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Tyrosine Kinase Inhibitor

Asciminib + Imatinib for Chronic Myeloid Leukemia

Phase 2
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
Minimum of one year (12 calendar months) treatment with imatinib first line for CML-CP (patients have to be on imatinib 300mg or 400 mg QD at randomization)
For Korea only: (i) a minimum of one year (12 calendar months) of prior treatment with imatinib for patients with BCR-ABL levels > 0.1%, ≤ 1% IS at the time of randomization. (ii) a minimum of two years (24 calendar months) of prior treatment with imatinib for patients with BCR-ABL levels > 0.01%, ≤ 0.1% IS at the time of randomization.
Must not have
Previous treatment with any tyrosine kinase inhibitors (TKIs) other than imatinib
Severe and/or uncontrolled concurrent medical disease that could cause unacceptable safety risks or compromise compliance with the protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether adding asciminib to imatinib, or switching to asciminib+imatinib, is more effective than continuing imatinib alone, in people with CML who have already been treated with a TKI.

Who is the study for?
This trial is for adults over 18 with Chronic Myeloid Leukemia in chronic phase (CML-CP) who have been treated with imatinib for at least a year and haven't achieved deep molecular response. They must meet specific blood, liver, and kidney health criteria. Excluded are those with heart issues, history of pancreatitis or other cancers within the last 3 years, or previous treatment failures on imatinib.
What is being tested?
The study tests the effectiveness and safety of adding Asciminib to Imatinib versus continuing only Imatinib or switching to Nilotinib or using Asciminib alone in patients previously treated for CML-CP. It also examines how these drugs interact within the body.
What are the potential side effects?
Potential side effects may include changes in blood counts leading to increased infection risk, liver function abnormalities, digestive issues like pancreatitis, heart rhythm problems (QT prolongation), fatigue, and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated with imatinib for at least a year for my CML-CP.
Select...
In Korea, I've been treated with imatinib for at least 1 or 2 years based on my BCR-ABL levels.
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My BCR-ABL1 levels are low but not in deep molecular response.
Select...
I am 18 or older with chronic phase Chronic Myeloid Leukemia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been treated with a tyrosine kinase inhibitor other than imatinib.
Select...
I do not have any severe illnesses that could make this study unsafe for me.
Select...
I haven't had acute pancreatitis in the last year and don't have chronic pancreatitis or liver disease.
Select...
My leukemia did not respond to imatinib as per ELN 2013 criteria.
Select...
My chronic myeloid leukemia returned after it had previously worsened.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Molecular Response (MR)^4.5 rate between asciminib+imatinib and imatinib alone
Secondary study objectives
Difference in rate of MR^4.5 at 48 weeks
Duration of MR^4.5
Incidence and severity of adverse events, changes in laboratory values, clinically notable ECG abnormalities and vital signs
+15 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: Asciminib 80mg QDExperimental Treatment1 Intervention
Asciminib 80 mg taken once daily
Group II: Asciminib 60mg QD + Imatinib 400mg QDExperimental Treatment2 Interventions
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
Group III: Asciminib 40mg QD + Imatinib 400mg QDExperimental Treatment2 Interventions
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
Group IV: Imatinib 400mg QDActive Control1 Intervention
Imatinib 400 mg taken once daily
Group V: Nilotinib 300mg BIDActive Control1 Intervention
Nilotinib 300 mg taken twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imatinib
2011
Completed Phase 3
~3940

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,911 Previous Clinical Trials
4,250,551 Total Patients Enrolled

Media Library

Asciminib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03578367 — Phase 2
Hematological Disorders Research Study Groups: Asciminib 60mg QD + Imatinib 400mg QD, Asciminib 40mg QD + Imatinib 400mg QD, Imatinib 400mg QD, Nilotinib 300mg BID, Asciminib 80mg QD
Hematological Disorders Clinical Trial 2023: Asciminib Highlights & Side Effects. Trial Name: NCT03578367 — Phase 2
Asciminib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03578367 — Phase 2
~15 spots leftby Nov 2025
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