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Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.

NCT02546674

Description:

The main purpose of this study is evaluation of deep molecular response (MR4.5; BCR-ABL IS < 0.0032%) after 24 months of therapy with nilotinib in newly diagnosed patients with chronic phase CML. Via the use of MR4.5 EUTOS ('European Treatment and Outcome Study for CML') laboratories adequate and reliable molecular monitoring as a key parameter for assessing molecular milestones is fostered. Furthermore this trial aims to investigate early prediction of outcome in newly diagnosed patients with nilotinib by assessing the individual decline of BCR-ABL transcripts. Quality of life will bemeasured via use of the EORTC CML-24 questionnaire.

Related Conditions:
  • Chronic Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Study Assessing Deep Molecular Response in Adult Patients With CML in Chronic Phase Treated With Nilotinib Firstline.
  • Official Title: A Phase IV Single Arm, Multicenter, Open-label Study Assessing Deep Molecular Response in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive CML in Chronic Phase After Two Years of Treatment With Nilotinib 300mg BID

Clinical Trial IDs

  • ORG STUDY ID: CAMN107ADE20
  • NCT ID: NCT02546674

Conditions

  • Chronic Myeloid Leukemia

Interventions

DrugSynonymsArms
NilotinibNilotinib

Purpose

The main purpose of this study is evaluation of deep molecular response (MR4.5; BCR-ABL IS < 0.0032%) after 24 months of therapy with nilotinib in newly diagnosed patients with chronic phase CML. Via the use of MR4.5 EUTOS ('European Treatment and Outcome Study for CML') laboratories adequate and reliable molecular monitoring as a key parameter for assessing molecular milestones is fostered. Furthermore this trial aims to investigate early prediction of outcome in newly diagnosed patients with nilotinib by assessing the individual decline of BCR-ABL transcripts. Quality of life will bemeasured via use of the EORTC CML-24 questionnaire.

Trial Arms

NameTypeDescriptionInterventions
NilotinibExperimentalPatients with newly diagnosed CML in chronic phase will be enrolled.
  • Nilotinib

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with newly diagnosed (within 6 months) Philadelphia chromosome positive CML
             in chronic phase; Patients must be previously untreated for CML with the exception of
             6 months treatment with hydroxyurea and a maximum of 6 weeks treatment with imatinib

        Exclusion Criteria:

        -Known impaired cardiac function like long QT syndrome, history of myocardial infarction or
        unstable angina in the past 12 months. Patients who are pregnant or breast feeding.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proportion of patients that achieve deep molecular response MR4.5 (IS) at 24 months of study treatment, measured in a standardized EUTOS MR4.5 laboratory
Time Frame:24 months
Safety Issue:
Description:The primary efficacy variable is the rate of MR4.5 at 24 months of study treatment measured in a standardized EUTOS MR4.5 laboratory. The rate of MR4.5 (IS) at 24 months of study treatment will be computed by dividing the number of patients who fit the definition of response at 24 months by the total number of patients in the analysis set.

Secondary Outcome Measures

Measure:Proportion of patients with MMR at 12 months of study treatment
Time Frame:12 months
Safety Issue:
Description:The rate of MMR at 12 months of study treatment will be computed by dividing the number of patients who fit the definition of response at 12 months by the total number of patients in the analysis set
Measure:Proportion of patients with CCyR at 6 months of study treatment
Time Frame:6 months
Safety Issue:
Description:Rate of CCyR at 6 months of study treatment will be calculated by dividing the number of patients who fit the definition of response at 6 month by the total number of Ph+ patients in the analysis set
Measure:Progression-free survival
Time Frame:up to 24 months
Safety Issue:
Description:Progression-free survival is defined as the time from the date of start of study treatment to the date of event defined as the first documented disease progression to AP/BC or the date of death from any cause, whichever is earlier
Measure:Proportion of patients with MR4 at 24 months of study treatment
Time Frame:24 months
Safety Issue:
Description:The rate of MR4 (IS) at 24 months of study treatment will be computed by dividing the number of patients who fit the definition of response at 24 months by the total number of patients in the analysis set
Measure:Individual reduction of BCR-ABL transcripts
Time Frame:3 months
Safety Issue:
Description:For determination of actual individual decline of transcripts a ratio will be established given by BCR-ABL/GUS at 3 months divided by BCR-ABL/GUS at diagnosis and referred to as 3-month reduction ratio.

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • Chronic Myeloid Leukemia
  • Nilotinib
  • Molecular Response
  • MR4.5

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