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Completed

NCT Number: NCT01254188

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

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

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Key information

Conditions

Chronic Myeloid Leukemia Bone Marrow Diseases Chromosome Aberrations Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Philadelphia Chromosome Translocation, Genetic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Algiers, Bouzareah, Algeria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nilotinib

Drug

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 names: AMN107

Primary outcomes

  1. 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

Secondary outcomes

  1. Time to Molecular Response at 24 Months

    Time frame: 24 months

    Estimated median time to first MMR by Kaplan-Meier method

  2. 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

  3. Complete Cytogenetic Response

    Time frame: 6 months

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

  4. 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

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: ENESTxtnd

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2010
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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