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Asciminib for Chronic Myeloid Leukemia
Study Summary
This trial is studying ABL001 as a possible treatment for CML patients who are already on TKI therapy. ABL001 may work by blocking enzymes needed for cell growth. Giving ABL001 and TKI together may be more effective than TKI alone.
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?
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- I have had a heart attack or severe heart issues in the last 6 months.I am allergic or have had a bad reaction to ABL001 or its ingredients.I am not taking strong medication that affects liver enzymes or cannot stop it before starting the study treatment.I agree to use effective birth control during and after the study.I am not pregnant, nursing, or if capable of becoming pregnant, I am using effective birth control.I've been on TKI therapy for 2+ years without changes in the last 6 months.My leukemia is positive for the Philadelphia chromosome or BCR-ABL1.I am currently on nilotinib or dasatinib at a standard dose or lower.I don't have heart rhythm problems or a family history of sudden death.My heart's pumping ability is significantly reduced.I have an active HIV, hepatitis B, or hepatitis C infection.I have a condition that affects how my body absorbs pills.My cancer is in a controlled phase according to recent tests.My leukemia has not responded well enough to my current treatment.I haven't stopped my TKI therapy for more than 14 days at a time, except for specific reasons.I can take care of myself and do some daily activities.I have had acute pancreatitis in the last year or have chronic pancreatitis.I haven't had any cancer except for basal cell skin cancer or treated carcinoma in situ in the last 2 years.
- Group 1: Treatment (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
Has Asciminib been tested in any other previous trials?
"Presently, 15 separate trials are evaluating the effects of Asciminib. Of those investigations 4 have progressed to Phase 3. Predominantly located in Houston, Texas, this medical intervention is being studied at 487 sites worldwide."
Is this study presently open to enrollment?
"Affirmative. Clinicaltrials.gov confirms that this clinical trial, whose initial listing was on July 29th 2020 is presently seeking volunteers. 40 individuals need to be recruited from a single location for the study to move forward."
How many participants are currently taking part in this medical research?
"Affirmative, the information hosted on clinicaltrials.gov declares that this study is actively searching for participants. This particular trial was initially listed on July 29th 2020 and most recently updated February 1st 2022; they are seeking 40 individuals at a single medical centre."
Is this medical experiment novel in its approach?
"The development of Asciminib has been tracked since 2014 when it was first trialled by Novartis Pharmaceuticals. It progressed to Phase 1 approval after a 326 patient trial in the same year and is now being tested in 15 different clinical studies spanning 45 countries and 146 cities."
Has the FDA accepted Asciminib as a viable treatment option?
"Asciminib is rated a 2, as the Phase 2 trial implies that while there has been evidence of safety, efficacy hasn't yet been demonstrated."
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