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| 1 | Bendamustine treatment of Chinese patients with relapsed indolent non-Hodgkin lymphoma: a multicenter, open-label, single-arm, phase 3 study显示文摘Background:Bendamustine was approved in China on May 26th,2019 by the National Medical Product Administration for the treatment of indolent B-cell non-Hodgkin lymphoma(NHL).The current study was the registration trial and the first reported evaluation of the efficacy,safety,and pharmacokinetics of bendamustine in Chinese adult patients with indolent B-cell NHL following relapse after chemotherapy and rituximab treatment.Methods:This was a prospective,multicenter,open-label,single-arm,phase 3 study(NCT01596621;C18083/3076)with a 2-year follow-up period.Eligible patients received bendamustine hydrochloride 120 mg/m2 infused intravenously on days 1 and 2 of each 21-day treatment cycle for at least six planned cycles(and up to eight cycles).The primary endpoint was the overall response rate(ORR);and secondary endpoints were duration of response(DoR),progression-free survival(PFS),safety,and pharmacokinetics.Patients were classified according to their best overall response after initiation of therapy.Proportions of patients in each response category(complete response[CR],partial response[PR],stable disease,or progressive disease)were summarized along with a twosided binomial exact 95%confidence intervals(CIs)for the ORR.Results:A total of 102 patients were enrolled from 20 centers between August 6th,2012,and June 18th,2015.At the time of the primary analysis,the ORR was 73%(95%CI:63%–81%)per Independent Review Committee(IRC)including 19%CR and 54%PR.With the follow-up period,the median DoR was 16.2 months by IRC and 13.4 months by investigator assessment;the median PFS was 18.6 months and 15.3 months,respectively.The most common non-hematologic adverse events(AEs)were gastrointestinal toxicity,pyrexia,and rash.Grade 3/4 neutropenia was reported in 76%of patients.Serious AEs were reported in 29 patients and five patients died during the study.Pharmacokinetic analysis indicated that the characteristics of bendamustine and its metabolites M3 and M4 were generally consistent with those reported for other ethnicities.Conclusion:Bendamustine is an active and effective therapy in Chinese patients with relapsed,indolent B-cell NHL,with a comparable risk/benefit relationship to that reported in North American patients. | Yuan-Kai Shi Xiao-Nan Hong Jian-Liang Yang Wei Xu Hui-Qiang Huang Xiu-Bin Xiao Jun Zhu Dao-Bin Zhou Xiao-Hong Han Jian-Qiu Wu Ming-Zhi Zhang Jie Jin Xiao-Yan Ke Wei Li De-Pei Wu Shen-Miao Yang Xin Du Yong-Qian Jia Ai-Chun Liu Dai-Hong Liu Zhi-Xiang Shen Lian-Sheng Zhang Leonard James Edward Hellriegel | 2021 | Chinese Medical Journal2021，，11： | 2 |
| 2 | Study on the chiral recognition of the enantiomers of ephedrine derivatives with neutral and sulfated heptakis(2,3-O-diacetyl)-β-cyclodextrins using capillary electrophoresis, UV, nuclear magnetic resonance spectroscopy and mass spectrometry显示文摘 | Hellriegel C Wedig M Steinhauer S | 2001 | J Chromatogr A2001，914，： | 1 |
| 3 | Sperm survival in the female reproductive tract in the fly Scathophaga stercoraria(L)显示文摘 | BERNASCONI G HELLRIEGEL B HEYLAND A | 2002 | J Insect Physiol2002，48，： | 1 |
| 4 | Congruence between Individual Needs,Organizational Climate,Job Satisfaction and Performance显示文摘 | Downey H K Hellriegel D Slocum J W Jr | | 0，，： | 1 |
| 5 | A genome-wide survey of RAS transformation targets显示文摘 | Zuber J Tchernitsa O I Hinzmann B Schmitz A C Grips M Hellriegel M | 2000 | Nat Genet2000，24，： | 1 |
| 6 | Gonadotropin-releasing hormone (GnRH) agonist triptorelin inhibits estradiol-induced serum response element (SRE) activation and c-fos expression in human endometrial,ovarian and breast cancer cells显示文摘 | Grundker C Gtinthert A R Hellriegel M Emons G | 2004 | Eur J Endocrinol2004，151，： | 1 |
| 7 | Gonadotropin-releasing hormone (GnRH) agonist triptorelin inhibits estradiol-induced serum response element (SRE) activation and c-fos expression in human endometrial,ovarian and breast cancer cells显示文摘 | Grundker C Gunthert AR Hellriegel M Emons G | 2004 | Eur J Endocrinol2004，151，： | 1 |
| 8 | Treatment of patients with essential tremor显示文摘 | DEUSCHL G RAETHJEN J HELLRIEGEL H | 2011 | Lancet Neurol2011，10，： | 1 |
| 9 | Effect of modafinil at steady state on the single-dose pharmacokinetic profile of warfarin in healthy volunteers显示文摘 | ROBERTSON P Jr HELLRIEGEL ET ARORA S | 2002 | J Clin Pharmacol2002，42，2： | 1 |
| 10 | Effect of modafinil on the pharmacokineties of ethinyl estradiol and triazolam in healthy volunteers显示文摘 | ROBERTSON P Jr HELLRIEGEL ET ARORA S | 2002 | Clin Pharmacol Ther2002，71，1： | 1 |
| 11 | Tracking of single molecules as a powerful method to characterize diffusivity of organic species in mesoporous materials 显示文摘 | CHRISTIAN HELLRIEGEL KIRSTEIN J BRAUCHLE C | 2005 | New Journal of Physics2005，23，7： | 1 |
| 12 | Treat- ment of patients with essential tremor 显示文摘 | DEUSCHL G RAETHJEN J HELLRIEGEL H | 2011 | Lancet Neurol2011，10，2： | 1 |
| 13 | Method deve- lopment in quantitative NMR towards metrologically traceable organic certified reference materials used as 31p qNMR standards 显示文摘 | Weber M Hellriegel C Rueck A | 2015 | Anal Bioanal Chem2015，407，11： | 1 |
| 14 | Mathematical modelling: a tool for hospital infection control 显示文摘 | Grundmann H Hellriegel B | 2006 | Lancet Infect Dis2006，6，1： | 1 |
| 15 | Critical contingencies in joint venture management : Some lessons from managers 显示文摘 | Hill R C Hellriegel D | 1994 | Organization Science1994，5，4： | 1 |
| 16 | Organizational climate: Measures, research and contingencies显示文摘 | Hellriegel Slocurn | 1974 | Academy of Management Journal1974，17，2： | 1 |
| 17 | Critical contingencies in joint venture managements: Some lessons from managers显示文摘 | Hill R C and Hellriegel D | 1994 | Organization Science1994，5，： | 1 |
| 18 | Real-time multi-parameter spectroscopy and localization in three-dimensional single-particle tracking显示文摘 | HELLRIEGEL C GRATTON E | 2009 | J R Soc Interface2009，，6： | 1 |
| 19 | Clinical pharmacokinelic profile of modafinil显示文摘 | ROBERTSON P Jr HELLRIEGEL ET | 2003 | Clin Pharmacokinet2003，42，2： | 1 |
| 20 | Gonadotropin- releasing hormone(GnRH) agonist triptorelin inhibits estra-diol- induced serum response element (SRE) activation and c-los expression in human endometrial, ovarian and breast cancer cells 显示文摘 | Grtindker C Gtinthert AR Hellriegel M et ol | 2004 | Eur J Endocrinol2004，151，5： | 1 |
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