The Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, with chemoimmunotherapy in patients with chronic lymphocytic leukemia (original) (raw)

The safety and efficacy of ibrutinib, an oral inhibitor of Bruton's tyrosine kinase, were evaluated in combination with chemoimmunotherapy (CIT) in a multicenter, phase 1b study. Patients with relapsed/refractory chronic lymphocytic leukemia received bendamustine and rituximab (BR) or fludarabine, cyclophosphamide, and rituximab (FCR) for up to six 28-day cycles with continuous daily ibrutinib 420 mg until progressive disease or unacceptable toxicity. Enrollment to FCR-ibrutinib closed early due to a lack of fludarabine-naïve previously-treated patients. No patients treated with BR-ibrutinib (n = 30) or FCR-ibrutinib (n = 3) experienced prolonged hematologic toxicity in cycle 1 (primary end point). Tolerability was consistent with that expected from either CIT or single-agent ibrutinib. The objective response rate (ORR) with BR-ibrutinib was 93.3%, including 16.7% complete responses (CRs) initially, that increased to 40.0% with the extension period; including 1 patient with part...

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