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Tyrosine Kinase Inhibitor
Asciminib for Chronic Myeloid Leukemia (AIM4CML Trial)
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
ECOG performance status (PS) of 0, 1, or 2
Male or female patients with a diagnosis of CML-CP ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12, 24, 48, 72 weeks
Awards & highlights
AIM4CML Trial Summary
This trial will test the effectiveness of a new drug, asciminib, for treating chronic myeloid leukemia (CML). The trial will enroll patients who have previously been treated with other drugs for CML, and who either do or do not have a specific mutation (T315I).
Who is the study for?
This trial is for adults with Chronic Myeloid Leukemia in the chronic phase who have tried at least two prior treatments without the T315I mutation or one treatment with it. Participants must be over 18, not pregnant, and willing to use contraception. They should have adequate organ function and no recent other cancers or severe diseases.Check my eligibility
What is being tested?
The study tests Asciminib (ABL001) as a single therapy for patients with CML-CP who either harbor the T315I mutation after one previous treatment or do not after two treatments. It's an open-label Phase IIIb trial across multiple centers divided into three cohorts based on mutation status.See study design
What are the potential side effects?
Potential side effects of Asciminib may include low platelet counts, liver and kidney issues which are mild to moderate, gastrointestinal disturbances that could affect drug absorption, pancreatitis, bleeding disorders unrelated to cancer, and cardiac abnormalities.
AIM4CML Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 18 or older with chronic myeloid leukemia in the chronic phase.
Select...
I have taken 2 prior treatments without the T315I mutation.
Select...
I've had at least 2 treatments with TKIs or 1 if my cancer has the T315I mutation.
Select...
My last treatment with a TKI did not work or caused side effects.
Select...
My kidneys and liver are working well enough for treatment.
AIM4CML Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12, 24, 48, 72 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12, 24, 48, 72 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Adverse Events and Serious Adverse Events for cohorts A and B up to 24 weeks
Secondary outcome measures
Duration of CHR, MR2, MMR, MR4 and MR4.5 for cohorts A, B and C
Number of Adverse Events and Serious Adverse Events for cohorts A, B and C up to 24 weeks
Overall Survival Overall Survival (OS) for cohorts A, B and C
+4 moreAIM4CML Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort CExperimental Treatment1 Intervention
200 mg asciminib orally twice daily (BID)
Group II: Cohort BExperimental Treatment1 Intervention
80 mg asciminib orally once daily (QD)
Group III: Cohort AExperimental Treatment1 Intervention
40 mg asciminib orally twice daily (BID)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ABL001
2016
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,238 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older with a diagnosis of chronic myeloid leukemia in the chronic phase.My chronic myeloid leukemia has progressed before but is now in a second chronic phase.The number of immature blood cells (blasts and promyelocytes) in your blood and bone marrow is less than 30%.You have less than 20% of a specific type of white blood cell called basophils in your blood.I can take care of myself and am up and about more than half of my waking hours.You must read and sign a paper that explains the study and gives permission for you to participate.I have a bleeding disorder that is not caused by my cancer.I have never had a reaction to asciminib or its ingredients.My electrolyte levels are normal or have been corrected.I am 18 or older with chronic myeloid leukemia in the chronic phase.I have taken 2 prior treatments without the T315I mutation.You should not eat grapefruit or Seville oranges or drink any products made from them during the study.I've had at least 2 treatments with TKIs or 1 if my cancer has the T315I mutation.My last treatment with a TKI did not work or caused side effects.My kidneys and liver are working well enough for treatment.I have a heart condition affecting its rhythm.I have taken certain medications cautiously at least a week before the study treatment.I do not have any severe or uncontrolled health conditions.I have not had any cancer except for basal cell skin cancer or carcinoma in situ in the last 3 years.I had low platelet counts due to previous therapy, but it lasted less than 30 days.You are currently pregnant or breastfeeding.I am not using highly effective birth control methods.You had a genetic test six months prior to the study.You have at least 50 billion platelets per liter of blood.I have had a stem-cell transplant before.I have had acute pancreatitis in the last year or suffer from chronic pancreatitis.I have a digestive issue that could affect how I absorb medication.You have less than 15% immature blood cells in your blood or bone marrow.I am a sexually active male and agree to use a condom during the study and for 3 days after it ends.My leukemia hasn't spread outside my bone marrow, except maybe to my liver or spleen.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort A
- Group 2: Cohort B
- Group 3: Cohort C
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
If this clinical trial is available in more than one state, how many are participating?
"This clinical trial is currently enrolling patients at 22 different locations across the United States, including Florida Cancer Specialists East in Stuart, Alaska Oncology and Hematology AOH (2) in Anchorage, and University of Cincinnati Medical Center in Cincinnati."
Answered by AI
Are there other examples of ABL001's usage in a research setting?
"There are 477 research sites for ABL001 clinical trials spread across the globe, with 15 of them being active at the moment. Most of these studies are based in Port Macquarie, New South Wales, but ABL001 is being researched in many other locations."
Answered by AI
What predecessors does this research have?
"ABL001 has been the focus of clinical research for over seven years. The first trial, conducted in 2014 and sponsored by Novartis Pharmaceuticals, involved 326 patients. ABL001 received Phase 1 approval after the first study. As of today, there are 15 ongoing studies involving ABL001 across 146 cities and 45 countries."
Answered by AI
Are patients still being asked to join this clinical trial?
"Indeed, the trial is still seeking patients according to the latest update on the website. 115 subjects are needed in total, with 22 different centres looking for participants."
Answered by AI
What is the total projected enrollment for this research project?
"That is correct, the listed information on clinicaltrials.gov reveals that this study is still recruiting patients. The clinical trial was first posted on May 19th, 2021 and was most recently edited on April 22nd, 2022. The study is admitting 115 participants at 22 locations."
Answered by AI
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