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Fedratinib + IDH Inhibitors for Blood Cancers
Study Summary
This trial is testing the safety and effectiveness of combining three drugs to treat rare blood cancers.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: Arm B - Participants with IDH2 Mutations
- Group 2: Arm A - Participants with IDH1 Mutations
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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"
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."
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