Your session is about to expire
← Back to Search
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
My BCR-ABL1 levels are low but not in deep molecular response.
Select...
I am 18 or older with chronic phase Chronic Myeloid Leukemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ by 48 weeks and 96 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~by 48 weeks and 96 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Molecular Response (MR)^4.5 rate between asciminib+imatinib and imatinib alone
Secondary outcome measures
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 moreTrial 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
2,855 Previous Clinical Trials
4,197,249 Total Patients Enrolled
151 Trials studying Leukemia
23,728 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with imatinib for at least a year for my CML-CP.I haven't had any other cancer besides this one in the last 3 years.In Korea, I've been treated with imatinib for at least 1 or 2 years based on my BCR-ABL levels.My BCR-ABL1 levels are low but not in deep molecular response.I have been treated with a tyrosine kinase inhibitor other than imatinib.I do not have any severe illnesses that could make this study unsafe for me.I haven't had acute pancreatitis in the last year and don't have chronic pancreatitis or liver disease.I am 18 or older with chronic phase Chronic Myeloid Leukemia.My leukemia did not respond to imatinib as per ELN 2013 criteria.My chronic myeloid leukemia returned after it had previously worsened.
Research Study Groups:
This trial has the following groups:- Group 1: Asciminib 60mg QD + Imatinib 400mg QD
- Group 2: Asciminib 40mg QD + Imatinib 400mg QD
- Group 3: Imatinib 400mg QD
- Group 4: Nilotinib 300mg BID
- Group 5: Asciminib 80mg QD
Awards:
This trial has 1 awards, including:- 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.
What does Asciminib add-on usually treat?
"Asciminib add-on is an effective treatment for newly diagnosed acute lymphoblastic leukaemia, refractory acute lymphoblastic leukemia (all), and muscular dystrophy."
Answered by AI
What other research has been conducted that uses Asciminib in combination with other treatments?
"As of now, 85 different Asciminib add-on trials are underway. Out of those, 22 are in the critical Phase 3 stage. Although a large portion of these trials are based in Monterrey, Nuevo Leon, there are 2946 total locations running these trials."
Answered by AI
Are there any dangers associated with using Asciminib in addition to other treatments?
"Since this is a phase 2 trial, there is some data suggesting that Asciminib add-on is safe, but none yet available to support that it is effective. Consequently, our team at Power has given it a score of 2."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger