This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
421
This was an open-label, single-arm, prospective, multi-center, Phase IIIb clinical study with nilotinib 300 mg bid treatment in newly diagnosed CML-CP patients not previously treated with imatinib therapy and diagnosed within 6 months of study entry. For patients insufficiently responding to nilotinib 300 mg bid, the dose may have been increased to 400 mg bid. Among patients with adverse events who had dose reduction, this study also allowed a possible re-escalation to 300 mg bid.
The Percentage of Patients Achieving MMR by 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
Time frame: 12 months
Time to Molecular Response at 24 Months
Estimated median time to first MMR by Kaplan-Meier method
Time frame: 24 months
Duration of Major Molecular Response
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
Time frame: 3, 6, 9, 12, 15, 18, 21, 24 Months after MMR was detected
Complete Cytogenetic Response
Complete cytogenetic response (CCyR) is defined as a value of 0% Ph+ metaphases in bone marrow.
Time frame: 6 months
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.
\* 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
Time frame: 6,12,18 and 24 months
Overall Survival
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.
Time frame: 3, 6, 9, 12, 15, 18, 21, 24 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Algiers, Bouzareah, Algeria
Novartis Investigative Site
Oran, Algeria
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina
Novartis Investigative Site
Caba, Buenos Aires, Argentina
Novartis Investigative Site
Paraná, Entre Ríos Province, Argentina
Novartis Investigative Site
Canberra, Australian Capital Territory, Australia
Novartis Investigative Site
Concord NSW, New South Wales, Australia
Novartis Investigative Site
Gosford, New South Wales, Australia
Novartis Investigative Site
Kingswood, New South Wales, Australia
Novartis Investigative Site
Kogarah, New South Wales, Australia
...and 90 more locations
Kaplan-Meier Estimates of Progression-free Survival
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.
Time frame: 3,6,9,12,15,18,21,and 24 months
Kaplan-Meier Estimates of Failure-free Survival
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.
Time frame: 3,6,9,12,15,18,21,and 24 months