Ibrutinib + chemoimmunotherapy (CIT) for relapsed/refractory mature B-cell non-Hodgkin lymphoma (B-NHL) in children (SPARKLE trial): Initial safety, PK, and efficacy
Hematological Oncology Jun 19, 2019
Burke A, et al. - Since ibrutinib (ibr), a BTK inhibitor indicated for adult B-cell malignancies, has shown significant preclinical activity in Burkitt lymphoma (BL), researchers reported outcomes from the run-in phase of an ongoing phase 3 trial of ibr + CIT in pediatric relapsed/refractory (R/R) mature B-non-Hodgkin lymphoma (NHL), as well as evaluated the safety and effectiveness of ibr + rituximab, ifosfamide, carboplatin, etoposide (RICE), and dexamethasone (D) or R, vincristine, idarubicin, C, I (RVICI), and D CIT vs CIT alone in pediatric R/R mature B-NHL. Findings revealed that all patients had ≥ 1 treatment-emergent adverse event grade ≥ 3, with hematologic, gastrointestinal, and infectious events being most common. In this poor prognosis pediatric population, continued assessment of ibr + RICE/RVICI was supported. In the combination regimens, safety is consistent with known profiles of the drugs. Part 2 is ongoing, evaluating the effectiveness of the combination with ibr at 440 mg/m2 and 329 mg/m2 in patients aged < 12 and ≥ 12 yrs, respectively.
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