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Asciminib for Chronic Myeloid Leukemia (ASC2ESCALATE Trial)
ASC2ESCALATE Trial Summary
This trialwill test a new drug to treat chronic myeloid leukemia in those who haven't responded to other treatments.
ASC2ESCALATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:ASC2ESCALATE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ASC2ESCALATE Trial Design
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Who is running the clinical trial?
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- I have received previous treatment.I do not have Long QT syndrome or a family history of sudden death.I am not taking any strong drugs that affect liver enzymes with my 200 mg twice daily medication.I haven't had any cancer except for basal cell skin cancer or treated carcinoma in situ in the last 3 years.I experienced severe side effects from my cancer treatment that didn't improve with changes.I've had severe blood-related side effects from treatment, even after the dose was lowered.I have risk factors for a specific heart rhythm problem due to low potassium or magnesium, heart failure, or slow heartbeat.My BCR-ABL1 levels are above 10% after 6-12 months of first-line treatment.I have been treated with 2 or more TKIs.My first treatment with a TKI drug did not work.I have had a stem-cell transplant before.I can take care of myself and am up and about more than half of my waking hours.I am not taking medication that strongly activates CYP3A enzymes.My heart has no abnormalities.My BCR-ABL1 levels are above 0.1%.It's been over a year since I started my first-line TKI treatment.I have newly diagnosed chronic myeloid leukemia and may have had up to 4 weeks of treatment with specific drugs.You are allergic to the study treatment.I am planning to have a stem cell transplant from a donor.My chronic myeloid leukemia is in the early or chronic phase.I have never taken the medication Scemblix.I'm sorry, but it seems like there is no specific criterion provided. Could you please provide more information or context?I have not undergone a stem-cell transplant.I have had acute pancreatitis in the last year or have chronic pancreatitis.I have not taken ATP-binding site TKIs for my condition in the last 4 weeks.I am 18 years old or older.Intolerance means that you have a negative reaction or cannot tolerate something.My cancer has the T315I mutation.I have been treated with asciminib before.My first treatment for leukemia did not work as expected.My leukemia has worsened despite treatment for over a year.My organs are functioning well enough for treatment.
- 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 slots remaining in this research endeavor for participants?
"Yes indeed. The clinical trial, initially advertised on August 29th 2022 and recently amended on January 5th 2023, is registering 92 patients across 4 medical centres as indicated by the information hosted on ClinicalTrials.gov."
Has the FDA affirmed Asciminib for use in treatment?
"The safety of Asciminib was rated a 2 as this is still in phase two, and thus there are no long-term efficacy data but some short-term evidence supporting its security."
Are there a variety of locations offering this investigation in the city?
"Currently, Rocky Mountain Cancer Centers USOR in Boulder, Hematology Oncology Care in Cincinnati, and Texas Oncology P A TX Oncology Baylor in Dallas are actively recruiting. Additionally there 4 additional sites with available clinical trial positions."
How many participants have signed up for the research project?
"Affirmative. The clinicaltrials.gov website reveals that this study is currently seeking participants, having been initially posted on August 29th 2022 and last updated on January 5th 2023. From 4 different sites they are looking to find 92 individuals for enrolment into the trial."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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