Imatinib Continuation Versus Nilotinib 300 mg Twice Daily in Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase and Major Molecular Re-sponse (MMR) Without Molecular Response ≥ 4.5 Log (MR4.5) Receiving Imatinib at a Dose of 400 to 800 mg Daily. An Open-label, Randomised Multicenter Phase 3b Study to Determine the Confirmed Rate of Molecular Response ≥ 4 Log (MR4) at Two Years

Trial Profile

Imatinib Continuation Versus Nilotinib 300 mg Twice Daily in Patients With Chronic Myeloid Leukemia (CML) in Chronic Phase and Major Molecular Re-sponse (MMR) Without Molecular Response ≥ 4.5 Log (MR4.5) Receiving Imatinib at a Dose of 400 to 800 mg Daily. An Open-label, Randomised Multicenter Phase 3b Study to Determine the Confirmed Rate of Molecular Response ≥ 4 Log (MR4) at Two Years

Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Jun 2017

At a glance

  • Drugs Imatinib (Primary) ; Nilotinib
  • Indications Chronic myeloid leukaemia
  • Focus Therapeutic Use
  • Acronyms DECLINE
  • Most Recent Events

    • 10 Jun 2017 Biomarkers information updated
    • 02 Dec 2015 Treatment has been changed from imatinib 400 mg/day to imatinib 400-800 mg/day and inclusion criteria also amended as per ClinicalTrials.gov record.
    • 02 Dec 2015 Planned End Date changed from 1 Dec 2020 to 1 Dec 2024 ClinicalTrials.gov record.
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