干旱区生态环境知识资源中心(Arid): Ibrutinib, obinutuzumab, and venetoclax in relapsed and untreated patients with mantle cell lymphoma: a phase 1/2 trial

Arid

DOI	10.1182/blood.2020008727
	Ibrutinib, obinutuzumab, and venetoclax in relapsed and untreated patients with mantle cell lymphoma: a phase 1/2 trial
	Le Gouill, Steven; Morschhauser, Franck; Chiron, David; Bouabdallah, Krimo; Cartron, Guillaume; Casasnovas, Olivier; Bodet-Milin, Caroline; Ragot, Sylviane; Bossard, Celine; Nadal, Nathalie; Herbaux, Charles; Tessoulin, Benoit; Tchernonog, Emmanuelle; Rossi, Cedric; McCulloch, Rory; Gastinne, Thomas; Callanan, Mary B.; Rule, Simon
通讯作者	Le Gouill, S (corresponding author), Univ Nantes, Ctr Hosp Univ CHU Nantes, INSERM Ctr Rech Cancerol & Immunol Nantes Angers, Serv Hematol Clin,Nantes Excellence Trajectory Ne, Nantes, France. ; Le Gouill, S (corresponding author), Univ Hosp Hotel Dieu, F-44093 Nantes 01, France.
来源期刊	BLOOD
ISSN	0006-4971
EISSN	1528-0020
出版年	2021
卷号	137 期号:7 页码:877-887
英文摘要	Ibrutinib, obinutuzumab, and venetoclax demonstrate synergy in preclinical models of mantle cell lymphoma (MCL). OAsIs (NCT02558816), a single-arm multicenter prospective phase 1/2 trial, aimed to determine the maximum tolerated dose of venetoclax in combination with fixed doses of ibrutinib and obinutuzumab, in relapsed MCL patients. At the venetoclax MTD, extension cohorts were opened for relapsed and untreated patients. Safety and efficacy were secondary objectives. Minimal residual disease (MRD) was assessed by allele-specific oligonucleotide quantitative polymerase chain reaction. Between 14 October 2015 and 29 May 2018, 48 patients were enrolled. No dose-limiting toxicity was reported, and venetoclax at 400 mg per day was chosen for extension. Eighteen (75%) relapsed and 8 (53%) untreated patients experienced grade 3/4 adverse events. The complete response rate assessed by positron emission tomography at the end of cycle 6 was 67% in relapsed and 86.6% in untreated patients. MRD clearance for evaluable patients was seen in 71.5% of relapsed (10/14 patients) and 100% of untreated MRD-evaluable patients (n 5 12) at the end of 3 cycles. The median follow-up for relapsed patients was 17 months (range, 10-35 months). The 2-year progression-free survival (PFS) was 69.5% (95% confidence interval [CI], 52.9%-91.4%) and 68.6% (95% CI, 49.5%-95.1%) for overall survival. The median follow-up was 14 months (range, 5-19) for untreated patients, the 1-year PFS was 93.3% (95% CI, 81.5%-100%). The combination of obinutuzumab, ibrutinib, and venetoclax is well tolerated and provides high response rates, including at the molecular level, in relapsed and untreatedMCL patients.
类型	Article
语种	英语
收录类别	SCI-E
WOS记录号	WOS:000646082000010
WOS关键词	CONTINUAL REASSESSMENT METHOD ; OVERCOME ; RESISTANCE ; BTK
WOS类目	Hematology
WOS研究方向	Hematology
资源类型	期刊论文
条目标识符	http://119.78.100.177/qdio/handle/2XILL650/349724
作者单位	[Le Gouill, Steven; Tessoulin, Benoit] Univ Nantes, Ctr Hosp Univ CHU Nantes, INSERM Ctr Rech Cancerol & Immunol Nantes Angers, Serv Hematol Clin,Nantes Excellence Trajectory Ne, Nantes, France; [Morschhauser, Franck] Univ Lille, CHU Lille, Lille, France; [Chiron, David] Univ Nantes, CNRS, INSERM, Nantes, France; [Bouabdallah, Krimo] CHU Bordeaux, Bordeaux, France; [Cartron, Guillaume] Univ Montpellier, Inst Genet Mol Montpellier, INSERM, CHU Montpellier, Montpellier, France; [Casasnovas, Olivier; Nadal, Nathalie; Rossi, Cedric] CHU Dijon, INSERM, Dijon, France; [Bodet-Milin, Caroline] Univ Nantes, Serv Med Nucl CHU Nantes, INSERM CRCINA Nantes Angers, NeXT, Nantes, France; [Ragot, Sylviane; Callanan, Mary B.] Univ Bourgogne, CHU Dijon, INSERM, Fac Med, Dijon, France; [Bossard, Celine] CHU Nantes, Serv Anatomopathol, Nantes, France; [Herbaux, Charles] CHU Lille, Lille, France; [Tchernonog, Emmanuelle] CHU Montpellier, Montpellier, France; [McCulloch, Rory; Rule, Simon] Univ Plymouth, Peninsula Med Sch, Pl...
推荐引用方式 GB/T 7714	Le Gouill, Steven,Morschhauser, Franck,Chiron, David,et al. Ibrutinib, obinutuzumab, and venetoclax in relapsed and untreated patients with mantle cell lymphoma: a phase 1/2 trial[J],2021,137(7):877-887.
APA	Le Gouill, Steven.,Morschhauser, Franck.,Chiron, David.,Bouabdallah, Krimo.,Cartron, Guillaume.,...&Rule, Simon.(2021).Ibrutinib, obinutuzumab, and venetoclax in relapsed and untreated patients with mantle cell lymphoma: a phase 1/2 trial.BLOOD,137(7),877-887.
MLA	Le Gouill, Steven,et al."Ibrutinib, obinutuzumab, and venetoclax in relapsed and untreated patients with mantle cell lymphoma: a phase 1/2 trial".BLOOD 137.7(2021):877-887.