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AIM4CML = Asciminib monotherapy for patients with CML-CP with and without T315I mutation [USA]

Type of study

Therapy optimization trial

Phase

3

Current status

Recruiting

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)

Other trial ID

CABL001AUS04

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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

June 2022

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
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

Indiana

Indiana Blood and Marrow Institute
Beech Grove, Indiana, 46107
Principal Investigator: Luke P Akard

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