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JAK2 Inhibitor

Fedratinib for Leukemia

Phase 2
Recruiting
Led By Andrew Kuykendall, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be 18 years of age or older on the day of signing informed consent
Patient must have palpable splenomegaly ≥ 5 cm below left costal margin (LCM), spleen volume ≥ 450 cc, AND/OR MPN-SAF TSS > 10
Must not have
Patient on treatment with aspirin with doses > 150 mg daily
Patient with active second malignancies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 24
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug for people with myelodysplastic/myeloproliferative neoplasms or chronic neutrophilic leukemia. They want to see if it's effective, safe, and tolerated.

Who is the study for?
Adults with certain blood disorders like MDS/MPNs or CNL, who can swallow pills and have not been treated with fedratinib before. They must understand the study and agree to use effective contraception. Excluded are those with thiamine deficiency, serious infections, on specific drugs that affect fedratinib, pregnant women, or those with other major health issues.
What is being tested?
The trial is testing the effectiveness of a pill called fedratinib for treating blood disorders such as MDS/MPNs and CNL. It aims to see how safe it is for patients and if there are any side effects when taking this medication.
What are the potential side effects?
While not specified in the provided information, common side effects of similar medications may include nausea, vomiting, diarrhea, liver problems, low blood counts leading to increased infection risk or bleeding complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My spleen is enlarged and/or my blood disorder symptoms are severe.
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I have been diagnosed with a specific type of blood cancer that is not BCR-ABL1 positive.
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I can take care of myself but may not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking more than 150 mg of aspirin daily.
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I have another active cancer besides the one being treated.
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I cannot swallow capsules.
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I am not currently on chemotherapy, specific immune drugs, high-dose steroids, or have taken fedratinib.
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I have been diagnosed with chronic liver disease.
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I have a stomach condition that affects how I absorb pills.
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I have had encephalopathy or Wernicke's Encephalopathy before.
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I am not taking any drugs or herbs that strongly affect liver enzymes.
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I am currently receiving IV antibiotics for a serious infection.
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I have heart failure that is not well-managed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Clinical Response Rate
Secondary study objectives
Proportion of patients achieving spleen response at 12 weeks
Proportion of patients achieving spleen response 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
+1 more
Other study objectives
Patient's global impression of change (PGIC) at week 12
Patient's global impression of change (PGIC) at week 24

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment with FedratinibExperimental Treatment1 Intervention
Participants will taken Fedratinib by mouth once a day every day of each 28 day cycle.

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
561 Previous Clinical Trials
144,804 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,682 Previous Clinical Trials
4,124,996 Total Patients Enrolled
Andrew Kuykendall, MDPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
34 Total Patients Enrolled

Media Library

Fedratinib (JAK2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05177211 — Phase 2
Neutrophilic Leukemia Research Study Groups: Treatment with Fedratinib
Neutrophilic Leukemia Clinical Trial 2023: Fedratinib Highlights & Side Effects. Trial Name: NCT05177211 — Phase 2
Fedratinib (JAK2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05177211 — Phase 2
~0 spots leftby Dec 2024
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