Key clinical point: Addition of ibrutinib to rituximab, ifosfamide, carboplatin, and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, idarubicin, and dexamethasone (RVICI) provided no survival benefit in children and young adults with relapsed or refractory mature B-cell non-Hodgkin lymphoma (B-NHL).
Major finding : Patients receiving ibrutinib plus RICE/RVICI vs RICE/RVICI alone had similar median event-free survival (6.1 vs 7.0 months; hazard ratio [HR] 0.9; P = .387) and median overall survival (14.1 vs 11.1 months; HR 0.9; P = .789). All patients experienced grade ≥3 treatment-emergent adverse events.
Study details: Findings represent the final results of SPARKLE trial Part 2 that included 51 patients aged 1-30 years with relapsed or refractory mature B-NHL who were randomly assigned to receive ibrutinib plus RICE/RVICI (n = 35) or RICE/RVICI alone (n = 16).
Disclosures: This study was funded by Janssen Research and Development. Some authors reported ties with various organizations, including Janssen. Six authors declared being employees of Janssen or holding stocks in Johnson & Johnson.
Source: Burke GAA et al. Ibrutinib plus RICE or RVICI for relapsed/refractory mature B-cell non-Hodgkin lymphoma in children and young adults: SPARKLE trial. Blood Adv. 2023;7(4):602-610 (Feb 20). Doi: 10.1182/bloodadvances.2022008802