Table 4.

Phase II and III trials in newly diagnosed MCL

Study type	Therapy	N	Median OS	Median PFS	ORR (%)	CR/CRu (%)	PR (%)
Phase III21 (LYM-3002)	R-CHOP vs VR-CAP	244 vs 243	56.3 m vs NR	14.4 m vs 24.7 m*	89 vs 92	42 vs 53*	–
Phase II53	V	13	–	–	46.2	0	46.2
Phase II58	VR-CHOP	36	86% at 2 y	23 m	81	64	–
Phase II62	VcR-CVAD with ASCT or MR	30	86% at 3 y	63% at 3 y	90	70	13
Phase II64	VcR-CVAD with MR	75	88% at 3 y	72% at 3 y	95	68	–
Phase II65	RiPAD + C	39	NR	26 m	79	59
Phase II66 (S0601)	VR-CHOP followed by 2-year	65	85% at 2 y	62% at 2 y	–	–	–
	V maintenance

Note:

^*P<0.05.

Abbreviations: CAP, cyclophosphamide, doxorubicin, prednisone; CHOP, cyclophosphamide, doxorubicin, vincristine, prednisone; CR, complete response; CRu, complete response unconfirmed; CVAD, cyclophosphamide, vincristine, doxorubicin, dexamethasone; m, months; MR, maintenance rituximab; N, evaluable patients; NR, not reached; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; R, rituximab; RiPAD + C, rituximab, bortezomib, doxorubicin, dexamethasone, cyclophosphamide; V, bortezomib; VR or VcR-bortezomib, rituximab; y, years.