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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03578367
Registration number
NCT03578367
Ethics application status
Date submitted
15/06/2018
Date registered
6/07/2018
Date last updated
8/08/2025
Titles & IDs
Public title
Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
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Scientific title
A Phase 2, Multi-center, Open-label, Randomized Study of Oral Asciminib Added to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients With CML-CP Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response
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Secondary ID [1]
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2018-001594-24
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Secondary ID [2]
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CABL001E2201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
CML
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Chronic Myelogenous Leukemia
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Leukemia, Myeloid Chronic
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Hematologic Diseases
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Condition category
Condition code
Cancer
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Leukaemia - Chronic leukaemia
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Blood
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Haematological diseases
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Asciminib add-on
Treatment: Drugs - Imatinib
Treatment: Drugs - Nilotinib
Experimental: Asciminib 60mg QD + Imatinib 400mg QD - Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
Experimental: Asciminib 40mg QD + Imatinib 400mg QD - Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
Active comparator: Imatinib 400mg QD - Imatinib 400 mg taken once daily
Active comparator: Nilotinib 300mg BID - Nilotinib 300 mg taken twice daily
Treatment: Drugs: Asciminib add-on
Asciminib 60 mg or 40 mg taken orally once daily.
Treatment: Drugs: Imatinib
Imatinib 400 mg taken orally once daily
Treatment: Drugs: Nilotinib
Nilotinib 300 mg taken orally twice daily (total daily dose of 600 mg)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Molecular Response (MR)^4.5 Rate at 48 Weeks
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Assessment method [1]
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Percentage of participants still treated with the randomized treatment at 48 weeks and are in MR4.5 (BCR::ABL1 ratio of = 0.0032%) at 48 weeks (± assessment window), among all participants in the asciminib add-on arms vs imatinib arm.
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Timepoint [1]
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at Week 48
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Secondary outcome [1]
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Rate of MR^4.5 at 48 Weeks
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Assessment method [1]
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Percentage of participants in MR\^4.5 (BCR-ABL1 ratio of = 0.0032%) at 48 weeks in asciminib add-on arms vs nilotinib arm.
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Timepoint [1]
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at Week 48
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Secondary outcome [2]
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Rate of MR^4.5 by 48 Weeks
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Assessment method [2]
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Best observed MR4.5 rate up to 48 weeks. This includes the percentage of participants who achieved MR 4.5 anytime up to 48 weeks.
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Timepoint [2]
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by 48 weeks
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Secondary outcome [3]
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Rate of MR^4.5 at 96 Weeks
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Assessment method [3]
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Percentage of participants with MR\^4.5 (BCR-ABL1 ratio of = 0.0032%) at 96 weeks
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Timepoint [3]
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at 96 weeks
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Secondary outcome [4]
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Rate of MR^4.5 by 96 Weeks
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Assessment method [4]
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Best observed MR4.5 rate up to 96 weeks
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Timepoint [4]
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by 96 weeks
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Secondary outcome [5]
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Sustained MR^4.5 From 48 Weeks Until 96 Weeks
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Assessment method [5]
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Percentage of participants who are in MR\^4.5 at 48 weeks and 96 weeks and who have no loss of MR\^4.5 in between those 2 time points.
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Timepoint [5]
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at 96 weeks
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Secondary outcome [6]
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Time to MR^4.5
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Assessment method [6]
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Time to MR\^4.5 is the time from first dose to first MR\^4.5 (BCR-ABL1 ratio of = 0.0032%) computed only for participants who achieved MR\^4.5.
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Timepoint [6]
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96/48 weeks after the last rand./enrolled (asciminib 80mg cohort) participant received the first study dose
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Secondary outcome [7]
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Duration of MR^4.5
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Assessment method [7]
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Time from first MR\^4.5 (BCR-ABL1 ratio of = 0.0032%) until loss of MR\^4.5.
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Timepoint [7]
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96/48 weeks after the last rand./enrolled (asciminib 80mg cohort) participant received the first study dose
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Secondary outcome [8]
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Pharmacokinetic Profile of Asciminib and Imatinib When Administered in Combination - Cmax
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Assessment method [8]
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The maximum (peak) observed drug concentration after dose administration
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Timepoint [8]
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up to 96 weeks
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Secondary outcome [9]
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Pharmacokinetic Profile of Asciminib and Imatinib When Administered in Combination - Tmax
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Assessment method [9]
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The time to reach maximum (peak) drug concentration after dose administration
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Timepoint [9]
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up to 96 weeks
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Secondary outcome [10]
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Pharmacokinetic Profile of Asciminib and Imatinib When Administered in Combination - Cmin
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Assessment method [10]
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Minimum drug concentration
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Timepoint [10]
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up to 96 weeks
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Secondary outcome [11]
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Pharmacokinetic Profile of Asciminib and Imatinib When Administered in Combination - AUClast
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Assessment method [11]
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The AUC from time zero to the last measurable concentration sampling time (Tlast)
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Timepoint [11]
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up to 96 weeks
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Secondary outcome [12]
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Pharmacokinetic Profile of Asciminib and Imatinib When Administered in Combination - AUCtau
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Assessment method [12]
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The AUC calculated to the end of a dosing interval (tau) at steady-state
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Timepoint [12]
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up to 96 weeks
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Secondary outcome [13]
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MR^4.5 Rate at 48 Weeks
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Assessment method [13]
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The percentage of participants on asciminib 80mg QD with MR\^4.5 (BCR-ABL1 ratio of = 0.0032%) at 48 weeks
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Timepoint [13]
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at 48 weeks
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Secondary outcome [14]
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Pharmacokinetic Profile of Asciminib 80mg QD - Cmax
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Assessment method [14]
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The maximum (peak) observed drug concentration after dose administration
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Timepoint [14]
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up to 48 weeks
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Secondary outcome [15]
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Pharmacokinetic Profile of Asciminib 80mg QD - Tmax
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Assessment method [15]
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The time to reach maximum (peak) drug concentration after dose administration
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Timepoint [15]
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up to 48 weeks
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Secondary outcome [16]
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Pharmacokinetic Profile of Asciminib 80mg QD - Cmin
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Assessment method [16]
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Minimum drug concentration
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Timepoint [16]
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up to 48 weeks
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Secondary outcome [17]
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Pharmacokinetic Profile of Asciminib 80mg QD - AUClast
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Assessment method [17]
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The AUC from time zero to the last measurable concentration sampling time (Tlast)
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Timepoint [17]
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up to 48 weeks
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Secondary outcome [18]
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Pharmacokinetic Profile of Asciminib 80mg QD - AUCtau
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Assessment method [18]
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The AUC calculated to the end of a dosing interval (tau) at steady-state
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Timepoint [18]
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up to 48 weeks
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Eligibility
Key inclusion criteria
* Male or female patients = 18 years of age with a confirmed diagnosis of Chronic Myeloid Leukemia in chronic phase (CML-CP).
* Minimum of one year (12 calendar months) treatment with imatinib first line for CML-CP (patients have to be on imatinib 300mg or 400 mg QD at randomization
For Korea only:
(i)a minimum of one year (12 calendar months) of prior treatment with imatinib for patients with BCR-ABL 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 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
* Participantss 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.
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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 kinese 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
* Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
* Risk factors for Torsades de Pointes
* Concomitant medications with a "known" risk of Torsades de Pointes
* inability to determine the QTcF interval 5. Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection, uncontrolled clinically significant hyperlipidemia and high serum amylase) 6. History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis; on-going acute liver disease or history of chronic liver disease 7. History of other active malignancy within 3 years prior to randomization with the exception of basal cell skin cancer, indolent prostate cancer and carcinoma in situ treated curatively.
Other protocol defined inclusion/exclusion may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/11/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/02/2025
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Sample size
Target
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Accrual to date
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Final
104
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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Georgia
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United States of America
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State/province [2]
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Maryland
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Austria
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0
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Vienna
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0
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Canada
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Quebec
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0
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Czechia
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Brno Bohunice
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Denmark
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Copenhagen
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France
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Bordeaux
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Germany
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Dresden
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Italy
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MI
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0
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Italy
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State/province [10]
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RM
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Poland
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Krakow
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0
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Poland
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Warsaw
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0
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Poland
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Wroclaw
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0
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Portugal
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State/province [14]
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Lisbon
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Portugal
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Porto
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Russia
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Moscow
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Russia
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Saint Petersburg
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South Korea
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Gyeonggi-do
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Country [19]
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South Korea
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Seocho Gu
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Spain
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Andalusia
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0
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Spain
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0
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Catalonia
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0
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Spain
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0
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Madrid
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Spain
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Valencia
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Taiwan
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Changhua
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Taiwan
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Taoyuan District
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United Kingdom
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Liverpool
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United Kingdom
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London
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Country [28]
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United Kingdom
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib versus asciminib 80mg in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP)
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Trial website
https://clinicaltrials.gov/study/NCT03578367
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Trial related presentations / publications
Hughes TP, Saglio G, Geissler J, Kim DW, Lomaia E, Mayer J, Turkina A, Kapoor S, Cardoso AP, Nieman B, Quenet S, Cortes JE. Asciminib add-on to imatinib demonstrates sustained high rates of ongoing therapy and deep molecular responses with prolonged follow-up in the ASC4MORE study. J Hematol Oncol. 2024 Dec 18;17(1):125. doi: 10.1186/s13045-024-01642-6.
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Novartis Pharmaceuticals
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Address
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Country
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Phone
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1-888-669-6682
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/67/NCT03578367/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/67/NCT03578367/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03578367
Download to PDF