Clinical Trials /

A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia

NCT02130557

Description:

Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

Related Conditions:
  • Chronic Myeloid Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
  • Official Title: A Multicenter Phase 3 Randomized, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Diagnosed Chronic Phase (CP) Chronic Myelogenous Leukemia (CML)

Clinical Trial IDs

  • ORG STUDY ID: AV001
  • NCT ID: NCT02130557

Conditions

  • Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene (BCR-ABL) Positive

Interventions

DrugSynonymsArms
BosutinibBosutinib
ImatinibImatinib

Purpose

Phase 3, 2-arm, randomized, open label trial. Patients will be randomized to receive bosutinib or imatinib for the duration of the study.

Detailed Description

The study will be open for enrollment until the planned number of approximately 500 Philadelphia Chromosome Positive (Ph+) patients have been randomized (approximately 250 Ph+ patients in each treatment arm; a total of approximately 530 Ph+ and Ph- patients). All patients will be treated and/or followed for approximately 5 years (240 weeks) after randomization until the study has closed. Patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 5 years (240 weeks) after randomization.

Trial Arms

NameTypeDescriptionInterventions
BosutinibExperimentalBosutinib, 400 mg, oral administration once a day
  • Bosutinib
    ImatinibActive ComparatorImatinib, 400 mg, oral administration once a day
      • Imatinib

    Eligibility Criteria

    Inclusion Criteria:

    1. Molecular diagnosis of CP CML of ≤ 6 months (from initial diagnosis).

    2. Adequate hepatic, renal and pancreatic function.

    3. Age ≥ 18 years.

    Exclusion Criteria:

    1. Any prior medical treatment for CML, including tyrosine kinase inhibitors (TKIs), with the exception of hydroxyurea and/or anagrelide treatment, which are permitted for up to 6 months prior to study entry (signature of ICF) if suitably approved for use in the subject's region.

    2. Any past or current Central Nervous System (CNS) involvement, including leptomeningeal leukemia.

    3. Extramedullary disease only.

    4. Major surgery or radiotherapy within 14 days of randomization.

    5. History of clinically significant or uncontrolled cardiac disease.

    6. Known seropositivity to human immunodeficiency virus (HIV), current acute or chronic hepatitis B (hepatitis B surface-antigen positive), hepatitis C, cirrhosis or evidence of decompensated liver disease. Patients with resolved Hepatitis B can be included.

    7. Recent or ongoing clinically significant GI disorder, e.g. Crohn's Disease, Ulcerative Colitis, or prior total or partial gastrectomy.

    8. History of another malignancy within 5 years with the exception of basal cell carcinoma or cervical carcinoma in situ or stage 1 or 2 cancer that is considered adequately treated and currently in complete remission for at least l2 months.

    9. Current, or recent (within 30 days, or 5 half-lives of investigational product) participation in other clinical trials of investigational agents and/or containing interventional procedures deemed contrary to the objectives and conduct of this trial.

    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:The proportion of participants with Major Molecular Response (MMR) at 12 Months in the bosutinib arm with that of the imatinib arm
    Time Frame:12 Months
    Safety Issue:
    Description:MMR is defined as <0.1%Bcr-Abl1 on the International Scale (IS) by Real Time Quantitative Polymerase Chain Reaction (RT-PCR)

    Secondary Outcome Measures

    Measure:The proportion of participants with MMR at 18 Months in the bosutinib treatment group with the imatinib treatment group
    Time Frame:18 Months
    Safety Issue:
    Description:
    Measure:The duration of MMR in the bosutinib treatment group with the imatinib treatment group
    Time Frame:5 Years
    Safety Issue:
    Description:Duration of MMR is measured only for participants who initially respond to study medication.
    Measure:The proportion of participants with Complete Cytogenetic Response (CCyR) by 12 Months in both treatment groups
    Time Frame:12 Months
    Safety Issue:
    Description:CCyR is defined as absence of detectable Ph chromosomes in bone marrow aspirate
    Measure:The duration of CCyR in both treatment groups
    Time Frame:5 Years
    Safety Issue:
    Description:Duration of response is measured only for participants who initially respond to study medication.

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Active, not recruiting
    Lead Sponsor:Avillion Development 1 Limited

    Trial Keywords

    • Leukemia
    • Myelogenous
    • Chronic
    • BCR-ABL Positive
    • Bosutinib
    • Leukemia, Myeloid
    • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
    • Philadelphia Chromosome
    • Neoplasms by Histologic Type
    • Bone Marrow Diseases
    • Hematologic Diseases
    • Translocation, Genetic
    • Pathologic Processes
    • Imatinib
    • Therapeutic Uses
    • Pharmacologic Actions
    • Molecular Mechanisms of Pharmacological Action

    Last Updated

    September 16, 2015