Publikationsdatum:
2010-11-19
Beschreibung:
Abstract 209 Background: Although the majority of chronic phase (CP) Philadelphia positive (Ph+) chronic myelogenous leukemia (CML) patients (pts) achieve good disease control with imatinib, some pts demonstrate suboptimal responses. Early dose escalation or switching to nilotinib, a more potent BCR-ABL kinase inhibitor, as soon as suboptimal molecular response is recognised may improve response and disease outcome. Aim: To optimise clinical and molecular outcomes in Ph+ CML using imatinib (IM) as frontline therapy with selective IM dose escalation based on pharmacokinetic (PK) results and switching to nilotinib (NIL) in case of suboptimal response, or IM-intolerance. Method: TIDEL-II is a multicentre, single arm prospective ALLG trial in de novo CP-CML pts with 2 separate sequential cohorts. In Cohort I, pts are treated with IM 600mg/d up-front, aiming for BCR-ABL RQ-PCR target values of ≤ 10%, 1%, and 0.1% IS (major molecular response, MMR) at 3, 6, and 12 months respectively. Pts who do not reach these treatment targets are classified as suboptimal responders. Dose escalation to 800mg/d or maximal tolerated dose occurs if trough IM level is
Print ISSN:
0006-4971
Digitale ISSN:
1528-0020
Thema:
Biologie
,
Medizin
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