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Imatinib dose reduction in CML
approach, the significance level of the two-sided P-value was 0.05 for all statistical tests. Analyses were carried out with SAS v.9.4 or R v.3.4.3.
Ethical approval
The CML-Study IV was performed in accordance with the Declaration of Helsinki, and was approved by the central ethics committee of the Medizinische Fakultaet Mannheim and the local ethics committees of all participating centers. Written informed consent was obtained from all patients prior to entering the CML- Study IV.
Results
Imatinib dose reduction in the 800 mg cohort of the Chronic Myeloid Leukemia-Study IV
Of 1551 patients with newly diagnosed chronic phase CML, 422 were randomly assigned to 800 mg imatinib per day. Of these, two patients violated CML-Study IV inclu-
sion criteria, ten were part of the pilot study, and a further ten were excluded from this analysis due to missing treat- ment data (see the CONSORT flow diagram in Figure 1).
Of the remaining 400 patients randomized to 800 mg imatinib, 92 patients had never received imatinib 800 mg/day and 163 patients never achieved MMR within the imatinib 800 mg/day interval. Of the remaining 145 patients, 39 had never reduced the 800 mg/day dose or had no observation time after dose reduction. A further 21 had an 800 mg/day interval of less than 6 months (i.e. not high-dose imatinib by our definition). Two patients were excluded because they had more than 6 weeks without any therapy between ending 800 mg/day imatinib and re- commencing 400 mg/day. Eight patients were not consid- ered because treatment with 400 mg/day lasted for less than 6 months. After exclusion of a further seven patients who had not been monitored by the central molecular diagnostic laboratory of the CML-Study IV, 68 patients were evaluable for our analyses.
Data entry was closed on July 21, 2015.
Figure 1. Flow diagram: patients of the Chronic Myeloid Leukemia-Study IV considered for final analysis.
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