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

• Status: Completed
• Trial end date: 2020-07-08
• Target enrollment: 0
• Participant gender: All

Summary

This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained in treatment-free remission (≥MR4.0) without molecular relapse 12 months after starting the Treatment-Free Remission (TFR) phase.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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

Other inclusion/exclusion criteria might apply.