CML Advocates Network

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 (ClinicalTrials.gov NCT04666259)

Indication and most important inclusion criteria

This study includes male or female patients 18 years and older with CML in chronic phase (CML-CP) who meet laboratory values specified in the study protocol.

Eligible patients must have had mutation analysis testing done 6 months before study entry. Patients without the T315I mutation will have received 2 tyrosine kinase inhibitors (TKIs) and patients with the T315I mutation will have received 1TKI before study entry.

Eligible patients must also have adequate end-organ function, and an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2.

Additional criteria may apply.

Short description of intervention

This is a study of the safety and efficacy asciminib in CML-CP patients without T315I mutation who have had at least 2 prior TKIs and CML-CP patients with the T315I mutation who have had at least 1 prior TKI.

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.

Type of study

Therapy optimization trial

Current status

Recruiting

Study sponsor

Novartis Pharmaceuticals

Scientific lead / contact

Novartis Pharmaceuticals

Principal investigator

Novartis Pharmaceuticals

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health 

Study centers / principal investigators

United States

Alaska

Alaska Oncology and Hematology AOH
Anchorage, Alaska, 99508
Principal Investigator: Steven Liu

Arizona

Cancer Treatment Centers of America
Phoenix, Arizona, 85027
Principal Investigator: Jeffrey Schriber

California

Lundquist Inst BioMed at Harbor
Torrance, California, 90509-2910
Principal Investigator: Sarah Tomassetti

Colorado

Rocky Mountain Cancer Centers USOR
Boulder, Colorado, 80304
Principal Investigator: David J Andorsky

Florida

Memorial Healthcare System
Hollywood, Florida, 33021
Principal Investigator: Yehuda Deutsch

Florida Cancer Specialists-North
Saint Petersburg, Florida, 33705
Principal Investigator: Jennifer L Cultrera

Florida Cancer Specialists
Sarasota, Florida, 34232
Principal Investigator: Fadi Kayali

Florida Cancer Specialists East
Stuart, Florida, 34994
Principal Investigator: Guillermo Abesada-Terk

Florida Cancer Specialists Panhandle
Tallahassee, Florida, 32308
Principal Investigator: Pareshkumar Patel

Kentucky

University of Kentucky
Lexington, Kentucky, 40536
rincipal Investigator: Reinhold Munker

Massachusetts

University of Massachusetts Medical Center
Worcester, Massachusetts, 01655
Principal Investigator: Jan Cerny

Michigan

Michigan Medicine University of Michigan
Ann Arbor, Michigan, 48109 5271
Principal Investigator: Moshe Talpaz

Missouri

Siteman Cancer Center
Saint Louis, Missouri, 63110
Principal Investigator: Camille N Abboud

New Jersey

Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Principal Investigator: Dale Schaar

Ohio

University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Principal Investigator: Emily Curran

Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
Principal Investigator: Edward R Broun

Texas

Texas Oncology P A
Dallas, Texas, 75251
Principal Investigator: Moshe Yair Levy

University of TX MD Anderson Cancer Center
Houston, Texas, 77030
Principal Investigator: Ghayas C Issa