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

• Status: Completed
• Trial end date: 2021-03-25
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

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.