Spots Global Cancer Trial Database for Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation

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Trial Identification

Brief Title: Asciminib in Monotherapy for Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation

Official Title: An Open Label, Multi-center Phase IIIb Study of Asciminib (ABL001) Monotherapy in Previously Treated Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) With and Without T315I Mutation

Study ID: NCT04666259

Conditions

Chronic Myelogenous Leukemia - Chronic Phase

Interventions

ABL001

Study Description

Brief Summary: This study will be a multicenter Phase IIIb open-label, three-cohort study of asciminib in patients with CML-CP without T315I mutation who have had at least 2 prior TKIs and CML-CP harboring the T315I mutation with at least 1 prior TKI

Detailed Description: This trial consists of three periods: screening and baseline for up to 21 days, active treatment for up to 72 weeks and a safety follow up period for 30 days. One hundred and fifteen (115) patients with chronic myeloid leukemia in chronic phase (CML-CP) without T315I mutation who have had at least 2 prior Tyrosine Kinase Inhibitors (TKIs) and CML-CP with the T315I mutation with at least 1 prior TKI will be considered for the current study Informed consent will be obtained before any procedures are performed for the study including eligibility assessments. The results of the real time quantitative polymerase chain reaction (RQ-PCR) must be available prior to randomization and first dose of study treatment. Patients with CML-CP without T315I mutation will be randomly assigned to either cohort A or B. Patients with the T315I mutation will be enrolled in cohort C. During treatment period asciminib will be taken orally: Cohort A will be administered 40 mg twice a day, Cohort B will be administered 80 mg once a day and Cohort C will be administered 200 mg twice a day. The patients will be treated up to end of study treatment period defined as up to 72 weeks after the last patient receives the first dose. Patients may be discontinued from treatment with the study drug at any time due to unacceptable toxicity, disease progression and/or at the discretion of the investigator or the patient.