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

Brief Summary:
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.

Rationale:
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.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 1058 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Open Label, Two Arm Phase III Study to Evaluate Treatment Free Remission (TFR) Rate in Patients With Philadelphia-positive CML After Two Different Durations of Consolidation Treatment With Nilotinib 300mg BID.
Actual Study Start Date: April 15, 2013
Estimated Primary Completion Date: May 28, 2020
Estimated Study Completion Date: May 28, 2020

Arm:
- Active Comparator: arm 1
- Active Comparator: arm 2