期刊
CANCER CHEMOTHERAPY AND PHARMACOLOGY
卷 90, 期 1, 页码 83-95出版社
SPRINGER
DOI: 10.1007/s00280-022-04442-2
关键词
Bendamustine; Rapid infusion; Non-Hodgkin lymphoma; Phase I; II; Safety; Tolerability
资金
- SymBio Pharmaceuticals Limited
- Sanofi
- Novartis
- AbbVie
- Bayer
- Takeda Pharmaceutical Company
- Celgene
- Ono Pharmaceutical
- Chugai Pharmaceutical
- Eisai
- IQVIA
- SRD
- MSD K.K
- Otsuka Pharmaceutical
- Micron
- Janssen
- Kyowa Hakko Kirin
- Zenyaku Kogyo
- Incyte
- Mundipharma
- ADC
- AstraZeneca
- Bristol-Myers Squibb
- Daiichi-Sankyo
- Genmab
- HUYA
- Meiji Seika Pharma
- Nippon Shinyaku
- Pfizer
- Solasia
- Stemline
- Dainippon Sumitomo Pharma
- Yakult
- Astellas Pharma
- Amgen
- Takeda
- Teijin Pharma
- National Hospital Organization
- Chordia
- Bristol-Myers
- Minophagen
- JIMRO
- Otsuka Medical Device
- Celltrion Healthcare
- Verastem
- DenovoBiopharma
This study aimed to evaluate the safety and efficacy of bendamustine in different types of lymphoma patients. The results showed that bendamustine is safe, well-tolerated, and effective for previously untreated iNHL, MCL, or rrDLBCL patients.
Purpose This phase I/II clinical study was conducted to examine the safety, tolerability, pharmacokinetics, and efficacy of 10-min dosing of bendamustine in patients with previously untreated indolent B-cell non-Hodgkin lymphoma (iNHL) or mantle cell lymphoma (MCL) (Group 1) and patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) (Group 2). Methods Rituximab 375 mg/m(2) was administered intravenously every 28 days to Group 1 patients on day 1 and every 21 days to Group 2 patients on day 1. Bendamustine 90 mg/m(2)/day was administered to the former on days 1 and 2; bendamustine 120 mg/m(2)/day was administered to the latter on days 2 and 3. Each regimen was delivered up to six cycles for both groups. The primary endpoints were safety and tolerability in Groups 1 and 2, respectively. Results Among 37 enrolled patients, safety was assessed in 36. In Group 1 (n = 30), 27 patients (90%) had follicular lymphoma. Adverse events (AEs) were observed in all 30 patients in Group 1. Dose-limiting toxicities were observed in two of six patients in Group 2. Common AEs included lymphocyte count decreased (86.7%, 100%). In Group 1, overall response and complete response rates were 93.1% (95% confidence interval [CI] 77.2-99.2%) and 75.9% (95% CI 56.5-89.7%), respectively. The C-max and AUC of bendamustine tended to be higher in Group 2 than in Group 1. Conclusions This study showed that bendamustine is safe, well-tolerated and effective for patients with previously untreated iNHL, MCL or rrDLBCL. Pharmacokinetic data were equivalent to those obtained outside of Japan. Registration numbers Registration NCT03900377; registered April 3, 2019.
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