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Ibrutinib plus RICE or RVICI for relapsed/refractory mature B-cell non-Hodgkin lymphoma in children and young adults: SPARKLE trial
GAA. Burke, L. Vinti, E. Kabickova, A. Beishuizen, N. Tacyildiz, A. Uyttebroeck, HJ. Kang, F. Luisi, V. Minard-Colin, B. Burkhardt, M. Tamegnon, S. Sun, M. Curtis, S. Deshpande, K. Nottage, A. Howes, S. Srinivasan, D. Bhojwani, R. Norris, M. Cairo
Jazyk angličtina Země Spojené státy americké
Typ dokumentu randomizované kontrolované studie, časopisecké články, práce podpořená grantem
NLK
Directory of Open Access Journals
od 2016
PubMed Central
od 2016
Europe PubMed Central
od 2016
ROAD: Directory of Open Access Scholarly Resources
od 2016
- MeSH
- difúzní velkobuněčný B-lymfom * MeSH
- dítě MeSH
- etoposid MeSH
- ifosfamid * MeSH
- karboplatina MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- rituximab MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
Part 1 results of the open-label, randomized, global phase 3 SPARKLE trial supported continued assessment of ibrutinib with either modified rituximab, ifosfamide, carboplatin, and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, idarubicin, and dexamethasone (RVICI) in pediatric patients with relapsed/refractory (R/R) mature B-cell non-Hodgkin lymphoma (B-NHL). We report final results of Part 2 evaluating the efficacy of ibrutinib plus RICE or RVICI vs RICE/RVICI alone. Patients aged 1 to 30 years (initial diagnosis <18 years) were randomized 2:1 to receive ibrutinib with or without RICE/RVICI. Primary endpoint was event-free survival (EFS) based on independent committee-confirmed events. Fifty-one patients were enrolled. Median age was 15 years; Burkitt lymphoma, Burkitt leukemia, and Burkitt-like lymphoma (total: 45%) and diffuse large B-cell lymphoma/primary mediastinal B-cell lymphoma (51%) were the most common subtypes. At the preplanned interim analysis, median EFS was 6.1 vs 7.0 months with ibrutinib plus RICE/RVICI vs RICE/RVICI, respectively (hazard ratio, 0.9; 90% confidence interval, 0.5-1.6; P = .387); further enrollment was ceased. With ibrutinib plus RICE/RVICI vs RICE/RVICI, median overall survival was 14.1 vs 11.1 months, overall response rate was 69% vs 81%, and 46% vs 44% proceeded to stem cell transplantation. In both treatment arms, 100% of patients experienced grade ≥3 treatment-emergent adverse events. No EFS benefit was seen with ibrutinib. Salvage was generally poor in patients who received prior rituximab, regardless of treatment arm. No new safety signals were observed. Ibrutinib exposure in pediatric patients fell within the target range of exposure in adults. Trial is registered on www.clinicaltrials.gov (NCT02703272).
Cancer and Blood Disease Institute Children's Hospital Los Angeles Los Angeles CA
Clinical Biostats Janssen Research and Development Raritan NJ
Clinical Oncology Janssen Research and Development High Wycombe United Kingdom
Clinical Oncology Janssen Research and Development Raritan NJ
Department of Hemato Oncology Princess Máxima Center for Pediatric Oncology Utrecht The Netherlands
Department of Oncology KU Leuven Leuven Belgium
Department of Pediatric Hematology and Oncology Ankara University Cebeci Hospital Ankara Turkey
Department of Pediatric Hematology and Oncology University Hospitals Leuven Leuven Belgium
Oncology Translational Research Janssen Research and Development Lower Gwynedd Township PA
Pediatric Hematology and Oncology University Hospital Münster Münster Germany
Citace poskytuje Crossref.org
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