Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response.
Completed · Phase 2
Conditions studied: CML, Chronic Myelogenous Leukemia, Leukemia, Myeloid Chronic, Hematologic Diseases
In brief
To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP). An asciminib single agent arm (80 mg daily) was added after the primary analysis to evaluate if asciminib alone could lead to MR4.5 patients in Imatinib for at least one year who have never achieved deep molecular response (DMR).
Key facts
- Study ID
- NCT03578367
- Run by
- Novartis Pharmaceuticals
- People needed
- 104
- Starts
- 2018-11-22
- Expected to finish
- 2025-02-26
- Last updated by the study team
- 2026-04-21
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female patients ≥ 18 years of age with a confirmed diagnosis of CML-CP.
- Minimum of one year (12 calendar months) treatment with imatinib first line for CML-CP (patients have to be on imatinib 400 mg QD at randomization and had no dose change in the past three months).
- For Korea only:
- (i) a minimum of one year (12 calendar months) of prior treatment with imatinib for patients with BCR::ABL1 levels > 0.1%, ≤ 1% IS at the time of randomization.
- (ii) a minimum of two years (24 calendar months) of prior treatment with imatinib for patients with BCR::ABL 1 levels > 0.01%, ≤ 0.1% IS at the time of randomization.
- BCR::ABL1 levels > 0.01% IS (International Scale) and ≤ 1% IS at the time of randomization as confirmed with a central assessment at screening; patients must not have achieved deep molecular response (MR4 IS) confirmed by 2 consecutive tests at any time during prior imatinib treatment. An isolated, single test result with BCR::ABL1 levels < 0.01 % (MR4 IS) is allowed, however, it should not have been observed within the 9 months prior to randomization
- Patient must meet the following laboratory values before randomization:
- Absolute Neutrophil Count ≥ 1.5 x 10E9/L
- Platelets ≥ 75 x 10E9/L
- Hemoglobin ≥ 9 g/dL
- Serum creatinine < 1.5 mg/dL
- Total bilirubin ≤ 1.5 x ULN (Upper Limit of Normal) except for patients with Gilbert's syndrome who may only be included with total bilirubin ≤ 3.0 x ULN
- Aspartate transaminase (AST) ≤ 3.0 x ULN
- Alanine transaminase (ALT) ≤ 3.0 x ULN
- Alkaline phosphatase ≤ 2.5 x ULN
- Serum lipase ≤ 1.5 x ULN
- Participants must have the following laboratory values ≥ Lower Limit of Normal or corrected to within normal limits with supplements prior to randomization: potassium increase of up to 6.0 mmol/L is acceptable if associated with creatinine clearance within normal limits ; calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with creatinine clearance* within normal limits) ; magnesium increase up to 3.0 mg/dL or 1.23 mmol/L if associated with creatinine clearance within normal limits.
- Key Exclusion Criteria:
- Treatment failure according to European Leukemia Network (ELN) criteria 2013 during imatinib treatment.
- Known second chronic phase of CML after previous progression to Accelerated Phase (AP)/Blast Crisis (BC).
- Previous treatment with any tyrosine kinase inhibitors (TKIs) other than imatinib.
- History or current diagnosis of ECG abnormalities indicating significant risk or safety for participants participating in the study such as:
- History of myocardial infarction, angina pectoris, coronary artery bypass graft within 6 months prior to randomization
- Concomitant clinically significant arrhythmias
- Resting QTcF ≥ 450 msec (male) or ≥ 460 msec (female) prior to randomization
Where it is running
- Georgia Regents University — Augusta, Georgia, United States
- Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States
- Novartis Investigative Site — Vienna, Austria
- Novartis Investigative Site — Montreal, Quebec, Canada
- Novartis Investigative Site — Brno, Czechia
- Novartis Investigative Site — Copenhagen, Denmark
- Novartis Investigative Site — Bordeaux, France
- Novartis Investigative Site — Dresden, Germany
- Novartis Investigative Site — Milan, MI, Italy
- Novartis Investigative Site — Roma, RM, Italy
- Novartis Investigative Site — Krakow, Poland
- Novartis Investigative Site — Warsaw, Poland
- Novartis Investigative Site — Wroclaw, Poland
- Novartis Investigative Site — Lisbon, Portugal
- Novartis Investigative Site — Porto, Portugal
- Novartis Investigative Site — Moscow, Russia
- Novartis Investigative Site — Moscow, Russia
- Novartis Investigative Site — Saint Petersburg, Russia
- Novartis Investigative Site — Saint Petersburg, Russia
- Novartis Investigative Site — Uijeongbu-si, Gyeonggi-do, South Korea
- Novartis Investigative Site — Seoul, South Korea
- Novartis Investigative Site — Badalona, Barcelona, Spain
- Novartis Investigative Site — Madrid, Spain
- Novartis Investigative Site — Seville, Spain
- Novartis Investigative Site — Valencia, Spain
Full record on ClinicalTrials.gov
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