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International Journal of Hematology

, Volume 110, Issue 1, pp 77–85 | Cite as

Combined rituximab, bendamustine, and dexamethasone chemotherapy for relapsed or refractory indolent B-cell non-Hodgkin lymphoma and mantle cell lymphoma: a multicenter phase II study

  • Yosuke MatsumotoEmail author
  • Tsutomu Kobayashi
  • Yuji Shimura
  • Eri Kawata
  • Hisao Nagoshi
  • Muneo Ohshiro
  • Mio Sugitani
  • Kazuho Shimura
  • Toshiki Iwai
  • Shin-ichi Fuchida
  • Mihoko Yoshida
  • Miki Kiyota
  • Shinsuke Mizutani
  • Yoshiaki Chinen
  • Tomoko Takimoto-Shimomura
  • Mitsushige Nakao
  • Hiroto Kaneko
  • Hitoji Uchiyama
  • Nobuhiko Uoshima
  • Hikari Nishigaki
  • Yutaka Kobayashi
  • Shigeo Horiike
  • Chihiro Shimazaki
  • Masafumi Taniwaki
  • Junya Kuroda
  • Kyoto Clinical Hematology Study Group (KOTOSG)
Original Article
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Abstract

This multicenter phase II study (UMIN000008145) aims to investigate the efficacy and safety of six cycles of combination therapy (RBD) comprising rituximab, bendamustine, and dexamethasone (DEX) for relapsed or refractory (RR) indolent B-cell non-Hodgkin lymphoma (B-NHL) and mantle cell lymphoma (MCL). Although the initial study protocol comprised 20 mg/body DEX on days 1 and 2, and 10 mg/body on days 3–5 [high-dose (HD-) DEX group], the dose of DEX was later decreased to 8 mg/body on days 1 and 2 [low-dose (LD-) DEX group] due to frequent cytomegalovirus (CMV) antigenemia and recurrent retinitis. We enrolled 33 patients, and LD-DEX and HD-DEX were administered in 15 and 18 patients, respectively. The overall response and the 3-year progression-free survival rates were 88% and 75.5%, respectively. The leading adverse event was myelosuppression. Incidence of grade 3–4 leukocytopenia, neutropenia, and lymphocytopenia was 55%, 67%, and 91%, respectively. The most frequent nonhematological adverse events were CMV antigenemia and rash (33% and 30%, respectively). Incidence of CMV antigenemia over 10/100,000 white blood cells was significantly lower with LD-DEX than that with HD-DEX (P = 0.0127). In conclusion, RBD showed significant effectiveness for RR indolent B-NHL and MCL.

Keywords

Rituximab Bendamustine Dexamethasone Indolent B-cell non-Hodgkin lymphoma Mantle cell lymphoma 

Notes

Compliance with ethical standards

Conflict of interest

Junya Kuroda received grants from Eisai Co., Ltd. and Chugai Pharmaceutical Co., Ltd., and Masafumi Taniwaki received grant from Chugai Pharmaceutical Co., Ltd. The remaining authors have no conflict of interest.

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Copyright information

© Japanese Society of Hematology 2019

Authors and Affiliations

  • Yosuke Matsumoto
    • 1
    • 2
    Email author
  • Tsutomu Kobayashi
    • 3
  • Yuji Shimura
    • 3
  • Eri Kawata
    • 3
    • 4
  • Hisao Nagoshi
    • 5
  • Muneo Ohshiro
    • 1
  • Mio Sugitani
    • 6
  • Kazuho Shimura
    • 2
  • Toshiki Iwai
    • 1
  • Shin-ichi Fuchida
    • 7
  • Mihoko Yoshida
    • 2
  • Miki Kiyota
    • 6
  • Shinsuke Mizutani
    • 3
  • Yoshiaki Chinen
    • 3
  • Tomoko Takimoto-Shimomura
    • 3
  • Mitsushige Nakao
    • 8
  • Hiroto Kaneko
    • 2
  • Hitoji Uchiyama
    • 1
  • Nobuhiko Uoshima
    • 4
  • Hikari Nishigaki
    • 9
  • Yutaka Kobayashi
    • 4
  • Shigeo Horiike
    • 3
  • Chihiro Shimazaki
    • 7
  • Masafumi Taniwaki
    • 2
    • 10
  • Junya Kuroda
    • 3
  • Kyoto Clinical Hematology Study Group (KOTOSG)
  1. 1.Department of HematologyJapanese Red Cross Kyoto Daiichi HospitalKyotoJapan
  2. 2.Departments of Hematology and Laboratory MedicineAiseikai Yamashina HospitalKyotoJapan
  3. 3.Division of Hematology and OncologyKyoto Prefectural University of MedicineKyotoJapan
  4. 4.Department of HematologyJapanese Red Cross Kyoto Daini HospitalKyotoJapan
  5. 5.Department of Hematology and OncologyHiroshima UniversityHiroshimaJapan
  6. 6.Department of HematologyMatsushita Memorial HospitalMoriguchiJapan
  7. 7.Department of Hematology, Japan Community Health care OrganizationKyoto Kuramaguchi Medical CenterKyotoJapan
  8. 8.Department of HematologyOtsu City HospitalOtsuJapan
  9. 9.Department of HematologyFukuchiyama City HospitalFukuchiyamaJapan
  10. 10.Center for Molecular Diagnostics and TherapeuticsKyoto Prefectural University of MedicineKyotoJapan

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