Chronic Myelogenous Leukemia (ASCEMBL)
A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib (ABL001) Versus Bosutinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated With 2 or More Tyrosine Kinase Inhibitors.
|This Study Is Active, Not Recruiting: Phase III||Actual Start Date: [October 26, 2017]||Estimated Completion Date: [March 19, 2025]||Novartis Reference Number: CABL001A2301|
|Condition: Chronic Myelogenous Leukemia in Chronic Phase||Interventions: asciminib, bosutinib||Estimated Enrollment: [222 participants]||ClinicalTrials.gov Identifier: NCT03106779|
|This Study Is Active, Not Recruiting: Phase III||Actual Start Date: [October 26, 2017]|
|Estimated Completion Date: [March 19, 2025]||Novartis Reference Number: CABL001A2301|
|Condition: Chronic Myelogenous Leukemia in Chronic Phase||Interventions: asciminib, bosutinib|
|Estimated Enrollment: [222 participants]||ClinicalTrials.gov Identifier: NCT03106779|
The purpose of this study is to compare the efficacy of asciminib with that of bosutinib in the treatment of patients with CML-CP having previously been treated with a minimum of two prior ATP-binding site TKIs.
Patients intolerant to the most recent TKI therapy must have BCR-ABL1 ratio > 0.1% IS at screening and patients failing their most recent TKI therapy must meet the definition of treatment failure as per the 2013 ELN guidelines.
Patients with documented treatment failure while on bosutinib treatment will have the option to switch to asciminib treatment within 96 weeks after the last patient has been randomized on study.
Participants may be eligible to participate if they:
- Are 18 years or older
- Have a confirmed diagnosis of CML-CP
- Have prior treatment with a minimum of 2 prior ATP-binding site TKIs (i.e. imatinib, nilotinib, dasatinib, radotinib or ponatinib)
- Have failure (per ELN guidelines) or intolerance to the most recent TKI therapy
- Have a BCR-ABL1 ratio ≥ 0.1% IS, for patients intolerant to the most recent TKI therapy
- Meet other eligibility criteria
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To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.
Other chronic myelogenous leukemia trials you might be interested in:
A Phase II, Multicenter, 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.
ATP - Adenosine triphosphate, BCR-ABL1 - Breakpoint cluster region-Abelson murine leukemia, CML-CP - Chronic myelogenous leukemia in chronic phase, ELN - European LeukemiaNet, ICF - Informed consent form, IS - International Scale, TKI - Tyrosine kinase inhibitor
Last Updated: October 7, 2019