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Clinical Trials

ALERTCML (CABL001AUS06T) = Asciminib as initial therapy for patients with CML in chronic phase [USA]

Study title

Asciminib as Initial Therapy for Patients with Chronic Myeloid Leukemia in Chronic Phase (ALERT)

Scientific title

Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase With Addition of Lower Dose Tyrosine Kinas Inhibitors for Patients With Chronic Myeloid Leukemia Who do Not Achieve a Deep Molecular Remission

Type of study

First line trial

Phase

2

Current status

Recruiting

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Other trial ID

HJKC3-0004; CABL001AUS06T; ClinicalTrials.gov NCT05143840

What is the purpose of the study

This study will evaluate the efficacy and safety of asciminib as first-line treatment for adult patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML-CP)

What will happen during the study

Patients will receive asciminib 80 mg by mouth once daily. Study participants will be treated and/or followed for 18 months. At this time point, the rate of patients obtaining molecular response (MR) 4.5 will be assessed. Patients who have not achieved a response after 24 months (but no later than 36 months) of treatment with asciminib alone will be offered addtional treatment with a low dose tyrosine kinase inhibitor, namely dasatinib, imatinib, or nilotinib at the investigator’s discretion.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged 18 years or older.
  • have been newly diagnosed with chronic myeloid leukemia in chronic phase (CML-CP) within 6 months of study entry.
  • have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR::ABL1 protein.
  • have been treated with minimal CML therapy with a tyrosine kinase inhibitor (TKI) for less than or equal to 30 days. Treatment with hydroxyurea, busulfan, anagrelide or other non-specific chemotherapy agents is allowed.
  • have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

  • have accelerated or blast phase CML.
  • have an active second malignancy requiring active treatment.
  • have had acute pancreatitis or chronic pancreatitis within the previous 12 months.
  • have previously received treatment with asciminib.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

February 2025

Where can I find additional information

You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.

Study sponsor

Augusta University
in collaboration with
H. Jean Khoury Cure CML Consortium

Scientific lead / contact

Contact: Kelly Jenkins
GCC Clinical Trials Office

Principal investigator

Jorge Cortes, MD
Augusta University

Study centers / principal investigators

United States

Georgia

Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912

Michigan

Karmanos Cancer Institute
Detroit, Michigan, 48201

New York

Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263

Memorial Sloan Kettering Cancer Center
New York, New York, 10065

Utah

Huntsman Cancer Institute
Salt Lake City, Utah,  84112

Wisconsin

Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226