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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
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
1,016 Previous Clinical Trials
734,209 Total Patients Enrolled
Olatoyosi Odenike, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
44 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I am currently taking hydroxyurea or steroids to manage my condition.I have been treated with an IDH1, IDH2 inhibitor, or fedratinib.I have had progressive multifocal leukoencephalopathy in the past.I am a woman who can have children and my pregnancy test is negative.I have another active cancer besides non-melanoma skin cancer.I am allergic to medications similar to fedratinib, ivosidenib, or enasidenib.I can take care of myself but might not be able to do heavy physical work.My kidney function is within the required range.I have a condition that affects how I absorb pills.My heart's electrical activity (QTc interval) is normal or I don't have risk factors for irregular heartbeat.I do not have any uncontrolled illnesses.I am not receiving any cancer treatments not listed in this study's protocol.I have had a brain disorder like Wernicke's encephalopathy before.It's been over 2 weeks since my last major surgery, radiation, or trial participation.My blood cancer is in an advanced stage with a specific mutation and has more than 5% blasts.I am HIV-positive or have active hepatitis B/C and am on antiretroviral therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B - Participants with IDH2 Mutations
- Group 2: Arm A - Participants with IDH1 Mutations
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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