Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients (ENESTxtnd)
|ClinicalTrials.gov Identifier: NCT01254188|
Recruitment Status : Completed
First Posted : December 6, 2010
Results First Posted : March 3, 2016
Last Update Posted : March 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia||Drug: Nilotinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||421 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Extending Molecular Responses With Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) Patients in Chronic Phase|
|Study Start Date :||April 2011|
|Primary Completion Date :||November 2014|
|Study Completion Date :||November 2014|
300 mg BID
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.
Other Name: AMN107
- The Percentage of Patients Achieving MMR by 12 Months [ Time Frame: 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 to Molecular Response at 24 Months [ Time Frame: 24 months ]Estimated median time to first MMR by Kaplan-Meier method
- Duration of Major Molecular Response [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254188
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|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|