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Therapy of Advanced-stage Mature B-cell Lymphoma and Leukemia in Children and Adolescents With Rituximab and Reduced Intensity Induction Chemotherapy (B-NHL 2004M Protocol): The Results of a Multicenter Study

Samochatova, Elena V. MD, PhD; Maschan, Alexey A. MD, PhD; Shelikhova, Larisa N. MD; Myakova, Natalia V. MD; Belogurova, Margarita B. MD, PhD; Khlebnikova, Olga P. MD; Shamardina, Anastasia V. MD; Ryskal, Olga V. MD; Roumiantseva, Julia V. MD; Konovalov, Dmitriy M. MD; Dubrovina, Maria E. MD; Rumyantsev, Alexander G. MD, PhD

Journal of Pediatric Hematology/Oncology: July 2014 - Volume 36 - Issue 5 - p 395–401
doi: 10.1097/MPH.0b013e31829d4900
Clinical and Laboratory Observations

Pediatric mature B-cell non-Hodgkin lymphomas (B-NHLs) are highly aggressive malignant tumors that are curable with chemotherapy (ChT). High-dose methotrexate (MTX) is considered indispensable for successful treatment, but this therapy frequently induces severe mucositis and infectious complications, especially in induction, which can cause treatment failure. A prospective multicenter trial of combined immunochemotherapy for advanced-stage B-NHL with rituximab and the modified NHL-BFM-90 protocol was conducted. The major differences from the original protocol were a decrease in the dose of MTX from 5000 to 1000 mg/m2/24 h in the first 2 ChT blocks and the addition of rituximab at 375 mg/m2 to each of the first 4 blocks of ChT. Eighty-three newly diagnosed patients with a median age of 8.84 years with Burkitt lymphoma/leukemia and diffuse large B-cell lymphomas stage III to IV were included. Four patients died during induction ChT due to tumor lysis syndrome and infection. Two additional patients died subsequently due to tumor resistance. Complete remission was achieved in 77 (92.8%) patients; 2 patients relapsed at 1 and 3 months, and 2 developed secondary malignancies at 1 and 6.5 years, respectively, after the completion of therapy. The overall survival probability was 82%±8% with a median follow-up of 65.2 months. Combined therapy with rituximab and intensive ChT with a reduced MTX dose of 1 g/m2 in the 2 induction courses was feasible and produced high cure rates in patients with pediatric advanced-stage mature B-NHL.

*Federal Research Centre of Pediatric Hematology, Oncology and Immunology named after Dmitry Rogachev

Russian Pediatric Clinical Hospital, Moscow

Municipal Clinical Hospital No. 31, Saint-Petersburg

§Regional Pediatric Clinical Hospital, Yekaterinburg

Regional Pediatric Clinical Hospital, Nizhniy Novgorod

Territorial Pediatric Clinical Hospital, Perm, Russia

The authors declare no conflict of interest.

Reprints: Elena V. Samochatova, MD, PhD, Federal Research Center for Pediatric Hematology, Oncology and Immunology, Samora Machel str. 1 Moscow, 117198, Russia (e-mail:

Received November 15, 2012

Accepted April 22, 2013

Copyright © 2014 Wolters Kluwer Health, Inc. All rights reserved.