SAF TSS score will be measured by comparing TSS score at day 84 assessment to TSS score on cycle 1 day 1. Only patients with baseline TSS ≥ 10 will be eligible for symptom response. Patients who do not have a TSS score performed at day 84 assessment or who have discontinued study drug prior to day 84 assessment will be considered to not have 50% reduction in TSS. The MPN-SAF TSS is a questionnaire with nine items containing the most common symptoms reported by patients (concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss and fever), plus one item ("worst fatigue") from the "Brief Fatigue Inventory (BFI)". Each item has a score that ranges from 0 (absent/as good as it can be) to 10 (worst imaginable/as bad as it can be). A higher score therefore indicates more severe symptoms
Time frame: at 12 weeks
Proportion of Patients Who Have a 50% Reduction in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) at 24 Weeks
Reduction in MPN-SAF TSS score will be measured by comparing TSS score at day 84 assessment to TSS score on cycle 1 day 1. Only patients with baseline TSS ≥ 10 will be eligible for symptom response. Patients who do not have a TSS score performed at day 84 assessment or who have discontinued study drug prior to day 84 assessment will be considered to not have 50% reduction in TSS. The MPN-SAF TSS is a questionnaire with nine items containing the most common symptoms reported by patients (concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss and fever), plus one item ("worst fatigue") from the "Brief Fatigue Inventory (BFI)". Each item has a score that ranges from 0 (absent/as good as it can be) to 10 (worst imaginable/as bad as it can be). A higher score therefore indicates more severe symptoms
Time frame: at 24 weeks
Patient's Global Impression of Change (PGIC) at Week 12
Patient's global impression of change will be measured using the validated questionnaire wherein patients are asked about the change in their myelofibrosis symptoms since starting on the study. Patients can choose from one of seven potential answers: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. This will be reportedly qualitatively wherein the number of patients choosing particular answers will be tabulated and frequencies will be reported.
Time frame: at week 12
Patient's Global Impression of Change (PGIC) at Week 24
Patient's global impression of change will be measured using the validated questionnaire wherein patients are asked about the change in their myelofibrosis symptoms since starting on the study. Patients can choose from one of seven potential answers: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. This will be reportedly qualitatively wherein the number of patients choosing particular answers will be tabulated and frequencies will be reported.
Time frame: at week 24
| Milestone | Treatment With Fedratinib |
|---|---|
| Started | 25 |
| Completed | 25 |
| Not completed | 0 |
Response rate of fedratinib in MDS/MPN and CNL. Investigators will measure the proportion of patients achieving a clinical response from baseline to week 24 as defined by Complete Response (CR), Partial Response (PR) or Clinical Benefit (CB) by modified MDS/MPN IWG Proposed response criteria.
| percentage of participants | Treatment With Fedratinib |
|---|---|
| Objective Clinical Response Rate | 44 |
Participants spleen size will be measured and compared to baseline spleen size measurement. Spleen response is defined as 50% reduction in palpable splenomegaly of a spleen that is at least 10cm at baseline, a spleen that is palpable at more than 5 cm at baseline becoming non-palpable, or, in cases where volumetric evaluation is feasible, a ≥ 35% reduction in spleen volume in patients with a baseline spleen volume \> 450 cc. Spleen responses by palpation will need to correlate with a 50% reduction in longest diameter of the spleen by imaging.
| percentage of participants | Treatment With Fedratinib |
|---|---|
| Proportion of Patients Achieving Spleen Response at 12 Weeks | 35 |
Participants spleen size will be measured and compared to baseline spleen size measurement. Spleen response is defined as 50% reduction in palpable splenomegaly of a spleen that is at least 10cm at baseline, a spleen that is palpable at more than 5 cm at baseline becoming non-palpable, or, in cases where volumetric evaluation is feasible, a ≥ 35% reduction in spleen volume in patients with a baseline spleen volume \> 450 cc. Spleen responses by palpation will need to correlate with a 50% reduction in longest diameter of the spleen by imaging.
| percentage of participants | Treatment With Fedratinib |
|---|---|
| Proportion of Patients Achieving Spleen Response at 24 Weeks | 30 |
Reduction in MPN-SAF TSS score will be measured by comparing TSS score at day 84 assessment to TSS score on cycle 1 day 1. Only patients with baseline TSS ≥ 10 will be eligible for symptom response. Patients who do not have a TSS score performed at day 84 assessment or who have discontinued study drug prior to day 84 assessment will be considered to not have 50% reduction in TSS. The MPN-SAF TSS is a questionnaire with nine items containing the most common symptoms reported by patients (concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss and fever), plus one item ("worst fatigue") from the "Brief Fatigue Inventory (BFI)". Each item has a score that ranges from 0 (absent/as good as it can be) to 10 (worst imaginable/as bad as it can be). A higher score therefore indicates more severe symptoms
| percentage of participants | Treatment With Fedratinib |
|---|---|
| Proportion of Patients Who Have a 50% Reduction in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) at 12 Weeks | 45 |
Reduction in MPN-SAF TSS score will be measured by comparing TSS score at day 84 assessment to TSS score on cycle 1 day 1. Only patients with baseline TSS ≥ 10 will be eligible for symptom response. Patients who do not have a TSS score performed at day 84 assessment or who have discontinued study drug prior to day 84 assessment will be considered to not have 50% reduction in TSS. The MPN-SAF TSS is a questionnaire with nine items containing the most common symptoms reported by patients (concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss and fever), plus one item ("worst fatigue") from the "Brief Fatigue Inventory (BFI)". Each item has a score that ranges from 0 (absent/as good as it can be) to 10 (worst imaginable/as bad as it can be). A higher score therefore indicates more severe symptoms
| percentage of participants | Treatment With Fedratinib |
|---|---|
| Proportion of Patients Who Have a 50% Reduction in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) at 24 Weeks | 47 |
Patient's global impression of change will be measured using the validated questionnaire wherein patients are asked about the change in their myelofibrosis symptoms since starting on the study. Patients can choose from one of seven potential answers: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. This will be reportedly qualitatively wherein the number of patients choosing particular answers will be tabulated and frequencies will be reported.
Results for this outcome have not been posted.
Patient's global impression of change will be measured using the validated questionnaire wherein patients are asked about the change in their myelofibrosis symptoms since starting on the study. Patients can choose from one of seven potential answers: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. This will be reportedly qualitatively wherein the number of patients choosing particular answers will be tabulated and frequencies will be reported.
Results for this outcome have not been posted.
Collected over Up to 36 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment With Fedratinib | 11/25 (44%) | 13/25 (52%) | 25/25 (100%) |
| Event | Treatment With Fedratinib |
|---|---|
| Rectal hemorrhageGastrointestinal disorders | 3/25 |
| ColitisGastrointestinal disorders | 2/25 |
| Edema limbsGeneral disorders | 2/25 |
| Lung infectionInfections and infestations | 2/25 |
| Back painMusculoskeletal and connective tissue disorders | 2/25 |
| Acute kidney injuryRenal and urinary disorders | 2/25 |
| Cardiac disorders - Other, specifyCardiac disorders | 1/25 |
| Heart failureCardiac disorders | 1/25 |
| Anal fistulaGastrointestinal disorders | 1/25 |
| DiarrheaGastrointestinal disorders | 1/25 |
| Event | Treatment With Fedratinib |
|---|---|
| ConstipationGastrointestinal disorders | 12/25 |
| Lipase increasedInfections and infestations | 12/25 |
| DiarrheaGastrointestinal disorders | 11/25 |
| FatigueGeneral disorders | 10/25 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 10/25 |
| Abdominal painGastrointestinal disorders | 9/25 |
| NauseaGastrointestinal disorders | 9/25 |
| Creatinine increasedInfections and infestations | 9/25 |
| Muscle crampMusculoskeletal and connective tissue disorders | 9/25 |
| AnemiaBlood and lymphatic system disorders | 9/25 |
| Age, Customized(Participants) | Treatment With Fedratinib |
|---|---|
| 30-39 | 1 |
| 40-49 | 2 |
| 50-59 | 3 |
| 60-69 | 8 |
| 70-79 | 9 |
| 80-89 | 2 |
| Sex: Female, Male(Participants) | Treatment With Fedratinib |
|---|---|
| Female | 11 |
| Male | 14 |
| Ethnicity (NIH/OMB)(Participants) | Treatment With Fedratinib |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 24 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment With Fedratinib |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 15 |
| More than one race | 4 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Treatment With Fedratinib |
|---|---|
| United States | 25 |
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H. Lee Moffitt Cancer Center and Research Institute