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P. Cramer et al.
relapsed/refractory patients (81%) had responded (Table 2). With a 92% ORR for the mixed population at the end of induction staging, the primary endpoint was met (95% confidence interval [95% CI]: 83–98%; P=0.0013 when tested against the null hypothesis of an ORR of 75%). Fifty-nine patients achieved a PR according to IWCLL cri- teria and one had a PR with lymphocytosis; no CR/CRi were documented, but 18 patients with a PR lacked a bone marrow biopsy (18 patients) and/or a CT scan (14 patients) but fulfilled all other criteria for a CR. MRD was assessed in peripheral blood at the final restaging in 62 of
65 patients and nine patients (14%) had achieved MRD "negativity" (<10-4). The MRD "negativity" rate at the final restaging was 18% among patients treated first-line and 8% among the relapsed/refractory patients. Patients with adverse prognostic markers such as del(17p) and unmutat- ed IGHV had lower overall response and MRD negativity rates: the ORR were 75% and 89%, respectively, for patients with these markers, while the MRD negativity rates were 0% and 9%, respectively (Online Supplementary Appendix, Table S2, page 6).
After up to two cycles of the initial debulking treatment
Figure 1. CONSORT diagram. Patients’ flow through the study. pts: patients; AE: adverse event; MRD: minimal residual disease.
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haematologica | 2021; 106(2)