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Clinical Trial
. 2024 Apr;112(4):585-593.
doi: 10.1111/ejh.14148. Epub 2023 Dec 19.

Rituximab with standard LMB chemotherapy in pediatric high-risk mature B-cell non-Hodgkin lymphoma: A report from the JPLSG B-NHL14 trial

Tetsuya Mori  1 , Tomoo Osumi  2 , Akiko Kada  3 , Kentaro Ohki  4 , Yuhki Koga  5 , Reiji Fukano  6 , Naoto Fujita  7 , Tetsuo Mitsui  8 , Takeshi Mori  9 , Akiko M Saito  3 , Atsuko Nakazawa  10 , Ryoji Kobayashi  11 , Masahiro Sekimizu  12
Affiliations
Clinical Trial

Rituximab with standard LMB chemotherapy in pediatric high-risk mature B-cell non-Hodgkin lymphoma: A report from the JPLSG B-NHL14 trial

Tetsuya Mori et al. Eur J Haematol. 2024 Apr.

Abstract

Background: The benefit of adding rituximab to standard lymphomes malins B (LMB) chemotherapy for children with high-risk mature B-cell non-Hodgkin lymphoma (B-NHL) has previously been demonstrated in an international randomized phase III trial, to which the Japanese Pediatric Leukemia/Lymphoma Study Group could not participate.

Methods: To evaluate the efficacy and safety of rituximab in combination with LMB chemotherapy in Japanese patients, we conducted a single-arm multicenter trial.

Results: In this study, 45 patients were enrolled between April 2016 and September 2018. A total of 33 (73.3%), 5 (11.1%), and 6 (13.3%) patients had Burkitt lymphoma/leukemia, diffuse large B-cell lymphoma, and aggressive mature B-NHL, not otherwise specified, respectively. Ten (22.2%) and 21 (46.7%) patients had central nervous system disease and leukemic disease, respectively. The median follow-up period was 47.5 months. Three-year event-free survival and overall survival were 97.7% (95% confidence interval, 84.9-99.7) and 100%, respectively. The only event was relapse, which occurred in a patient with diffuse large B-cell lymphoma. Seven patients (15.6%) developed Grade 4 or higher non-hematologic adverse events. Febrile neutropenia was the most frequent Grade 3 or higher adverse event after the pre-phase treatment, with a frequency of 54.5%.

Conclusion: The efficacy and safety of rituximab in combination with LMB chemotherapy in children with high-risk mature B-NHL was observed in Japan.

Keywords: Burkitt lymphoma; children; diffuse large B-cell lymphoma; high-risk; mature B-NHL; rituximab.

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References

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