Current trials for frontline therapy of mantle cell lymphoma

Table 4 Clinical trials for patients with MCL aged 18 and older

Leading institution	PI last name	Regimen	Study ID/NCTNCT	EE	Phases	Line	Recruitment	First received	Study results	Cytogenetical inclusion criteria	Age (years)
UW	Chang	BG → risk adapted MG	UW16086 NCT03311126	32	II	1st	Recruiting	09/28/2017	NA	CCND1 positive	≥ 18
MDACC	Wang	Ibrutinib in low-risk disease	2016-0914 NCT03282396	30	II	1st	Not yet rec	09/12/2017	NA	CCND1 positive, but no RF*	≥ 18
Acerta Pharma BV	Sim-Wages	Acalabrutinib-BR	ACE-LY-106 NCT02717624	48	Ib	1st and RR	Active, not rec	02/24/2016	NA	Not specified	≥ 18
HCB	Giné	RI with indolent disease	GELTAMO-IMCL-2015 NCT02682641	50	II	1st	Recruiting	1/18/2016	NA	Indolent MCL with Ki-67 ≤ 30%	18–99
MSKCC	Kumar	1. R-R-CHOP 2. R-HIDAC 3. M R-R	15-196 NCT02633137	45	II	1st	Recruiting	12/15/2015	NA	Not specified	≥ 18
NWU	Kaplan	Intensive Induction → MI	NU 14H06 NCT02242097	36	II	1st	Recruiting	9/12/2014	NA	Not specified	≥ 18
MSKCC	Hamlin	Ofatumumab+ − bendamustine	11-050 NCT01437709	30	II	1st	Active, not rec	09/19/2011	NA	Not specified	≥ 18
PSH	Pu	VCR	NCT01439750	50	I/II	1st and relapsed	Active, not rec	8/16/2011	NA	Not specified	≥ 18
GSK	GSK	¹³¹I Tositumomab →CHOP	393229/005 NCT00992992	25	II	1st	Completed	10/8/2009	NA	Not specified	≥ 18
MDACC	Wang	V-R-HyperCVAD/V-R-HD-MTX/AraC	2006-0697 NCT00477412	110	I	1st	Active, not rec	05/21/2007	NA	Diffuse, nodular, blastoid	18–79
NIH	Wilson	EPOCH-R-B → MV vs observation	05-C-0170 NCT00114738	52	II	1st	Active, not rec	6/17/2005	NA	Not specified	18–100
Corixa Corporation	NA	¹³¹I Tositumomab →CHOP	CP-99-037 NCT00022945		II	1st	Completed	8/16/2001	NA	Not specified	≥ 18

BR bendamustine, rituximab; BG bendamustine, obinutuzumab; CCND1 cyclin D1; EPOCH rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin; EE estimated enrollment; GSK GlaxoSmithKline; HCB Hospital Clínic de Barcelona; ID identification; MG maintenance obinutuzumab; M R-R maintenance R-R; MI maintenance ibrutinib; MV bortezomib maintenance; NA not available; NCT clinical trial number registered at clinicaltrials.gov; NIH National Institute of Health; NWU Northwestern University; PI principal investigator; PSH PennState Health Milton S. Hershey Medical Center; R-CHOP rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; rec recruiting; R-EPOCH rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin EPOCH-R-B: R-EPOCH and bortezomib; RF* blastoid variant histology, pleomorphic variant histology, Ki-67 ≥ 50%, high-risk MCL International Prognostic Index (MIPI), bulky tumors > 3 cm, presence of B symptoms; R-HIDAC : rituximab and high-dose cytarabine; RI ibrutinib and rituximab; R-R lenalidomide and rituximab; RR relapsed/refractory; VCR bortezomib, cladribine, and rituximab; V-R-HyperCVAD/V-R-HD-MTX/AraC bortezomib (Velcade) plus rituximab Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate, and Dexamethasone alternating with bortezomib plus rituximab-high-dose methotrexate/cytarabine; UW University of Wisconsin, Madison

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