Randomized phase II study of a bendamustine monotherapy schedule for relapsed or refractory low-grade B-cell non-Hodgkin lymphoma or mantle cell lymphoma (RABBIT-14)

Abstract

The aim of this randomized phase II study was to improve the treatment delays and discontinuations associated with bendamustine use by comparing the effect of Benda-14 (intravenous bendamustine, 120 mg/m² on days 1 and 15, repeated every 4 weeks for a total of 6 cycles) with those of the standard treatment in relapsed indolent lymphoma and/or mantle cell lymphoma. Forty-six patients were randomly assigned to the treatments from September 2012 to February 2016. Treatment accomplishment rate and median relative dose intensity were similar in both arms: 38 and 63.4% in the Benda-14 arm and 41 and 66.3% in the standard treatment arm, respectively. The overall response rate and median progression-free survival, respectively, were 83% and 21.0 months for Benda-14, and 77% and 15.5 months for the standard treatment. Benda-14 induced favorable responses with less frequent hematological toxicities.

Keywords:

• Bendamustine
• randomized phase II study
• non-Hodgkin lymphoma
• mantle cell lymphoma

Acknowledgments

We are grateful to Dr. Toshiyuki Takagi (Oami Municipal Hospital, Oamishirasato, Japan) and Dr. Masahiro Kisaki (Saitama Medical Center, Kawagoe, Japan) for their advice, which was helpful in the study. We are also grateful to Dr. Makoto Kashimura (Matsudo Municipal Hospital, Matsudo, Japan), Dr. Kyoya Kumagai (Division of Medical Oncology, Chiba Cancer Center, Chiba, Japan), and Dr. Kaichi Nishiwaki (Division of Hematology/Oncology, Kashiwa Hospital, The Jikei University, Kashiwa, Japan) for their advice on the development of the study protocol. We thank Ms. E. Yamagishi (Advanced Clinical Research Organization, Tokyo, Japan) for her assistance in the management of our data. Finally, we thank the Shimousa Hematology study group, doctors, nurses, and patients who participated in this multicenter trial for their excellent cooperation.

Potential conflict of interest

Disclosure forms provided by the authors are available with the full text of this article online at https://doi.org/10.1080/10428194.2017.1390233.