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Asciminib Combinations for Chronic Myeloid Leukemia (ALERTCML Trial)
ALERTCML Trial Summary
This trial is testing a new leukemia drug, and whether adding another drug may help patients who don't respond well to the first drug.
ALERTCML Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowALERTCML Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ALERTCML Trial Design
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Who is running the clinical trial?
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- I have had a stem cell transplant from a donor.My CML is in the accelerated or blast phase.I have been treated with asciminib before.I agree to use effective contraception or practice true abstinence during and up to 90 days after the study.I have had pancreatitis in the last year.I am not taking any strong medication that affects liver enzymes.I am currently being treated for another type of cancer.I've had limited CML treatment with a TKI for 30 days or less.I have had serious heart issues or abnormal heart rhythms in the past 6 months.I am a woman who cannot become pregnant or agrees to use two forms of birth control.I am 18 years old or older.I can take care of myself and perform daily activities.I was diagnosed with chronic phase CML less than 6 months ago and have specific genetic variants.I have an active hepatitis B infection.
- Group 1: Asciminib
- 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
Are there any US-based medical facilities implementing this investigation?
"This research project is recruiting participants at several different medical establishments, such as the Roswell Park Comprehensive Cancer Center in Buffalo, the Froedtert Hospital & The Medical College of Wisconsin in Milwaukee, and Georgia Cancer Center at Augusta University in Augusta."
Has Asciminib received the necessary authorization from the FDA?
"The safety of Asciminib was evaluated as a 2, since it falls under Phase 2 clinical trials and has yet to demonstrate efficacy in humans."
What is the aggregate of individuals taking part in this experiment?
"This clinical trial requires a total of 8 participants that match the predetermined eligibility criteria. These individuals can join this medical study at sites like Roswell Park Comprehensive Cancer Center in Buffalo, New york and Froedtert Hospital & the Medical College of Wisconsin located in Milwaukee, Georgia."
Has this trial ever been conducted prior to its current iteration?
"As of today, 44 clinical trials are underway to evaluate the efficacy of asciminib. These research projects span 587 cities and 47 nations. Novartis Pharmaceuticals conducted the initial trial in 2008 with 34 participants; since then, 82 experiments have been concluded successfully."
What prior inquiries have been conducted regarding Asciminib?
"Novartis Investigative Site first initiated research on asciminib in 2008 and has since completed 82 studies. There are 44 ongoing trials, with a substantial amount located in Buffalo, New york."
Are there any openings for volunteers in this experiment?
"Affirmative. Clinicaltrials.gov hosts information which affirms that this clinical trial, first posted on April 22nd 2022, is actively enrolling subjects. Notably, 8 patients need to be recruited from 4 separate medical centres."
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