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IDH Inhibitor

Fedratinib + IDH Inhibitors for Blood Cancers

Phase 1
Recruiting
Led By Olatoyosi Odenike, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Female patients of childbearing potential must have negative results for a pregnancy test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of combining three drugs to treat rare blood cancers.

Who is the study for?
Adults diagnosed with advanced-phase IDH-mutated Ph-negative myeloproliferative neoplasms (MPNs) who have not been treated with an IDH1/2 inhibitor or fedratinib, and are not on certain other treatments. Participants need to be in stable health otherwise, able to understand the study, and willing to use contraception. Pregnant women, those with heart issues like long QT syndrome without approval, active infections or second cancers (except non-melanoma skin cancer), and individuals with a history of brain disease or severe allergies related to the drugs are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of fedratinib (a jak inhibitor) with ivosidenib or enasidenib (anti-cancer drugs). These medications are approved separately for different conditions but haven't been approved together for treating rare blood cancers with IDH mutations. The study aims to determine their safety and effectiveness when used in combination.See study design
What are the potential side effects?
Potential side effects may include gastrointestinal symptoms such as nausea and vomiting, liver enzyme elevations indicating potential liver damage, risk of infection due to bone marrow suppression by these drugs, fatigue from anemia caused by bone marrow suppression, neurological issues like dizziness or confusion which could indicate brain-related side effects.

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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I am a woman who can have children and my pregnancy test is negative.
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I can take care of myself but might not be able to do heavy physical work.
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My kidney function is within the required range.
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My blood cancer is in an advanced stage with a specific mutation and has more than 5% blasts.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose of Fedratinib Combined with Enasidenib in Participants Who Have IDH2 Mutations
Maximum Tolerated Dose of Fedratinib Combined with Ivosidenib in Participants Who Have IDH1 Mutations
Secondary outcome measures
1-Year Overall Survival
Overall Response Rate (ORR)
Time to Response

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B - Participants with IDH2 MutationsExperimental Treatment2 Interventions
After genetic testing, if participants are found to have IDH2 Mutations (a genetic mutation) then they will be assigned to this group and will receive the following study drugs: Single agent Phase (Cycles 1-3): The initial phase of treatment will consist of 3 cycles (lasting 28 days) of enasidenib 100mg daily x 28 days Combination Phase (Cycle 4 onwards): If a participant shows clinical benefit (including their disease stabilizing) following the first 3- cycle phase, he or she may go onto the combination phase.Combination treatment will consist of enasidenib 100mg daily x 28 days along with fedratinib daily x 28 days.
Group II: Arm A - Participants with IDH1 MutationsExperimental Treatment2 Interventions
After genetic testing, if participants are found to have IDH1 Mutations (a genetic mutation) then they will be assigned to this group and will receive the following study drugs: Single agent Phase (Cycles 1-3): The initial phase of treatment will consist of 3 cycles (lasting 28 days) of ivosidenib 500mg daily x 28 days Combination Phase (Cycle 4 onwards): If a participant shows clinical benefit (including their disease stabilizing) following the first 3- cycle phase, he or she may go onto the combination phase. Combination treatment will consist of ivosidenib daily x 28 days along with fedratinib daily x 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ivosidenib
2019
Completed Phase 1
~20
Enasidenib
2020
Completed Phase 2
~560
Fedratinib
2019
Completed Phase 1
~190

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
997 Previous Clinical Trials
817,648 Total Patients Enrolled
Olatoyosi Odenike, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
44 Total Patients Enrolled

Media Library

Enasidenib (IDH Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04955938 — Phase 1
Isocitrate Dehydrogenase Research Study Groups: Arm B - Participants with IDH2 Mutations, Arm A - Participants with IDH1 Mutations
Isocitrate Dehydrogenase Clinical Trial 2023: Enasidenib Highlights & Side Effects. Trial Name: NCT04955938 — Phase 1
Enasidenib (IDH Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04955938 — Phase 1

Frequently Asked Questions

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

Has Fedratinib been given the go-ahead from the FDA?

"In the absence of substantial evidence regarding its safety and efficacy, Fedratinib received a score of 1."

Answered by AI

To what ailment is Fedratinib most regularly prescribed?

"Fedratinib has been primarily utilized to treat high-risk IPSS patients. It is also used therapeutically for leukemia, myelocytic and acute primary myelofibrosis as well as idh1 mutation susceptibilities."

Answered by AI

Is this trial setting a precedent for similar research?

"Research into Fedratinib began in 2013, and the first trial was conducted by Celgene. After 345 participants were studied, Phase 1 & 2 approval of the drug occurred and now there are 46 live trials for it across 255 cities around 45 nations."

Answered by AI

How many participants are included in this research endeavor?

"Affirmative. Online records on clinicaltrials.gov verify that this study is presently recruiting individuals, beginning with its initial posting in October 2021 and most recently edited in November of the same year. Fifty participants are needed at only one site for enrollment."

Answered by AI

Are there current opportunities for volunteers to participate in this research?

"As indicated by clinicaltrials.gov, this medical research is actively seeking participants. The study was first publicised on October 29th 2021 and has been amended as recently as November 12th 2021"

Answered by AI

What other experiments have been conducted with Fedratinib?

"Currently, Fedratinib is the subject of 46 distinct clinical trials. 5 of these are in their final phase 3 stage and 1523 locations across the world offer this treatment to patients. The majority of trial sites for Fedratinib are located in Edmonton, Alberta."

Answered by AI
~19 spots leftby Oct 2025