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Enasidenib for Acute Myeloid Leukemia
Study Summary
This trial is testing whether enasidenib can help treat patients with IDH2-mutant leukemia who are undergoing hematopoietic stem cell transplantation.
- Acute Myeloid Leukemia
- Chronic Myelomonocytic Leukemia
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 1 & 2 trial • 21 Patients • NCT02273739Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
How many participants are involved in this research effort?
"Unfortunately, this clinical trial has suspended the recruitment of participants. It was first posted on July 17th 2018 and last updated on August 8th 2022. If you are seeking alternative medical studies related to cancer, there is a current pool of 3835 trials actively recruiting patients with cancer, as well as 24 Enasidenib-specific studies taking onboard new members."
Is this clinical endeavor the inaugural iteration of its type?
"Enasidenib has been studied since 2013, when the drug was first sponsored by Celgene and scrutinized in a trial involving 345 participants. After being approved for Phase 1 & 2 trials, 24 distinct clinical studies are now taking place across 84 cities and 28 countries."
What is the primary purpose of this clinical experiment?
"The primary outcome of this 28-day trial is to determine the Maximum Tolerable Dose (MTD). The number and severity of Enasidenib-related adverse events will be monitored based on Common Terminology Criteria for Adverse Events (CTCAE 4) standards. Additionally, researchers are looking into cumulative incidence of chronic GVHD, which is graded from mild to severe using an aggregate score system featuring 0 for no symptoms and 3 as the most serious signs. Lastly, a summary of mutations in the Isocitrate dehydrogenase gene via next-generation sequencing will also be evaluated."
Has the FDA sanctioned Enasidenib for medicinal use?
"Due to the fact that this is a first phase trial, with limited evidence in support of efficacy and safety, Enasidenib was given a score of 1."
Are there any openings remaining for participants of this clinical trial?
"Unfortunately, the clinical trial listed on clinicaltrials.gov is not presently recruiting candidates; although it was last updated as recently as August 8th 2022. However, 3859 other studies are currently welcoming participants."
Has Enasidenib been the focus of any other research initiatives?
"Currently, 24 separate clinical trials focusing on Enasidenib are in progress. Of those studies, two have already reached Phase 3 testing. While Edmonton is a common site for these experimentations, there are over 600 other locations worldwide offering access to this medication trial."
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