Leukemia Clinical Trial
Official title:
An Open-label Multi-center Study of Imatinib and Nilotinib in CAMN107ECN02 On-treatment Patients With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase After the End of CAMN107ECN02 Core Study
The extension study followed the core study CAMN107ECN02 (NCT01275196). which is an open-label, two armed study. All patients enrolled in this extension study were able to benefit from the treatment given in CAMN107ECN02 per investigator's evaluation. Therefore, in this extension study patient continued treatment of the drug (imatinib or nilotinib) which they were taking at the end of CAMN107ECN02. Treatment arms in CAMN107ECN02 were retained. As long as EC approval and agreement from investigators were obtained, the selected sites for CAMN107ECN02 were applied in this extension study.
Up to 230 patients who benefited from the core study treatment (imatinib or nilotinib), at
Investigator's discretion, were enrolled into this extension study. The patients continued
receiving the open-label drugs that they were taken by the end of core study. Treatment arms
in the core study were retained. No crossover between the arms was allowed.
The extension study started from the first patient last dose date in the core study and ends
at the time of nilotinib was commercially available in China as a first line treatment.
Eligibility evaluations were given for each patient before the enrollment. Follow-up visits
at a frequency of 6 months were required to report AE, SAE and pregnancy only. No efficacy
data were collected in the extension study since full efficacy had already been analyzed in
the core study.
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