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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 24

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 24

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Clinical Response Rate

Secondary outcome measures

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 outcome measures

Patient's global impression of change (PGIC) at week 12

Patient's global impression of change (PGIC) at week 24

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,457 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,640 Previous Clinical Trials

4,129,439 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

Myelodysplastic Syndrome Research Study Groups: Treatment with Fedratinib

Myelodysplastic Syndrome 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other ongoing trials that are testing fedratinib?

"There are a total of 9 clinical trials underway that focus on Fedratinib Pill. 2 of those studies have progressed to Phase 3. Even though most research is based in Hackensack, New jersey, there are actually 284 trial locations across the globe."

Answered by AI

What are the potential side effects of Fedratinib?

"While Phase 2 trials don't provide efficacy data, Fedratinib Pill's safety was supported enough to give it a score of 2."

Answered by AI

What is the usual indication for Fedratinib?

"Fedratinib Pill can help patients in intermediate-2 ipss risk categories, high ipss risk categories, and those suffering from secondary myelofibrosis."

Answered by AI

How many people are currently involved in this research project?

"The information available on clinicaltrials.gov suggests that this research is still recruiting patients. The trial was first posted on March 1st, 2022 and the most recent update was on November 1st, 2022. They are hoping to enroll 25 individuals at a single site."

Answered by AI

Are there any current openings for subjects in this experiment?

"That is accurate, the clinical trial indicated on clinicaltrials.gov is actively recruiting patients. The listing was first posted on March 1st, 2022 and was last updated on November 1st, 2022. They are looking for a total of 25 individuals to participate across one location."

Answered by AI

Have there been any other similar clinical trials to this one in the past?

"Nine clinical trials using the Fedratinib Pill are ongoing in 20 countries and 49 cities. The first trial was completed in 2019 by Impact Biomedicines, Inc., a subsidiary of Celgene Corporation. This Phase 3 drug approval process included 38 patients. Since then, 15 more trials have been carried out."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Fedratinib in Myelodysplastic /Myeloproliferative Neoplasms (MDS/MPNs) and Chronic Neutrophilic Leukemia (CNL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05177211.

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