Current trials for frontline therapy of mantle cell lymphoma

Table 2 Clinical trials for older patients with MCL

Leading institution	PI last name	Regimen	Study ID/NCT	EE	Phases	Line	Recruitment	First received	Study results	Cytogenetical inclusion criteria	Age group (years)
MDACC	Wang	RLI	2016-0280 NCT03232307	40	II	1st	Not yet rec	07/2572017	NA	Ki-67 ≥ 50% Cycline D1 +	> 65
Acerta Pharma BV	Gupta	BR vs BR-Acalabrutinib	ACE-LY-308 NCT02972840	546	III	1st	Recruiting	11/21/2016	NA	t(11;14) and/or CCND1 overex	≥ 65
MDACC	Wang	IR	2013-0090 NCT01880567	50	II	1st/RR	Recruiting	6/14/2013	Preliminary [33] but no results for UMCL	If UMCL: Ki-67 < 50% Cycline D1 +	> 65 if UMCL ≥ 18 if RRMCL
MDACC	Wang	BR vs I-BR	SHINE NCT01776840	524	III	1st	Active, not rec	1/24/2013	NA	t(11;14) and/or CCND1 overex	≥ 65
FCCC	Smith	4 arms: A. BR → R B. BRV → R C. BR → LR D. BRV → LR	ECOG-E1411 NCT01415752	332	II	1st	Recruiting	8/11/2011	NA	t(11;14) and/or CCND1 overex	≥ 60
LUH	Jerkeman	L-BR	NLG-MCL4 NCT00963534	60	I/II	1st	Active, not rec	8/20/2009	Preliminary [41] CRR 64% mPFS 42 months 3-year OS 73%	Not specified	≥ 65

BR bendamustine rituximab; CCND1 cyclin D1; CRR complete response rate; EE estimated enrollment; FCCC Fox Chase Cancer Center; I-BR ibrutinib bendamustine and rituximab; ID identification; IR ibrutinib-rituximab; L lenalidomide; L-BR lenalidomide bendamustine and rituximab; LR lenalidomide rituximab; LUH Lund University Hospital; MDACC MD Anderson Cancer Center; mPFS median progression-free survival; NA not available; NCT clinical trial number registered at clinicaltrials.gov; OS overall survival; overex overexpression; PI principal investigator; R rituximab; rec recruiting; RLI rituximab, lenalidomide, ibrutinib; RR relapsed and/or refractory; t translocation; UMCL untreated mantle cell lymphoma

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