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A phase II Japanese trial of fludarabine, cyclophosphamide and rituximab for previously untreated chronic lymphocytic leukemia

OBJECTIVE: Fludarabine, cyclophosphamide and rituximab (FCR) is the standard regimen for fit patients with untreated CD20-positive chronic lymphocytic leukemia (CLL). However, this combination is unavailable in Japan because rituximab is not approved for CLL. We investigated the efficacy and safety...

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Autores principales: Izutsu, Koji, Kinoshita, Tomohiro, Takizawa, Jun, Fukuhara, Suguru, Yamamoto, Go, Ohashi, Yasuo, Suzumiya, Junji, Tobinai, Kensei
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7937417/
https://www.ncbi.nlm.nih.gov/pubmed/33244584
http://dx.doi.org/10.1093/jjco/hyaa215
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author Izutsu, Koji
Kinoshita, Tomohiro
Takizawa, Jun
Fukuhara, Suguru
Yamamoto, Go
Ohashi, Yasuo
Suzumiya, Junji
Tobinai, Kensei
author_facet Izutsu, Koji
Kinoshita, Tomohiro
Takizawa, Jun
Fukuhara, Suguru
Yamamoto, Go
Ohashi, Yasuo
Suzumiya, Junji
Tobinai, Kensei
author_sort Izutsu, Koji
collection PubMed
description OBJECTIVE: Fludarabine, cyclophosphamide and rituximab (FCR) is the standard regimen for fit patients with untreated CD20-positive chronic lymphocytic leukemia (CLL). However, this combination is unavailable in Japan because rituximab is not approved for CLL. We investigated the efficacy and safety of FCR in this single-arm, multicenter study designed as a bridging study to the CLL8 study by the German CLL Study Group. METHODS: The study enrolled previously untreated patients with CLL of Binet stage B or C with active disease. Patients with a Cumulative Illness Rating Scale score of ≤6 and creatinine clearance of ≥70 ml/min were eligible. Patients received 6 cycles of FCR every 28 days and were followed for up to 1 year. RESULTS: Seven patients were enrolled. The best overall response rate according to the 1996 NCI-WG Guidelines, the primary endpoint of the study, was 71.4% (95% confidence interval, 29.0–96.3%), with one patient achieving complete response. No deaths or progression occurred during follow-up. The main adverse event was hematotoxicity. CD4-positive T-cell count decreased in all patients; most patients showed no reduction in serum immunoglobulin G. CONCLUSION: Although the number of patients was limited, FCR appears to be effective with manageable toxicity for treatment-naïve fit Japanese patients with CD20-positive CLL. CLINICAL TRIAL NUMBER: JapicCTI-132285.
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spelling pubmed-79374172021-03-11 A phase II Japanese trial of fludarabine, cyclophosphamide and rituximab for previously untreated chronic lymphocytic leukemia Izutsu, Koji Kinoshita, Tomohiro Takizawa, Jun Fukuhara, Suguru Yamamoto, Go Ohashi, Yasuo Suzumiya, Junji Tobinai, Kensei Jpn J Clin Oncol Original Article OBJECTIVE: Fludarabine, cyclophosphamide and rituximab (FCR) is the standard regimen for fit patients with untreated CD20-positive chronic lymphocytic leukemia (CLL). However, this combination is unavailable in Japan because rituximab is not approved for CLL. We investigated the efficacy and safety of FCR in this single-arm, multicenter study designed as a bridging study to the CLL8 study by the German CLL Study Group. METHODS: The study enrolled previously untreated patients with CLL of Binet stage B or C with active disease. Patients with a Cumulative Illness Rating Scale score of ≤6 and creatinine clearance of ≥70 ml/min were eligible. Patients received 6 cycles of FCR every 28 days and were followed for up to 1 year. RESULTS: Seven patients were enrolled. The best overall response rate according to the 1996 NCI-WG Guidelines, the primary endpoint of the study, was 71.4% (95% confidence interval, 29.0–96.3%), with one patient achieving complete response. No deaths or progression occurred during follow-up. The main adverse event was hematotoxicity. CD4-positive T-cell count decreased in all patients; most patients showed no reduction in serum immunoglobulin G. CONCLUSION: Although the number of patients was limited, FCR appears to be effective with manageable toxicity for treatment-naïve fit Japanese patients with CD20-positive CLL. CLINICAL TRIAL NUMBER: JapicCTI-132285. Oxford University Press 2020-11-27 /pmc/articles/PMC7937417/ /pubmed/33244584 http://dx.doi.org/10.1093/jjco/hyaa215 Text en © The Author(s) 2020. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permission@oup.com http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Original Article
Izutsu, Koji
Kinoshita, Tomohiro
Takizawa, Jun
Fukuhara, Suguru
Yamamoto, Go
Ohashi, Yasuo
Suzumiya, Junji
Tobinai, Kensei
A phase II Japanese trial of fludarabine, cyclophosphamide and rituximab for previously untreated chronic lymphocytic leukemia
title A phase II Japanese trial of fludarabine, cyclophosphamide and rituximab for previously untreated chronic lymphocytic leukemia
title_full A phase II Japanese trial of fludarabine, cyclophosphamide and rituximab for previously untreated chronic lymphocytic leukemia
title_fullStr A phase II Japanese trial of fludarabine, cyclophosphamide and rituximab for previously untreated chronic lymphocytic leukemia
title_full_unstemmed A phase II Japanese trial of fludarabine, cyclophosphamide and rituximab for previously untreated chronic lymphocytic leukemia
title_short A phase II Japanese trial of fludarabine, cyclophosphamide and rituximab for previously untreated chronic lymphocytic leukemia
title_sort phase ii japanese trial of fludarabine, cyclophosphamide and rituximab for previously untreated chronic lymphocytic leukemia
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7937417/
https://www.ncbi.nlm.nih.gov/pubmed/33244584
http://dx.doi.org/10.1093/jjco/hyaa215
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