Emerging therapies in mantle cell lymphoma

Table 2 Investigative combination treatments for relapsed/refractory MCL

Combination therapy	NCT#/publication	Phase	Sample size [median f/u^*]	Median lines of prior therapy	ORR% [CR%]	Median PFS (months)	Grade ≥ 3 (%)^a
Ibrutinib/rituximab	NCT01880567 [75]	II	50 [16.5]	3	88 [44]	NR	A.fib (12), renal and urinary disorder (6)
Ibrutinib/ venetoclax	NCT02471391 [76, 77]	II	23 [37.5]	2	71 [62]	29	Diarrhea (12), soft tissue infection (8), lower respiratory tract infection (8) TLS (8), a.fib (8)
Ibrutinib/ venetoclax	NCT03112174	III	ongoing
Obinutuzumab/ibrutinib	NCT02558816 [78]	I	9 [23.5]	1	87 [87]	NR	none
Obinutuzumab/ibrutinib/ venetoclax	NCT02558816 [78]	I	12 [6.5]	2	66.6 [25]	NR	none
Lenalidomide/rituximab	NCT00294632 [79]	II	44 [23.1]	2	57 [36]	11.1	Fatigue (14), non-neutropenic infection (7), hypercalcemia (7), hyperuricemia (7)
Lenalidomide/rituximab^b	NCT00783367 [80]	II	11 [39.2]	3	55 [55]	24.4	Hypokalemia (10), hypophosphatemia (6)
Lenalidomide/obinutuzumab	NCT01582776	II	13 [14.5]	2	46.2 [15.4]	NP	Infections (12.5)
Ibrutinib/lenalidomide/ rituximab	NCT02460276 [81]	II	50 [17.8]	2	76 [56]	16	Infections (26), rash (14), GI (12), vascular (10)
Palbociclib/ibrutinib	NCT02159755 [82]	I	27 [25.6]	1	67 [37]	NP	Hypertension (15), febrile neutropenia (15), lung infection (11), URI (7), fatigue (7), transaminitis (7) rash (7)
Palbociclib/ibrutinib	NCT03478514	II	ongoing

Abbreviations: NR not reached, NP not presented, ORR overall response rate, CR complete response, PFS progression-free survival, A.fib atrial fibrillation
^aNon-hematologic grade ≥ 3 AE in > 5% of patients
^bRituximab refractory
*Median f/up in months

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