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Table 2 Investigative combination treatments for relapsed/refractory MCL

From: Emerging therapies in mantle cell lymphoma

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