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Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib
Trial period: 
1 December 2012 to 31 January 2019
Clinical Trial reference link: 


A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients. 

Patients who started treatment with imatinib (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at least 3 years and have very small amount of leukemia cells remaining after the nilotinib (Tasigna) treatment will qualify for the study.

This study is not currently recruiting participants

Verified: February 2014 by Novartis

Sponsor: Novartis Pharmaceuticals

Inclusion Criteria

  • Male or female patients >= 18 years of age
  • ECOG Performance Status of 0, 1, or 2
  • Patient with diagnosis of BCR-ABL positive CML CP
  • Patient has received a minimum of 3 years of tyrosine kinase inhibitor treatment (first with imatinib (> 4 weeks) and then switched to nilotinib) since initial diagnosis
  • Patient has at least 2 years of nilotinib treatment prior to study entry.
  • Patient has achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening