Fedratinib Pill for Neutrophilic Leukemia

Cleveland Clinic, Cleveland, OH
Neutrophilic Leukemia+2 More ConditionsFedratinib Pill - Drug
Eligibility
18+
All Sexes

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.

Eligible Conditions
  • Myeloproliferative Neoplasms
  • Chronic Neutrophilic Leukemia
  • Myelodysplastic Syndrome

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: at week 24

Up to 24 weeks
Objective Clinical Response Rate
at 12 weeks
Proportion of patients achieving spleen response at 12 weeks
Proportion of patients who have a 50% reduction in Myeloproliferative Neoplasm Symptom Assessment Form total symptom score (MPN-SAF TSS) at 12 weeks
at 24 weeks
Proportion of patients achieving spleen response at 24 weeks
Myeloproliferative disease
at week 12
Patient's global impression of change (PGIC) at week 12
at week 24
Patient's global impression of change (PGIC) at week 24

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Treatment with Fedratinib
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Fedratinib Pill · No Placebo Group · Phase 2

Treatment with Fedratinib
Drug
Experimental Group · 1 Intervention: Fedratinib Pill · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at week 24

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,542 Previous Clinical Trials
4,019,631 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
514 Previous Clinical Trials
128,251 Total Patients Enrolled
Andrew Kuykendall, MDPrincipal InvestigatorMoffitt Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.