Overview

This trial is active, not recruiting.

Condition leukemia, myeloid, ph1-positive
Treatment nilotinib
Phase phase 3
Targets BCR-ABL, KIT, PDGF
Sponsor Novartis Pharmaceuticals
Start date April 2013
End date April 2019
Trial size 619 participants
Trial identifier NCT01743989, 2012-005124-15, CAMN107AIC05

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
12 months of nilotinib consolidation (arm 1) plus 36 months of TFR phase
nilotinib
Nilotinib will be provided to patients for at least 24 or 36months. (depending if nilotinib re-initiation is necessary- nilotinib will be provided during nilotinib re-initiation phase)
(Active Comparator)
24 months of nilotinib consolidation plus 24 months of TFR phase
nilotinib
Nilotinib will be provided to patients for at least 24 or 36months. (depending if nilotinib re-initiation is necessary- nilotinib will be provided during nilotinib re-initiation phase)

Primary Outcomes

Measure
optimal duration of consolidation treatment with nilotinib 300 mg BID to ensure the highest rate of patients remaining in ≥MR4.0 12months after entering the TFR phase.
time frame: 48 months

Secondary Outcomes

Measure
To evaluate the proportion of patients who are eligible to suspend nilotinib therapy by achieving and maintaining a sustained ≥MR4.0 for at least 12 months during consolidation treatment with nilotinib 300 mg BID
time frame: 12 months
The kinetics of the molecular response in patients during induction/consolidation treatment with nilotinib 300 mg BID.
time frame: 24 or 36 months depending on randomized arm
The kinetics of the molecular response in patients during the TFR phase of the study in the two treatment arms.
time frame: 36months (arm1); 24 months (arm2)
Progression-free survival (PFS) rate during the TFR phase of the study.
time frame: 36 months (arm1); 24 months (arm2)
Treatment -free survival (TFS) during the TFR phase of the study
time frame: 36 months (arm1); 24 months (arm 2)
Overall survival (OS) rate during of the TFR phase of the study.
time frame: 36 months (arm1); 24 months (arm2)
Safety profile of nilotinib during the induction/consolidation treatment phase, the TFR phase, and during the treatment re-initiation phase.
time frame: 60 months

Eligibility Criteria

Male or female participants at least 18 years old.

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;

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Novartis.