QC-TFR1-ABL001 = Asciminib Used in Consolidation With Imatinib vs. Imatinib to Achieve TFR in CP-CML [Canada]
Study title
Asciminib used in consolidation with imatinib vs. imatinib to achieve TFR in CP-CML
Scientific title
A Phase 3, Multicenter, Randomized, Open-Label, Trial Evaluating the Efficacy and Safety of Asciminib Used in Consolidation With Imatinib v. Imatinib to Achieve Treatment-free Remission in Chronic Phase-Chronic Myelogenous Leukemia Patients
Type of study
Treatment discontinuation study
Phase
Current status
Recruiting
Other trial ID
ClinicalTrials.gov NCT05413915
What is the purpose of the study
The aim of this study is to assess if adding asciminib to imatinib in patients who have achieved and maintained stable deep molecular response (DMR) can lead to better rates of treatment-free remission (TFR) than imatinib alone in patients with chronic myelogenous leukemia in chronic phase (CML-CP).
What will happen during the study
This study consists of two phases: the consolidation phase (52 weeks) and the TFR follow-up phase.
In the consolidation phase, patients will be treated with asciminib 60 mg by mouth per day in addition to current dose mg imatinib (300 or 400 mg by mouth per day) compared to current dose imatinib alone. Patients who maintain MR4 during this consolidation phase can attempt stopping treatment and will continue in the TFR phase.
Key inclusion criteria
This study includes male or female patients who:
- are aged 18 years or older.
- have a confirmed diagnosis of CML-CP.
- have been receiving imatinib for more than 4 years, and are currently receiving:
- standard dose 400 mg by mouth once daily or
- 300 mg by mouth for at least 4 months.
- have CML in deep molecular response, defined as at least MR4 for at least 12 months, as documented by 3 or more polymerase chain reaction (PCR) tests performed over 12 months prior to randomization, showing BCR-ABL1 levels ≤ 0.01% IS (International Scale) and no result over >0.01%.
For patients receiving 300 mg imatinib once daily, at least 2 of those PCRs test results must have been obtained at least 3 months apart while on 300 mg imatinib.
Further criteria may apply. Please discuss these with your doctor or study staff.
Key exclusion criteria
This study does not include patients who:
- are known to be in second CP-CML after previous progression to accelerated phase (AP)/blast phase (BC) CML.
- have been treated with a tyrosine kinase inhibitor (TKI) other than imatinib.
- previously underwent allogeneic stem cell transplantation
- are known to have an atypical ABL1-BCR transcript that cannot be monitored by the IS system.
Further criteria may apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
Where can I find additional information
You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.
Study sponsor
Sarit E Assouline, Sponsor-Investigator, and Novartis
Scientific lead / contact
Sarit E Assouline, MD, MSc
SMBD Jewish General Hospital
CIUSSS West Central Montreal
Principal investigator
Sarit E Assouline, MD, MSc
SMBD Jewish General Hospital
CIUSSS West Central Montreal
Study centers / principal investigators
Canada
Hôpital Enfant-Jésus – CHUQ
Québec, Canada, G1J 1Z4
Principal Investigator: Robert Delage, MD
Quebec
Jewish General Hospital
Clinical Research Unit
Montreal, Quebec, H3T1E2
Principal Investigator: Sarit Assouline, MD
Hôpital Maisonneuve-Rosemont (CIUSSS EMTL)
Montréal, Quebec, Canada, H1T 2M4
Principal Investigator: Lambert Busque, MD
Hôpital Fleurimont – CHUS (CIUSSS Estrie)
Sherbrooke, Quebec, Canada, J1H 5N4
Principal Investigator: Vincent Éthier, MD