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Randomized Phase III Study to Assess the Effect of Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML
Recruitment period: 
1 May 2012 to 31 October 2018
Trial period: 
1 December 2013 to 1 January 2019
Clinical Trial reference link: 


This study is currently recruiting participants. (see Contacts and Locations)

Verified June 2014 by Novartis

Sponsor: Novartis Pharmaceuticals

Information provided by (Responsible Party): Novartis Pharmaceuticals


This study aims to assess the optimal duration of nilotinib 300 mg BID consolidation treatment, in order that patients remain in treatment-free remission (≥MR4.0) 12 months after starting the Treatment-Free Remission (TFR) phase of the study.


CP-CML patients who have received 2 or more calendar years of first-line imatinib treatment, and who have failed to achieve the molecular response threshold for treatment cessation (≥MR4.0) have a 50% greater chance of doing by switching to nilotinib; however the optimal duration of consolidation treatment with nilotinib to ensure the highest rate of patients remaining in ≥MR4.0 after entering the TFR phase is not yet known. This protocol therefore aims to assess the potential impact of a longer duration of consolidation treatment with nilotinib, i.e. 12 months versus 24 months, on molecular relapse rate in the first 12 months of treatment-free remission.


  • Ages Eligible for Study: 18 Years and older
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No

Key Inclusion Criteria

  • Confirmed diagnosis of chronic phase Ph+ CML
  • Previous first-line treatment with imatinib for a minimum of 2 years;
  • Patient in complete cytogenetic response;

Key Exclusion Criteria

  • Previous achievement of MR4.0 at study entry;
  • Previous treatment with other target cells inhibitors other than imatinib;
  • Patients with any history of detectable atypical Leukemia transcripts or patients with detectable atypical leukemia transcripts at screening;
  • Previous anticancer agents for Chronic myeloid leukemia other than imatinib except for cytoreduction;
  • Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol;
  • History of other active malignancies within the 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively;
  • Patients who have not recovered from prior surgery;
  • Treatment with other investigational agents within 4 weeks of Day 1;
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug;