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A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)

    • Novartis Pharmaceuticals

    Project: Clinical Trial

    Project Details

    Description

    The study is designed to compare the tolerability of asciminib versus nilotinib for the treatment of newly diagnosed, previously untreated patients with Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).

    Layman's description

    This study is a phase IIIb, multi-center, open-label, randomized study of oral asciminib 80 mg once daily (QD) versus nilotinib 300 mg twice daily (BID) in adult patients with newly diagnosed Ph+ CML-CP.

    Participants will be randomized in the study in a 1:1 ratio to asciminib or nilotinib. No crossover of study treatment across arms will be allowed.

    Participants will be treated until unacceptable toxicity, disease progression and/or at the discretion of the investigator or the participants. A safety follow up visit/call will be performed approximately 30 days after end of treatment visit. Participants who discontinue study treatment prematurely due to any reason, will be followed up for survival and progression (to Accelerated Phase (AP)/Blast Crisis (BC)) up until end of study.
    AcronymASC4START
    StatusActive
    Effective start/end date21/11/2215/03/27

    Collaborative partners

    Keywords

    • Chronic Myelogenous Leukemia
    • Chronic Myeloid Leukemia
    • Leukemia
    • ABL001
    • Phase 3
    • Tyrosine Kinase Inhibitor
    • Chronic Myelocytic Leukemia
    • Chronic Granulocytic Leukemia
    • cancer of the white blood cells
    • clonal bone marrow stem cell disorder proliferation of mature
    • Granulocytes
    • Chronic Myeloproliferative Disorders
    • Neoplasms by Histologic Type
    • Neoplasms
    • Hematologic Diseases
    • Myeloproliferative Disorders
    • Bone Marrow Diseases
    • Chronic Disease
    • Disease Attributes
    • Pathologic Processes
    • Translocation, Genetic
    • Chromosome Aberrations
    • Leukemia, Myeloid
    • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
    • Philadelphia Chromosome
    • Tyrosine Kinase Inhibitors
    • Protein Kinase Inhibitors
    • Enzyme Inhibitors
    • Molecular Mechanisms of Pharmacological Action
    • Nilotinib
    • Asciminib

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