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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04971226
Registration number
NCT04971226
Ethics application status
Date submitted
8/06/2021
Date registered
21/07/2021
Date last updated
3/05/2024
Titles & IDs
Public title
A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
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Scientific title
A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase
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Secondary ID [1]
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2021-000678-27
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Secondary ID [2]
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CABL001J12301
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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:
Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Imatinib
Treatment: Drugs - Nilotinib
Treatment: Drugs - Bosutinib
Treatment: Drugs - Dasatinib
Treatment: Drugs - Asciminib
Experimental: Asciminib - Patients will take asciminib 80 mg QD under fasting conditions on ongoing basis; Patients will be randomized 1:1 asciminib versus Investigator selected TKIs
Active Comparator: Investigator selected TKIs - Patients will take on ongoing basis the Investigator selected TKIs that will include one of the below treatments:
Imatinib 400 mg QD administered with food Nilotinib 300 mg BID administered under fasting conditions Dasatinib 100 mg QD administered with or without a meal Bosotunib 400 mg QD administered with food
Treatment: Drugs: Imatinib
Comes in 100 mg and 400 mg tablets and taken orally
Treatment: Drugs: Nilotinib
Comes in 150 mg capsules and taken orally
Treatment: Drugs: Bosutinib
Comes in 100 mg and 400 mg tablets and taken orally
Treatment: Drugs: Dasatinib
Comes in 70 mg and 100 mg tablets and taken orally
Treatment: Drugs: Asciminib
Comes in 40 mg tablets and taken orally
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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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Major Molecular Response (MMR) at week 48
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Assessment method [1]
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Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL =0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
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Timepoint [1]
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at 48 weeks (48 weeks after last patient first dose)
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Secondary outcome [1]
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Major Molecular response at week 96
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Assessment method [1]
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Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL =0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
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Timepoint [1]
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at 96 weeks (96 weeks after last patient first dose)
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Secondary outcome [2]
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Time to discontinuation of study treatment due to Adverse Events (TTDAE)
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Assessment method [2]
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TTDAE is defined as the time from the date of first dose of study treatment to the date of discontinuation of study treatment due to Adverse Event (AE). For patients ongoing without study treatment discontinuation, on or prior to the analysis cut-off date, the time will be censored at the at the analysis cut-off date.
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Timepoint [2]
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96 weeks after last patient first dose
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Secondary outcome [3]
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Major Molecular response at scheduled data collection time points
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Assessment method [3]
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Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL =0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
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Timepoint [3]
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Planned total follow-up duration of 5 years
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Secondary outcome [4]
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Major Molecular response by scheduled data collection time points
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Assessment method [4]
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Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL =0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).
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Timepoint [4]
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Planned total follow-up duration of 5 years
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Secondary outcome [5]
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MR4.0 at scheduled data collection time points
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Assessment method [5]
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Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.0 is defined as a ratio BCR-ABL/ABL =0.01% on the international scale (ie, at least 4 log reduction from a standardized baseline value).
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Timepoint [5]
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Planned total follow-up duration of 5 years
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Secondary outcome [6]
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MR4.5 at all scheduled data collection time points
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Assessment method [6]
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Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.5 is defined as a ratio BCR-ABL/ABL =0.0032% on the international scale (ie, at least 4.5 log reduction from a standardized baseline value).
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Timepoint [6]
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Planned total follow-up duration of 5 years
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Secondary outcome [7]
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MR4.0 by scheduled data collection time points
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Assessment method [7]
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Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.0 is defined as a ratio BCR-ABL/ABL =0.01% on the international scale (ie, at least 4 log reduction from a standardized baseline value).
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Timepoint [7]
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Planned total follow-up duration of 5 years
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Secondary outcome [8]
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MR4.5 by all scheduled data collection time points
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Assessment method [8]
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Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.5 is defined as a ratio BCR-ABL/ABL =0.0032% on the international scale (ie, at least 4.5 log reduction from a standardized baseline value).
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Timepoint [8]
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Planned total follow-up duration of 5 years
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Secondary outcome [9]
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Complete Hematological response (CHR) at all scheduled data collection time points
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Assessment method [9]
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Hematologic response will be assessed by CBC and physical examination at each visit.
Complete Hematological Response (CHR) will be defined as all of the following present for = 4 weeks:
white blood cell(s) (WBC) count < 10 x 10^9/L PLT count < 450 x 10^9/L Basophils < 5% No blasts and promyelocytes in peripheral blood Myelocytes + metamyelocytes < 5% in peripheral blood No evidence of extramedullary disease, including spleen and liver
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Timepoint [9]
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Planned total follow-up duration of 5 years
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Secondary outcome [10]
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Complete Hematological response (CHR) by all scheduled data collection time points
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Assessment method [10]
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Hematologic response will be assessed by CBC and physical examination at each visit.
Complete Hematological Response (CHR) will be defined as all of the following present for = 4 weeks:
white blood cell(s) (WBC) count < 10 x 10^9/L PLT count < 450 x 10^9/L Basophils < 5% No blasts and promyelocytes in peripheral blood Myelocytes + metamyelocytes < 5% in peripheral blood No evidence of extramedullary disease, including spleen and liver
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Timepoint [10]
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Planned total follow-up duration of 5 years
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Secondary outcome [11]
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Complete Cytogenic response (CCyR) at Week 48 & Week 96
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Assessment method [11]
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The CCyR response status will be based on bone marrow assessment, in any patients who have this done due to a clinical indication
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Timepoint [11]
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at 48 weeks and at 96 weeks (48 weeks and 96 weeks after last patient first dose)
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Secondary outcome [12]
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Complete Cytogenic response (CCyR) by Week 48 & Week 96
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Assessment method [12]
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The CCyR response status will be based on bone marrow assessment, in any patients who have this done due to a clinical indication
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Timepoint [12]
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at 48 weeks and at 96 weeks (48 weeks and 96 weeks after last patient first dose)
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Secondary outcome [13]
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Duration of MMR
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Assessment method [13]
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Duration of MMR is defined as the time between the date of the first documented achievement of MMR and the earliest date of loss of MMR, treatment failure, progression to Accelerated Phase/Blast Crisis, or CML-related death
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Timepoint [13]
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Planned total follow-up duration of 5 years
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Secondary outcome [14]
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Duration of MR4.0
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Assessment method [14]
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Duration of MR4.0 is defined as the time between the date of the first documented achievement of MR4.0 and the earliest date of loss of MR4.0, treatment failure, progression to Accelerated Phase/Blast Crisis, or CML-related death
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Timepoint [14]
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Planned total follow-up duration of 5 years
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Secondary outcome [15]
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Duration of MR4.5
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Assessment method [15]
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Duration of MR4.5 is defined as the time between the date of the first documented achievement of MR4.5 and the earliest date of loss of MR4.5, treatment failure, progression to Accelerated Phase/Blast Crisis, or CML-related death
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Timepoint [15]
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Planned total follow-up duration of 5 years
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Secondary outcome [16]
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Time to first MMR
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Assessment method [16]
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Time to first MMR is defined as the time from the date of randomization to the date of the first documented occurrence of MMR. Time will be censored at the last molecular assessment date while on treatment, or the End Of Treatment (whichever comes first) for patients who have not experienced MMR.
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Timepoint [16]
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Planned total follow-up duration of 5 years
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Secondary outcome [17]
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Time to first MR4.0
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Assessment method [17]
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Time to first MR4.0 is defined as the time from the date of randomization to the date of the first documented occurrence of MR4.0. Time will be censored at the last molecular assessment date while on treatment, or the End Of Treatment (whichever comes first) for patients who have not experienced MR4.0.
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Timepoint [17]
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Planned total follow-up duration of 5 years
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Secondary outcome [18]
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Time to first MR4.5
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Assessment method [18]
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Time to first MR4.5 is defined as the time from the date of randomization to the date of the first documented occurrence of MR4.5. Time will be censored at the last molecular assessment date while on treatment, or the End Of Treatment (whichever comes first) for patients who have not experienced MR4.5.
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Timepoint [18]
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Planned total follow-up duration of 5 years
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Secondary outcome [19]
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BCR-ABL1=1% at scheduled data collection time points
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Assessment method [19]
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Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction.
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Timepoint [19]
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Planned total follow-up duration of 5 years
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Secondary outcome [20]
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BCR-ABL1=1% by scheduled data collection time points
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Assessment method [20]
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Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction.
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Timepoint [20]
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Planned total follow-up duration of 5 years
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Secondary outcome [21]
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Time to treatment failure (TTF)
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Assessment method [21]
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TTF is defined as the time from date of randomization to the first/earliest documented date of any of the following events: treatment failure as per ELN, Confirmed loss of MMR while on study treatment, discontinuation from study treatment due to any reason
For patients that have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the last study assessment date while on treatment, or the EOT (whichever comes first) .
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Timepoint [21]
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Planned total follow-up duration of 5 years
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Secondary outcome [22]
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Failure Free Survival (FFS)
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Assessment method [22]
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FFS is defined as the time from the date of randomization to the earliest occurrence of the following events: treatment failure per ELN, confirmed loss of MMR, progression to AP/BC, death from any cause.
For patients that have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the date of last study treatment assessment or last post-treatment follow-up.
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Timepoint [22]
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Planned total follow-up duration of 5 years
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Secondary outcome [23]
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Event Free Survival (EFS)
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Assessment method [23]
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EFS is defined as the time from the date of randomization to the earliest occurrence of the following events: treatment failure as per ELN, confirmed loss of MMR ,discontinuation of study treatment due to AE, progression to AP/BC, death from any cause.
For patients that have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the date of last study treatment assessment or last post-treatment follow-up.
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Timepoint [23]
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Planned total follow-up duration of 5 years
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Secondary outcome [24]
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Progression Free Survival (PFS)
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Assessment method [24]
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PFS is defined as the time from the date of randomization to the earliest occurrence of progression to AP/BC or death from any cause.
For patients that have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the date of last study treatment assessment or last post-treatment follow-up.
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Timepoint [24]
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Planned total follow-up duration of 5 years
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Secondary outcome [25]
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Overall Survival (OS)
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Assessment method [25]
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OS is defined as the time from the date of randomization to the date of death from any cause. For patients that have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the date of last contact before the cut-off date.
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Timepoint [25]
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Planned total follow-up duration of 5 years
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Secondary outcome [26]
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Trough plasma concentrations.
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Assessment method [26]
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Trough plasma concentration will measure the concentration of asciminib in the blood immediately before the next dose is administered.
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Timepoint [26]
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48 weeks after last patient first dose
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Secondary outcome [27]
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Pharmacokinetics (PK) of Asciminib: Cmax
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Assessment method [27]
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Cmax is the maximum serum concentration of asciminib during a dosing interval (mass x volume-1).
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Timepoint [27]
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48 weeks after last patient first dose
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Secondary outcome [28]
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PK of Asciminib: Tmax
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Assessment method [28]
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Tmax is the time to reach maximum (peak) plasma drug concentration after dose administration (time)
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Timepoint [28]
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48 weeks after last patient first dose
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Secondary outcome [29]
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PK of Asciminib: AUCtau and AUClast
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Assessment method [29]
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AUCtau is the area under the plasma concentration-time curve over the dosing interval. AUClast is the area under the plasma concentration-time curve from time zero (time of dose administration) to time of last measurable concentration (mass x time x volume-1)
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Timepoint [29]
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48 weeks after last patient first dose
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Secondary outcome [30]
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PK of Asciminib: CL/F
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Assessment method [30]
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CL/F is the apparent total body clearance of asciminib from plasma after oral administration (volume x time-1).
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Timepoint [30]
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48 weeks after last patient first dose
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Secondary outcome [31]
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Change from baseline in overall scores and individual scales of the EORTC QLQ-C30
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Assessment method [31]
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The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) consists of functioning scales, symptoms' scales, single-item scales and the global health status quality of life (QoL) scale. A high score for functional and QoL items/scales from the QLQ-30 represents better function and QOL. A high score in symptoms items from QLQ-30 represents worse symptoms.
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Timepoint [31]
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baseline, 48 weeks after last patient first dose, 96 weeks after last patient first dose
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Secondary outcome [32]
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Change from baseline in overall scores and individual scales of the EORTC QLQ-CML24
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Assessment method [32]
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The QLQ-CML24 consists of (i) 22 multi-scale items: impact on daily life, symptom burden, impact on worry/mood, satisfaction with care and information, (ii) 2 single items: body image problems, and satisfaction with social life.
A higher score on most of the item scales in QLQ-CML24 reflects a larger impairment in the corresponding domain, with the exception of the satisfaction with care and information, and problems and satisfaction with social life, where a higher score reflects a higher level of satisfaction.
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Timepoint [32]
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baseline, 48 weeks after last patient first dose, 96 weeks after last patient first dose
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Eligibility
Key inclusion criteria
- Participants eligible for inclusion in this study must meet all of the following
criteria:
1. Male or female patients = 18 years of age.
2. Participants with CML-CP within 3 months of diagnosis.
3. Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of
Philadelphia chromosome
- Documented chronic phase CML will meet all the below criteria (Hochhaus et al 2020):
- < 15% blasts in peripheral blood and bone marrow,
- < 30% blasts plus promyelocytes in peripheral blood and bone marrow,
- < 20% basophils in the peripheral blood,
- Platelet count = 100 x 109/L (= 100,000/mm3),
- No evidence of extramedullary leukemic involvement, with the exception of
hepatosplenomegaly.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0,or 1. 5.
Adequate end organ function as defined by:
- Total bilirubin < 3 x ULN; patients with Gilbert's syndrome may only be included
if total bilirubin = 3.0 x ULN or direct bilirubin = 1.5 x ULN
- Creatinine clearance (CrCl) = 30 mL/min as calculated using Cockcroft-Gault
formula,
- Serum lipase = 1.5 x ULN. For serum lipase > ULN - = 1.5 x ULN, value must be
considered not clinically significant and not associated with risk factors for
acute pancreatitis 6. Participants must have the following laboratory values
within normal limits or corrected to within normal limits with supplements prior
to randomization:
- Potassium (potassium increase of up to 6.0 mmol/L is acceptable if associated
with CrCl* = 90 mL/min)
- Total calcium (corrected for serum albumin); (calcium increase of up to 12.5
mg/dl or 3.1 mmol/L is acceptable if associated with CrCl* = 90 mL/min)
- Magnesium (magnesium increase of up to 3.0 mg/dL or 1.23 mmol/L if associated
with CrCl* = 90 mL/min)
- For patients with mild to moderate renal impairment (CrCl* = 30 mL/min and <90
mL/min) - potassium, total calcium (corrected for serum albumin) and magnesium
should be = LLN or corrected to within normal limits with supplements prior to
randomization.
- *CrCl as calculated using Cockcroft-Gault formula 7. Ability to provide written
informed consent prior to any study related screening procedures being performed.
8. Evidence of typical BCR-ABL1 transcript [e14a2 and/or e13a2] at the time of
screening which is amenable to standardized Real time quantitative polymerase
chain reaction (RQ-PCR) quantification.
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Minimum age
18
Years
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Maximum age
No limit
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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
1. Previous treatment of CML with any other anticancer agents including chemotherapy
and/or biologic agents or prior stem cell transplant, with the exception of
hydroxyurea and/or anagrelide. Treatment with either imatinib, or nilotinib, or
dasatinib or bosutinib for =2 weeks is allowed, but no other treatment with other
tyrosine kinase inhibitors prior to randomization is permitted.
2. Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS
involvement, lumbar puncture not required).
3. Impaired cardiac function or cardiac repolarization abnormality including but not
limited to any one of the following:
- History within 6 months prior to starting study treatment of myocardial
infarction (MI), angina pectoris, coronary artery bypass graft (CABG)
- Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia),
complete left bundle branch block, high-grade AV block (e.g., bifascicular block,
Mobitz type II and third degree AV block)
- QTc = 450 ms (male patients), =460 ms (female patients) on the average of three
serial baseline ECG (using the QTcF formula) as determined by central reading. If
QTcF = 450 ms and electrolytes are not within normal ranges, electrolytes should
be corrected and then the patient re-screened for QTc.
- 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 (TdP) including uncorrected hypokalemia or
hypomagnesemia, history of cardiac failure, or history of clinically
significant/symptomatic bradycardia
- Concomitant medication(s) with a "Known risk of Torsades de Pointes" per
www.crediblemeds.org/ that cannot be discontinued or replaced 7 days prior to
starting study drug by safe alternative medication.•Inability to determine the
QTcF interval
4. 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
arterial or pulmonary hypertension, uncontrolled clinically significant
hyperlipidemia). Please refer to Section 6.3.1
5. History of significant congenital or acquired bleeding disorder unrelated to cancer.
6. Major surgery within 4 weeks prior to study entry or who have not recovered from prior
surgery.
7. History of other active malignancy within 3 years prior to study entry with the
exception of previous or concomitant basal cell skin cancer and previous carcinoma in
situ treated curatively
8. History of acute pancreatitis within 1 year prior to randomization or medical history
of chronic pancreatitis.
9. History of chronic liver disease leading to severe hepatic impairment, or ongoing
acute liver disease.
Other protocol-defined Inclusion/exclusion criteria will 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
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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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
6/10/2021
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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
18/01/2028
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Actual
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Sample size
Target
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Accrual to date
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Final
404
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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0
Novartis Investigative Site - Kingswood
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Recruitment hospital [2]
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Novartis Investigative Site - Port Macquarie
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Recruitment hospital [3]
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Novartis Investigative Site - Adelaide
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Recruitment hospital [4]
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Novartis Investigative Site - SouthPort
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Recruitment postcode(s) [1]
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2747 - Kingswood
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Recruitment postcode(s) [2]
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2444 - Port Macquarie
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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4215 - SouthPort
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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0
Colorado
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
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0
Kentucky
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Massachusetts
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Country [5]
0
0
United States of America
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State/province [5]
0
0
North Carolina
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Oregon
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Country [7]
0
0
United States of America
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State/province [7]
0
0
South Dakota
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Tennessee
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Texas
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Country [10]
0
0
Austria
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State/province [10]
0
0
Upper Austria
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Country [11]
0
0
Belgium
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State/province [11]
0
0
Bruxelles
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Country [12]
0
0
Belgium
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State/province [12]
0
0
Leuven
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Country [13]
0
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Varna
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China
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Henan
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China
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Hubei
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China
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Jiangsu
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China
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Shanxi
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China
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China
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Zhejiang
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China
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Beijing
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China
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Lanzhou
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China
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Tianjin
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Czechia
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Czech Republic
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Czechia
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CZE
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Czechia
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Poruba
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Denmark
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Aarhus
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Denmark
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Finland
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Helsinki
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France
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Bordeaux
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Lyon
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France
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Nantes Cedex 1
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France
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Paris 10
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Germany
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Germany
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Jena
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Germany
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Debrecen
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Hungary
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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BO
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Italy
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MI
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Italy
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RE
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Italy
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RM
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Italy
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Aichi
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Fukuoka
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Japan
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Fukushima
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Japan
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Japan
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Hyogo
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Japan
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Okayama
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Japan
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Osaka
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Japan
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Tochigi
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Japan
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Yamanashi
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Japan
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Akita
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Japan
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Yamagata
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Country [65]
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Korea, Republic of
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Gyeonggi Do
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Seocho Gu
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Seoul
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Pahang
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Selangor
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Netherlands
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Amsterdam
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Bergen
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Oslo
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Portugal
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Porto
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Portugal
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Singapore
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Catalunya
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Madrid
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Sweden
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Goteborg
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Sweden
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Lund
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Stockholm
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Taichung
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United Kingdom
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London
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United Kingdom
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Nottingham
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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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Ethics approval
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Summary
Brief summary
The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator
selected TKI for the treatment of newly diagnosed, previously untreated patients with Ph+
CML-CP. The Investigator selected TKI will be one of the following treatment options for
first-line treatment of CML-CP - imatinib 400 mg QD or nilotinib 300 mg BID or dasatinib 100
mg QD or bosutinib 400 mg QD.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04971226
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04971226
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