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BCR-ABL Tyrosine Kinase Inhibitor

Asciminib + Imatinib for Chronic Myeloid Leukemia

Phase 3
Recruiting
Led By Sarit E Assouline, MD, MSc
Research Sponsored by Sarit Assouline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of 0-2
Male or female patients aged at least 18 years with a confirmed diagnosis of CML-CP
Must not have
Patients known to be in second CP-CML after previous progression to AP/BC-CML
Treatment with strong inducers/inhibitors of CYP3A4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tki discontinuation until loss of mr3 (up to 1 year)
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial aims to see if adding a new drug to an existing one can improve cancer treatment in Leukemia patients.

Who is the study for?
Adults diagnosed with Chronic Phase-Chronic Myelogenous Leukemia (CML-CP) who have been treated with imatinib for over 4 years and are in deep molecular response for at least a year. They must be able to conceive and agree to use effective contraception, have good organ function, no history of certain severe diseases or conditions that could affect trial participation, and not be on conflicting medications.
What is being tested?
The study is testing if adding asciminib to the current imatinib treatment leads to better rates of Treatment-Free Remission (TFR) compared to using imatinib alone in patients with CML-CP who are already responding well to treatment.
What are the potential side effects?
Potential side effects include digestive issues, liver enzyme changes, blood cell count variations, muscle cramps, bone pain, fatigue, rash or other skin problems. The severity can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am able to get out of my bed or chair and move around.
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I am 18 or older with confirmed chronic myeloid leukemia in the chronic phase.
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I have been taking a 400 mg or 300 mg oral medication daily for at least 6 months.
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My chronic myeloid leukemia has been in deep remission for at least a year.
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I have been on Imatinib for more than 4 years.
Select...
I have not had advanced chronic myeloid leukemia or resistance to specific leukemia treatment.
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I am not pregnant and will use effective birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My CML has returned to a chronic phase after worsening.
Select...
I am not taking medication that strongly affects liver enzyme CYP3A4.
Select...
I have had a transplant from another person.
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My cancer has a specific genetic feature that affects how it's monitored.
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I have been treated with a TKI medication that is not imatinib.
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I have a known infection with HIV, HBV, or HCV.
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I have had acute pancreatitis in the last year or suffer from chronic pancreatitis.
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I have a heart condition that poses a significant risk.
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I have had cancer other than my current diagnosis in the last 2 years.
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I am allergic to asciminib or its ingredients.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tki discontinuation until loss of mr3 (up to 1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and tki discontinuation until loss of mr3 (up to 1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-free survival rate
Secondary study objectives
Cumulative incidence of adverse events grade ≥ 3 in each arm, using CTCAE 5.0
Molecular relapse free rate
Time to molecular relapse

Awards & 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: Imatinib and AsciminibExperimental Treatment2 Interventions
Asciminib (60 mg PO daily for 52 weeks) will be added to standard of care imatinib (300 or 400 mg PO daily for 52 weeks)
Group II: ImatinibActive Control1 Intervention
Standard of care imatinib at 300 or 400 mg PO daily for 52 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Asciminib
2018
Completed Phase 1
~570
Imatinib
2011
Completed Phase 3
~3940

Find a Location

Who is running the clinical trial?

Sarit AssoulineLead Sponsor
2 Previous Clinical Trials
65 Total Patients Enrolled
1 Trials studying Leukemia
23 Patients Enrolled for Leukemia
NovartisIndustry Sponsor
1,639 Previous Clinical Trials
2,774,139 Total Patients Enrolled
60 Trials studying Leukemia
10,635 Patients Enrolled for Leukemia
Sarit E Assouline, MD, MScPrincipal InvestigatorSMBD Jewish General Hospital CIUSSS West Central Montreal

Media Library

Imatinib (BCR-ABL Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05413915 — Phase 3
Leukemia Research Study Groups: Imatinib and Asciminib, Imatinib
Leukemia Clinical Trial 2023: Imatinib Highlights & Side Effects. Trial Name: NCT05413915 — Phase 3
Imatinib (BCR-ABL Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05413915 — Phase 3
~62 spots leftby Dec 2025
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