1. Rituximab biosimilar RTXM83 versus reference rituximab in combination with CHOP as first-line treatment for diffuse large B-cell lymphoma: a randomized, double-blind study
- Author
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Kaplanov, K. D., ÖZCAN, MEHMET ALİ, Udovitsa, D. P., Ilyin, N., Alekseev, S. M., Fadjari, H., Arumugan, V., Chakrabarti, P., Kirushnakumar, K. S., Attili, A. V. S. Suresh, Dantas da Cunha Junior, A., Schmidt Filho, J., Franke, F. A., Sampaio Tavares, R., Pinto Simoes, B., Miguel, C. E., Meton, F., Boquimpani, C., Schaffel, R., Cigno, E. L., Basso, A. C., Jarchum, G., Heller, V. B., Bullorsky, E., Furque, M. L., Jones, L., Bassa, F., Osmanov, D. S., Burdaeva, O. N., Melnichenko, V. Y., Uy, N. A., Keat, C. Teng, Rosales, J. D., Galvez, K., Lazaretti, N., Debiasi, M., Santi, P. Xavier, de Mattos, E. R., Luiz da Silva, R., Rodrigues de Oliveira, J. S., Pereira, J., Salvino de Araujo, A., Fogliatto, L., Beguelin, G. Z., Saslavsky, M. M., Munoz, M., Avila, G. I., Moiseevich, M. G., Viktorovich, P. A., Tiangco, B. J., Molina Barrios, G. R., Martinez-Lapus, F. G. P., Villegas, E. M., Raman, R., Gin, G. Gin, Bermudez, C., Ciliao Munhoz, E., Garcia, J. J., De Stefano, G., Caffaro, J., Syafei, S., da Silva Araujo, S. Shusterschitz, Kowalyszyn, R. D., Jasuja, S., Bhurani, D., Radhakrishnan, V., Salvatierra, A., Mukhopadhyay, A., Bhattacharyya, S., Bhatt, N., Perez Diaz, Luis, Paravisini, Alexandra, Fogliatto, Laura, Nodehi, Sayyed Reza Safaee, Patel, Moosa, Volodicheva, Elena Mikhailovna, Lipatov, Oleg Nikolaevich, Guan, Toh See, Querol, John, Flores, David Hugo, Dasappa, Lokanatha, Beniwal, Surender Kumar, Bar, Daniel Oscar, Delamain, Marcia Torresan, Gonzalez, Derlis E., Candelaria, Myrna, Florez, A., Michiels, S., Leao, D., Loggetto, S. R., Szpak, W., Lifirenko, I. D., Ponomarev, R. S., Lysenko, I. B., and Vladimirov, V.
- Subjects
Adult ,Male ,Cancer Research ,medicine.medical_specialty ,Adolescent ,CHOP ,Gastroenterology ,law.invention ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Randomized controlled trial ,Double-Blind Method ,immune system diseases ,law ,hemic and lymphatic diseases ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Adverse effect ,Biosimilar Pharmaceuticals ,Cyclophosphamide ,Aged ,business.industry ,Immunogenicity ,Hematology ,Middle Aged ,medicine.disease ,Prognosis ,Lymphoma ,Survival Rate ,Oncology ,Doxorubicin ,Vincristine ,030220 oncology & carcinogenesis ,Pharmacodynamics ,Prednisone ,Rituximab ,Female ,Lymphoma, Large B-Cell, Diffuse ,business ,Diffuse large B-cell lymphoma ,030215 immunology ,medicine.drug ,Follow-Up Studies - Abstract
This multicenter, double-blind, randomized study compared the efficacy, pharmacokinetics (PKs)/pharmacodynamics (PDs), safety and immunogenicity profile of RTXM83 vs. reference rituximab (R-rituximab), both with CHOP, as first-line treatment of diffuse large B-cell lymphoma (DLBCL). A total of 272 patients
- Published
- 2019