Last updated on August 2020

A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic myeloid leukemia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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;

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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