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Report for Clinical Trial NCT01254188

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Extending Molecular Responses With Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) Patients in Chronic Phase

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

NCT01254188 Chronic Myeloid Leukemia
MeSH:Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive
HPO:Chronic myelogenous leukemia Leukemia Myeloid leukemia

1 Interventions

Name: Nilotinib

Description: 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.
Type: Drug
Group Labels: 1

Nilotinib


Primary Outcomes

Description: 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

Measure: The Percentage of Patients Achieving MMR by 12 Months

Time: 12 months

Secondary Outcomes

Description: Estimated median time to first MMR by Kaplan-Meier method

Measure: Time to Molecular Response at 24 Months

Time: 24 months

Description: 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

Measure: Duration of Major Molecular Response

Time: 3, 6, 9, 12, 15, 18, 21, 24 Months after MMR was detected

Description: Complete cytogenetic response (CCyR) is defined as a value of 0% Ph+ metaphases in bone marrow.

Measure: Complete Cytogenetic Response

Time: 6 months

Description: * 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

Measure: 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: 6,12,18 and 24 months

Description: 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.

Measure: Overall Survival

Time: 3, 6, 9, 12, 15, 18, 21, 24 Months

Description: 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.

Measure: Kaplan-Meier Estimates of Progression-free Survival

Time: 3,6,9,12,15,18,21,and 24 months

Description: 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.

Measure: Kaplan-Meier Estimates of Failure-free Survival

Time: 3,6,9,12,15,18,21,and 24 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 T315I

Time is censored at the date of last assessment in the trial for patients without event.. 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 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 Chronic Myeloid Leukemia Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive null --- T315I ---

Time is censored at the date of last assessment in the trial for patients without event.. 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 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 Chronic Myeloid Leukemia Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive null --- T315I --- --- T315I ---



HPO Nodes


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