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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
Must not have
Impaired cardiac function or cardiac repolarization abnormality including specific conditions and QTc intervals
History of significant congenital or acquired bleeding disorder unrelated to cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up planned total follow-up duration of 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing a new drug called asciminib against other existing treatments for adults newly diagnosed with a specific type of leukemia. The goal is to see if asciminib is more effective at blocking a protein that helps cancer cells grow. Asciminib has shown superior efficacy in patients with chronic myeloid leukemia (CML) previously treated with multiple other treatments.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My heart function is not normal, or I have an abnormal heart rhythm.
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I have a history of serious bleeding problems not related to cancer.
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I have a long-term liver condition causing severe liver damage.
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I have a history of pancreatitis.
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I haven't had major surgery in the last 4 weeks or am still recovering from one.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Major Molecular Response (MMR) at week 48
Secondary study objectives
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 moreAwards & Highlights
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.
Trial 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Chronic Myeloid Leukemia (CML) are tyrosine kinase inhibitors (TKIs) such as imatinib, dasatinib, nilotinib, and bosutinib. These drugs target the BCR-ABL fusion protein, a constitutively active tyrosine kinase resulting from the Philadelphia chromosome abnormality, which drives the uncontrolled proliferation of leukemic cells.
By inhibiting the BCR-ABL kinase activity, TKIs effectively reduce leukemic cell growth and induce remission. Asciminib, an allosteric inhibitor of ABL1 kinase, represents a novel approach by binding to a different site on the BCR-ABL protein, potentially overcoming resistance seen with other TKIs.
Understanding these mechanisms is crucial for CML patients as it directly impacts treatment efficacy, resistance management, and long-term outcomes.
Targeted chronic myeloid leukemia therapy: seeking a cure.
Targeted chronic myeloid leukemia therapy: seeking a cure.
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,893 Previous Clinical Trials
4,200,539 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.
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