Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Myeloproliferative Disorders

Leukemia, Neutrophilic, Chronic

Myelodysplastic-Myeloproliferative Diseases

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Chronic Neutrophilic Leukemia

Participants will taken Fedratinib by mouth once a day every day of each 28 day cycle.

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.

Fedratinib Pill

Quan Lovette

Andrew Kuykendall, MD

Onyee Chan, MD

Timothy E Kubal, MD, MBA

Jeffrey E Lancet, MD

Eric Padron, MD

David A Sallman, MD

Kendra L Sweet, MD

Keniya Chambers

Kristen Pettit, MD

Kaylie Sunyak

Abhay Singh, MD

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).

Fedratinib in Myelodysplastic /Myeloproliferative Neoplasms (MDS/MPNs) and Chronic Neutrophilic Leukemia (CNL)

A Phase 2 Study of Fedratinib in Myelodysplastic /Myeloproliferative Neoplasms (MDS/MPNs) and Chronic Neutrophilic Leukemia (CNL)

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.

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.

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.

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

Bristol-Myers Squibb

H. Lee Moffitt Cancer Center and Research Institute

Amino Acids

All Drugs and Chemicals

Tyrosine

Participants will take 200 mg fedratinib once daily by mouth.

Participants will take 300 mg fedratinib once daily by mouth.

Participants will take 400 mg fedratinib once daily by mouth.

Participants will take fedratinib at the dose determined in the phase 1 portion of this study, once daily by mouth.

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).

Maria Urdiales

Hany Elmariah, MD, MS

Nelli Bejanyan, MD

Rawan G Faramand, MD

Farhad Khimani, MD

Andrew T Kuykendall, MD

Hien D Liu, MD

Asmita Mishra, MD

Michael L Nieder, MD

Taiga Nishihori, MD

Lia E Perez, MD

Joseph A Pidala, MD, PhD

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).

Maintenance Fedratinib to Prevent Post-Transplant Relapse in Myeloproliferative Neoplasms

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

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%.

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

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

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.

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

Rate of deaths related to Hematopoietic Cell Transplant.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fedratinib in Myelodysplastic /Myeloproliferative Neoplasms (MDS/MPNs) and Chronic Neutrophilic Leukemia (CNL)	NCT05177211	Myeloproliferat... Chronic Neutrop... MDS	Fedratinib Pill	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Maintenance Fedratinib to Prevent Post-Transplant Relapse in Myeloproliferative Neoplasms	NCT05127174	Myeloproliferat...	Fedratinib Pill	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

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