TABLE 4Study design: RCT

StudyCPAPBCCountriesNo. of centresInclusion criteriaExclusion criteriaMethod of allocationBlindingTherapy common to all participants
Kantarjian et al. (2007),6 (2009)7 (additional references are given in table 6 of PenTAG AR2)[check]Argentina, Australia, Belgium, Brazil, Canada, Estonia, Finland, France, Germany, Israel, Republic of Korea, Norway, Peru, the Philippines, Poland, Puerto Rico, Russian Federation, South Africa, Sweden, Taiwan, Thailand, the UK and the USA58Participants with CP-CML and primary or acquired resistance to standard doses of imatinib (400–600 mg), dasatinib naive, at least 18 years of age and had adequate hepatic and renal function.

CP was defined by the presence of < 15% blasts, < 20% basophils and < 30% blasts plus promyelocytes in peripheral blood or bone marrow and a platelet count of at least 100,000 per mm3, with no extramedullary involvement

Primary resistance to imatinib was defined as a lack of CHR after 3 months of imatinib treatment, a lack of any CyR after 6 months of treatment or a lack of a MCyR (Ph+ cells > 35%) after 12 months of treatment. Relapse after a HR or MCyR was considered as secondary or acquired resistance
Participants who had received imatinib in the 7 days before the study were ineligible, as were participants who had received imatinib at doses in excess of 600 mg per day. Participants with known specific BCR–ABL mutations (with high resistance to imatinib) before study entry were excluded2:1
randomisation (no details of methods used)
Open labelNot reported

AP, accelerated phase; BC, blast crisis; BCR–ABL, oncogene fusion protein consisting of BCR and ABL genes; CHR, complete haematological response; CP, chronic phase; CP-CML, chronic-phase chronic myeloid leukaemia; CyR, cytogenetic response; MCyR, major cytogenetic response typically defined as ≤ 35% Ph+ chromosomes in metaphase in bone marrow (study definitions may vary); Ph+, Philadelphia chromosome-positive.

From: 3, Clinical effectiveness

Cover of Dasatinib, High-Dose Imatinib and Nilotinib for the Treatment of Imatinib-Resistant Chronic Myeloid Leukaemia: A Systematic Review and Economic Evaluation
Dasatinib, High-Dose Imatinib and Nilotinib for the Treatment of Imatinib-Resistant Chronic Myeloid Leukaemia: A Systematic Review and Economic Evaluation.
Health Technology Assessment, No. 16.23.
Loveman E, Cooper K, Bryant J, et al.
Southampton (UK): NIHR Journals Library; 2012 May.
© 2012, Crown Copyright.

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