Emerging therapies in mantle cell lymphoma

Table 5 Investigative front line treatment for the newly diagnosed transplant-ineligible MCL patients

Therapy	NCT#/publication	Phase	Sample size [follow-up^*]	ORR% [CR%]	Median PFS (mos)	Grade ≥ 3 (%)
BR + lenalidomide → lenalidomide	NCT00963534 [113]	I/II	51 [31]	80 [64]	42	Infection (42), rash (18), allergic reaction (12), mucositis (6), musculoskeletal pain (6), anorexia (6)
(R-CHOP/R-HAD X 4 vs R-CHOP X 8) ≥ (R2 vs rituximab)	NCT01865110	III	Ongoing
(BR vs BR + bortezomib) → (R2 vs rituximab)	NCT01415752	II	Ongoing
(BR + ibrutinib → rituximab + ibrutinib)	NCT01776840	III	Ongoing
BR + acalabrutinib vs BR	NCT02972840	III	Ongoing
BR + venetoclax	NCT03834688	II	Ongoing
Bendamustine/obinutuzumab/venetoclax	NCT03872180	II	Ongoing
Ibrutinib + rituximab	NCT01880567	II	49 [28]	98 [60]	NR	Myalgias (14), fatigue (14), dyspnea (10), a.fib (8)
R2	NCT01472562 [106, 107]	II	38 [64]^a	92 [64]	NR	Infections (19.4), tumor flare (11), abdominal pain (5), serum sickness (5), syncope (5), neutropenic fever (5)
Acalabrutinib + R2	NCT03863184	II	ongoing
Venetoclax + ibrutinib + obinutuzumab	NCT02558816^b [85]	I	15 [NP]	100 [47]	NP	Hepatobiliary disorder (27), rash (7)
Acalabrutinib + rituximab + (bendamustine or venetoclax)	NCT02717624	I	ongoing

Abbreviations: NR not reached, NP not presented, ORR overall response rate, CRR complete response, PFS progression-free survival, A.fib atrial fibrillation, R2 lenalidomide (Revlimid) and rituximab, R-HAD rituximab, cytarabine, dexamethasone
^aResults are for both younger patients with low and intermediate MIPI scores and older patients with all MIPI scores; results for specific for older patients were not presented
^bStep C of the OAsIs trial
*f/up in months