SPIRIT3 support includes Biobanking : broadly as for SPIRIT2, but plus genomic DNA (mouth wash via kit) Correlative Science: B iomarkers LSC biology NGS: mutation analysis : hypothesis generation. Example: Imatinib Metabolism. St John’s Wort carbamazepine phenytoin. CYP3A4/5.
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SPIRIT3 support includesBiobanking: broadly as for SPIRIT2, but plus genomic DNA (mouth wash via kit)Correlative Science: BiomarkersLSC biologyNGS: mutation analysis: hypothesis generation
Example: Imatinib Metabolism
St John’s Wort
(t½ = 40hrs)
(t½ = 18hrs)
1A1, 1B1, 1A2,
2D6, 2C9, 2C19
n = 77
Mantel-Cox Log Rank Test (p values)
n = 88
n = 17
n = 11
p < 0.000
Davies et al 2012, EHA Amsterdam (abstract)
Nilotinib 300 mg BID (n = 282)
Nilotinib 400 mg BID (n = 281)
Imatinib 400 mg QD (n = 283)
* Stratification by Sokal risk score.
10 years of follow-up are planned
Primary endpoint = MMR at 12 months. This is superior in nilotinib recipients (either dose) compared with imatinib (P < .0001; Saglio et al NEJM 2010).
Kantarjian HM, et al. Blood. 2012;120(21):[abstract 1676].
LVEF, left ventricular ejection fraction.
Data cutoff: 27Jul2011.
cerebrovascular events: 18 24 4
Data cutoff: 27Jul 2012.