AIM4CML = Asciminib monotherapy for patients with CML-CP with and without T315I mutation [USA]
Study title
AIM4CML (CABL001AUS04) = Asciminib monotherapy for patients with CML-CP with and without T315I mutation
Scientific title
An Open Label, Multi-center Phase IIIb Study of Asciminib (ABL001) Monotherapy in Previously Treated Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation
Type of study
Trials that are no longer recruiting
Phase
Current status
No longer recruiting
Other trial ID
CABL001AUS04, ClinicalTrials.gov NCT04666259
What is the purpose of the study
This is a study of the safety and efficacy asciminib in CML-CP patients without T315I mutation who have been treated with at least 2 prior TKIs and CML-CP patients with the T315I mutation who have been treated with at least 1 prior TKI.
What will happen during the study
The study consists of three periods: screening and baseline for up to 21 days, treatment with asciminib tablets for up to 72 weeks and a safety follow up period for 30 days.
Patients with CML-CP without T315I mutation will be randomly assigned to either group A or B. Patients with the T315I mutation will be enrolled in group C. During the treatment period, group A will receive aciminib 40 mg twice a day, group B will receive 80 mg once a day and group C will receive 200 mg twice a day.
Key inclusion criteria
This study includes male or female patients who:
- are aged 18 years or older
- have been diagnosed with CML in chronic phase (CML-CP)
- meet the laboratory values specified in the study protocol
- have an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2
- have had mutation analysis testing performed 6 months before study entry
- have shown failure (as adapted from the 2020 ELN Recommendations) or are intolant to the most recent TKI therapy at the time of screening
Patients without the T315I mutation will have received at least 2 tyrosine kinase inhibitors (TKI)
Patients with the T315I mutation will have received 1TKI before study entry.
Key exclusion criteria
This study does not include patients who:
- have a known second chronic phase of CML after previous progression to advanced phase (AP) or blast crisis (BC)
- have undergone hematopeietic stem cell transplantation
Further criteria may apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study sponsor
Novartis Pharmaceuticals
Scientific lead / contact
Novartis Pharmaceuticals
Principal investigator
Novartis Pharmaceuticals
Study centers / principal investigators
United States
Alaska
Alaska Oncology and Hematology AOH
Anchorage, Alaska, 99508
Arizona
Cancer Treatment Centers of America
Phoenix, Arizona, 85027
California
Lundquist Inst BioMed at Harbor
Torrance, California, 90509-2910
Colorado
Rocky Mountain Cancer Centers USOR
Boulder, Colorado, 80304
Florida
Memorial Healthcare System
Hollywood, Florida, 33021
Florida Cancer Specialists-North
Saint Petersburg, Florida, 33705
Florida Cancer Specialists
Sarasota, Florida, 34232
Florida Cancer Specialists East
Stuart, Florida, 34994
Florida Cancer Specialists Panhandle
Tallahassee, Florida, 32308
Indiana
Indiana Blood and Marrow Institute
Beech Grove, Indiana, 46107
Kentucky
University of Kentucky
Lexington, Kentucky, 40536
Massachusetts
University of Massachusetts Medical Center
Worcester, Massachusetts, 01655
Michigan
Michigan Medicine University of Michigan
Ann Arbor, Michigan, 48109 5271
Missouri
Siteman Cancer Center
Saint Louis, Missouri, 63110
New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
North Carolina
Wake Forest University Baptist Medical Center
Outpatient Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
Texas
Texas Oncology P A
Dallas, Texas, 75251
University of TX MD Anderson Cancer Center
Houston, Texas, 77030
Texas Oncology Northeast Texas
Tyler, Texas, 75702