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Enasidenib for Clonal Cytopenia
Study Summary
This trial is testing whether a drug called enasidenib can improve blood cell counts in people with clonal cytopenia of undetermined significance (CCUS).
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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- My spleen is overactive.I am able to get out of my bed or chair and move around.I have recently been treated for a solid tumor cancer.My liver, kidneys, and blood iron levels are functioning well.I have a stomach or intestine condition that affects how medicines work in my body.I do not have any ongoing, untreated infections.I have or had blood cancer.I have had low blood counts for over 6 months without a known cause.I am 18 years old or older.I have an active cancer that meets specific criteria.My cancer has a specific IDH2 gene mutation.
- Group 1: Participants with CCUS with mutations in IDH2
- 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 the FDA approved of Enasidenib's use?
"Practically no clinical data exists for Enasidenib's safety or efficacy, thus it has been assigned a score of 1."
Could you please summarize any preceding trials that have made use of Enasidenib?
"At this time, 24 clinical trials involving Enasidenib have commenced with 2 of these in Phase 3. Edmonton, Alberta is a major site for the research but 601 different sites are operating studies related to that drug."
Is this a groundbreaking research endeavor?
"Since 2013, scientists have been investigating enasidenib in clinical trials. Initially sponsored by Celgene and involving 345 patients, the drug was given Phase 1 & 2 approval following these studies. As of today, 24 active trials for Enasidenib can be found across 84 cities and 28 nations worldwide."
Are there any current opportunities to participate in this clinical trial?
"Affirmative. Data on clinicaltrials.gov attests to this medical study's call for participants, with the trial having been published on October 6th 2021 and revised as recently as April 18th 2022. This investigation is searching for 15 persons among 12 different locations."
What is the current sample size of this clinical experiment?
"Affirmative. As of April 18th 2022, the clinical trial is actively recruiting from 12 sites and looking to bring on 15 patients total. This medical research was initially posted on October 6th 2021 according to information hosted by clinicaltrials.gov."
How many locations are overseeing this clinical trial?
"This trial is recruiting from a dozen different locations, including Oregon Health & Science University (Data Collection Only) in Portland, Memorial Sloan Kettering Westchester (All Protocol Activities) in Harrison and Washington University (Data Collection and Specimen Analysis) in Saint Louis. Additional sites are also taking part."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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