Phase I study of brentuximab vedotin (SGN-35) in Japanese children with relapsed or refractory CD30-positive Hodgkin’s lymphoma or systemic anaplastic large cell lymphoma
- 20 January 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in International Journal of Hematology
- Vol. 111 (5), 711-718
- https://doi.org/10.1007/s12185-020-02820-1
Abstract
Data on the treatment of pediatric patients with brentuximab vedotin are limited. The aims of the present study were to assess the safety and tolerability of brentuximab vedotin in Japanese children with relapsed or refractory Hodgkin’s lymphoma (HL) or systemic anaplastic large-cell lymphoma (sALCL). Pediatric patients, aged 2–17 years, with relapsed or refractory HL or sALCL were recruited. Brentuximab vedotin were administered at 1.8 mg/kg via intravenous infusion once every 3 weeks. Primary endpoints were dose-limiting toxicity and safety. Between September 2016, and March 2018, six patients (median age 11.5, range 5–14 years), four with relapsed or refractory HL and two with relapsed or refractory sALCL were enrolled. Dose limiting toxicity was not observed in any of the six patients. Although three of six patients (50%) experienced at least one grade ≥ 3 adverse event, no patient experienced a serious adverse event. The pharmacokinetic profile of brentuximab vedotin in pediatric patients was comparable to that reported in adults. The proportion of patients who achieved overall response was 60% (95% confidence interval 14.7–94.7). Brentuximab vedotin at 1.8 mg/kg once every 3 weeks was considered tolerable in children with relapsed or refractory HL or sALCL.Keywords
Funding Information
- the Japan Agency for Medical Research and Development via Center for Clinical Trials Japan Medical Association (CCT-B-2703)
This publication has 11 references indexed in Scilit:
- Phase I clinical study of brentuximab vedotin (SGN-35) involving children with recurrent or refractory CD30-positive Hodgkin’s lymphoma or systemic anaplastic large cell lymphoma: rationale, design and methods of BV-HLALCL study: study protocolBMC Cancer, 2018
- Phase I / II study of brentuximab vedotin in Japanese patients with relapsed or refractory CD30‐positive Hodgkin's lymphoma or systemic anaplastic large‐cell lymphomaCancer Science, 2014
- Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma: Results of a Phase II StudyJournal of Clinical Oncology, 2012
- Brentuximab Vedotin (SGN-35) for Relapsed CD30-Positive LymphomasThe New England Journal of Medicine, 2010
- Single-Drug Vinblastine As Salvage Treatment for Refractory or Relapsed Anaplastic Large-Cell Lymphoma: A Report From the French Society of Pediatric OncologyJournal of Clinical Oncology, 2009
- Impact of the Methotrexate Administration Dose on the Need for Intrathecal Treatment in Children and Adolescents With Anaplastic Large-Cell Lymphoma: Results of a Randomized Trial of the EICNHL GroupJournal of Clinical Oncology, 2009
- High-dose chemotherapy and autologous stem cell transplantation for Hodgkin's lymphoma in the kingdom of Saudi Arabia: King Faisal specialist hospital and research center experienceBone Marrow Transplantation, 2008
- Allogeneic haematopoietic stem cell transplantation in relapsed or refractory anaplastic large cell lymphoma of children and adolescents – a Berlin–Frankfurt–Münster group reportBritish Journal of Haematology, 2006
- Recurrent childhood anaplastic large cell lymphoma: a retrospective analysis of registered cases in JapanBritish Journal of Haematology, 2006
- High-Dose Therapy and Autologous Hematopoietic Stem-Cell Transplantation for Recurrent or Refractory Pediatric Hodgkin's Disease: Results and Prognostic IndicesJournal of Clinical Oncology, 2004