Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients

Phase 3

Completed

Conditions: Chronic Myeloid Leukemia

Interventions: Drug: Nilotinib

Registration Number: NCT01254188

Lead Sponsor: Novartis Pharmaceuticals

Brief Summary: This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 421

Inclusion Criteria

-Patients with chronic myeloid leukemia in the chronic phase diagnosed within 6 months of study entry

Exclusion Criteria

Treatment with tyrosine kinase inhibitor or other antileukemic agents or treatments (including HSCT) for longer than 2 weeks, with exception of hydroxyurea and/or anagrelide
Uncontrolled congestive heart failure or hypertension
Myocardial infarction or unstable angina pectoris within past 12 months
Known T315I mutations
QTcF >450 msec
Significant arrhythmias

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nilotinib	Nilotinib	300 mg BID

Primary Outcome Measures

Name	Time	Method
The Percentage of Patients Achieving MMR by 12 Months	12 months	MMR is defined as BCR-ABL ratio (%) on IS \<= 0.1% (corresponds to \>=3 log reduction of BCR-ABL transcripts from standardized baseline value). Clopper-Pearson method

Secondary Outcome Measures

Name	Time	Method
Time to Molecular Response at 24 Months	24 months	Estimated median time to first MMR by Kaplan-Meier method
Duration of Major Molecular Response	3, 6, 9, 12, 15, 18, 21, 24 Months after MMR was detected	Kaplan-Meier estimates of duration of first MMR among patients who achieved MMR (FAS) Duration of first MMR (months) = (Minimum date of (loss of first MMR , CML-related death, progression to AP/BC during study treatment, censoring) - date of first MMR + 1) / 30.4375
Complete Cytogenetic Response	6 months	Complete cytogenetic response (CCyR) is defined as a value of 0% Ph+ metaphases in bone marrow.
Percentage of Participants Estimated to Maintain Their First CCyR for 6, 12, 18, and 24 Months After the First CCyR Was Achieved as Determined by Kaplan Meier Estimatation.	6,12,18 and 24 months	\* CCyR = 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics. Duration of first CCyR (months) = (date of CCyR loss or censoring - date of first CCyR +1) / 30.4375
Overall Survival	3, 6, 9, 12, 15, 18, 21, 24 Months	OS was defined as the time between date of study entry and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.
Kaplan-Meier Estimates of Progression-free Survival	3,6,9,12,15,18,21,and 24 months	PFS was defined as the time from the date of study entry to the date of event defined as the first documented disease progression to AP/BC or the date of death from any cause occurring on treatment.
Kaplan-Meier Estimates of Failure-free Survival	3,6,9,12,15,18,21,and 24 months	Time to event (months) = (date of event or censoring - date of study entry + 1) / 30.4375. Date of event is the earliest date of the following events during treatment : discontinuation of nilotinib for nilotinib-related adverse events, death due to any cause, progression to AP or BC, loss of PCyR, loss of CCyR, loss of CHR. Time is censored at the date of last assessment in the trial for patients without event.