An open-label, randomized study of dasatinib vs. high-dose (800 mg) imatinib in the treatment of subjects with chronic phase chronic myeloid leukemia who have had a suboptimal response after at least ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-005153-22

An open-label, randomized study of dasatinib vs. high-dose (800 mg) imatinib in the treatment of subjects with chronic phase chronic myeloid leukemia who have had a suboptimal response after at least 3 months of therapy with 400 mg imatinib. Revised Protocol 03, incorporating Administrative Letter 01 and Protocol Amendments 02 (Version 1.0, Dated 29-May-2007), 03 (Version 1.0, Dated 10-Oct-2007) and 04 (version 1.0, dated 10-Apr-08)

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Extrait

The primary objective of this study is to compare the rate of major molecular response of dasatinib (100 mg QD) to high-dose imatinib (800 mg, i.e. 400 mg BID) therapy at 12 months in chronic phase CML subjects, who had achieved only a suboptimal response after at least 3 months imatinib (400 mg) monotherapy prior to enrollment. A suboptimal response is defined as a hematologic response but less than Complete HR after at least 3 months; a cytogenetic response but less than a partial cytogenetic response (PCgR) after at least 6 months; a partial cytogenetic response after at least 12 months, or less than a major molecular response with complete cytogenetic response after at least 18 months. Additional 12 months of treatment: The primary objective is to collect longer term efficacy on dasatinib in terms of duration of major molecular response.


Critère d'inclusion

  • Subjects with Ph+ chronic phase Chronic Myeloid leukemia (CML)