Emerging therapies in mantle cell lymphoma

Table 4 Investigative front line treatments for the newly diagnosed transplant eligible MCL patients

Therapy	NCT#/publication	Phase	Sample size [follow-up^*]	ORR% [CR%]	Median PFS	Grade ≥ 3 (%)^a
R-HyperCVAD+ bortezomib	[101]	II	95 [44]	100 [82]	55	Neutropenic fever (9)
v-BEAM	[102]	I/II	23 [58.5]	95 [86]^b	NR	Neutropenic fever (59), anorexia (21), peripheral neuropathy (19), orthostatic hypotension (16), ileus (9)
Maintenance bortezomib days 1, 4, 8, 11 of 21 days × 4 cycles vs. maintenance bortezomib weekly for 4 weeks on /4 weeks off × 9 cycles	NCT00310037 [103]	III	151^c [96]	–	106.8 v NR	NP^d
Maintenance bortezomib every 2 weeks × 2 years vs observation	[104, 105]	III	135^e [77.5]	–	NR v NR	Infections (7)
Lenalidomide + R-CHOP → R-HIDAC → R2	NCT02633137	II	ongoing
Maintenance R2 vs rituximab	NCT02354313	III	ongoing
R2	NCT01472562 [106, 107]	II	38 [64]	92 [64]	NR	Infections (19.4), tumor flare (11), abdominal pain (5), serum sickness (5), syncope (5), neutropenic fever (5)
(R-CHOP/R-DHAP → auto-HCT) vs (R-CHOP/R-DHAP + ibrutinib → auto-HCT → ibrutinib) vs (R-CHOP/R-DHAP + ibrutinib → ibrutinib)	NCT02858258 [108]	III	ongoing
Acalabrutinib + BR/R-HiDAC → auto-HCT	NCT03623373	II	ongoing
Ibrutinib + Rituximab → R-hyperCVAD	NCT02427620 [109]	II	131 [22]	100 [94]^f	NR	Fatigue (8), myalgia (8), rash (8)^g

Abbreviations: NR not reached, NP not presented, ORR overall response rate, CR complete response, PFS progression-free survival, auto-HCT autologous hematopoietic cell transplantation, R2 lenalidomide (Revlimid) and rituximab
^aNon-hematologic grade ≥ 3 AE in > 5% of patients
^bResponse measured at 100 days post-transplant
^cNumber of patients enrolled start of induction, 50 patients were randomized to a twice-weekly schedule and 52 patients to a weekly schedule
^dSpecific toxicities were not presented, but 19 patients withdrew from the study due to AE (28% of patients in a twice-weekly schedule and 13% in the weekly schedule) including 4 treatment-related deaths
^e44% of patients initially enrolled went on to randomization
^fResponse rate after completing both parts of the treatment. The ORR% after completing ibrutinib + rituximab was 95
^gAE reported for the ibrutinib + rituximab part of therapy
*f/up in months

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