Asciminib for Chronic Myeloid Leukemia
(AIM4CML Trial)
Recruiting at40 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Novartis Pharmaceuticals
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
This study will be a multicenter Phase IIIb open-label, three-cohort study of asciminib in patients with CML-CP without T315I mutation who have had at least 2 prior TKIs and CML-CP harboring the T315I mutation with at least 1 prior TKI
Research Team
Eligibility Criteria
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.Inclusion Criteria
I am 18 or older with a diagnosis of chronic myeloid leukemia in the chronic phase.
The number of immature blood cells (blasts and promyelocytes) in your blood and bone marrow is less than 30%.
Evidence of typical BCR-ABL1 transcript at screening
See 18 more
Exclusion Criteria
My chronic myeloid leukemia has progressed before but is now in a second chronic phase.
I have a bleeding disorder that is not caused by my cancer.
I have never had a reaction to asciminib or its ingredients.
See 11 more
Treatment Details
Interventions
- ABL001 (Tyrosine Kinase Inhibitor)
Trial OverviewThe 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.
Participant Groups
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)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD