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Tyrosine Kinase Inhibitor
Asciminib vs Other TKIs for Chronic Myeloid Leukemia
Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of Philadelphia chromosome
Adequate end organ function as defined by specific criteria for total bilirubin, creatinine clearance, and serum lipase
Timeline
Screening 3 weeks
Treatment Varies
Follow Up planned total follow-up duration of 5 years
Awards & highlights
Study Summary
This trial will compare the effectiveness of asciminib versus another treatment for newly diagnosed patients with a certain type of blood cancer.
Who is the study for?
Adults over 18 with newly diagnosed Ph+ CML-CP within the last 3 months, who haven't been treated for it yet. They must have normal or correctable levels of certain blood elements and organ functions, no severe heart issues or other serious medical conditions, and an ECOG performance status of 0 or 1.Check my eligibility
What is being tested?
The trial is testing Asciminib (80 mg daily) against other TKIs chosen by the investigator: Imatinib (400 mg daily), Nilotinib (300 mg twice a day), Dasatinib (100 mg daily), or Bosutinib (400 mg daily). It aims to find out which treatment works best for new CML-CP patients.See study design
What are the potential side effects?
Possible side effects include nausea, muscle pain, headaches, fatigue, digestive problems like diarrhea or constipation, skin rash and increased risk of infections. Heart rhythm problems could also occur but are monitored closely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia is in the chronic phase and has been confirmed to have the Philadelphia chromosome.
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My liver, kidneys, and pancreas are functioning well.
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My chronic myeloid leukemia is in the chronic phase without severe symptoms.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My leukemia has a specific genetic marker that can be measured.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ planned total follow-up duration of 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~planned total follow-up duration of 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Major Molecular Response (MMR) at week 48
Secondary outcome measures
BCR-ABL1≤1% at scheduled data collection time points
BCR-ABL1≤1% by scheduled data collection time points
Change from baseline in overall scores and individual scales of the EORTC QLQ-C30
+29 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AsciminibExperimental Treatment1 Intervention
Patients will take asciminib 80 mg QD under fasting conditions on ongoing basis; Patients will be randomized 1:1 asciminib versus Investigator selected TKIs
Group II: Investigator selected TKIsActive Control4 Interventions
Patients will take on ongoing basis the Investigator selected TKIs that will include one of the below treatments:
Imatinib 400 mg QD administered with food Nilotinib 300 mg BID administered under fasting conditions Dasatinib 100 mg QD administered with or without a meal Bosotunib 400 mg QD administered with food
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Asciminib
2018
Completed Phase 1
~570
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,196,946 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart function is not normal, or I have an abnormal heart rhythm.I was diagnosed with chronic myeloid leukemia in the chronic phase less than 3 months ago.I haven't had any other cancer except for certain types in the last 3 years.I have a history of serious bleeding problems not related to cancer.I have a long-term liver condition causing severe liver damage.My leukemia is in the chronic phase and has been confirmed to have the Philadelphia chromosome.I have CML and was treated with cancer drugs, but not the ones excluded.I have a history of pancreatitis.I am 18 years old or older.My liver, kidneys, and pancreas are functioning well.My chronic myeloid leukemia is in the chronic phase without severe symptoms.I am fully active or restricted in physically strenuous activity but can do light work.My leukemia has a specific genetic marker that can be measured.I haven't had major surgery in the last 4 weeks or am still recovering from one.
Research Study Groups:
This trial has the following groups:- Group 1: Investigator selected TKIs
- Group 2: Asciminib
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Asciminib for public use?
"Asciminib falls into our "safe" category, with a 3/3 score. This is because it's a Phase 3 trial, meaning that there is not just some data supporting efficacy, but multiple rounds of data confirming its safety."
Answered by AI
What has been the medical community's response to Asciminib thus far?
"Presently, there are one-hundred and forty different studies investigating Asciminib with twenty-nine in Phase 3. Many of the tests for this medication are taking place in Montreal, Quebec; however, 5884 other areas around the world are also running similar research."
Answered by AI
What has Asciminib been shown to be an effective treatment for?
"Refractory acute lymphoblastic leukemia (ALL) is most commonly treated with the medication asciminib. This drug is also used to manage other conditions, such as chordomas, blast phase, and refractory chronic phase chronic myeloid leukemia."
Answered by AI
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