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

From: Emerging therapies in mantle cell lymphoma

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 151c [96] 106.8 v NR NPd
Maintenance bortezomib every 2 weeks × 2 years vs observation [104, 105] III 135e [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
  1. 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
  2. aNon-hematologic grade ≥ 3 AE in > 5% of patients
  3. bResponse measured at 100 days post-transplant
  4. cNumber of patients enrolled start of induction, 50 patients were randomized to a twice-weekly schedule and 52 patients to a weekly schedule
  5. 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
  6. e44% of patients initially enrolled went on to randomization
  7. fResponse rate after completing both parts of the treatment. The ORR% after completing ibrutinib + rituximab was 95
  8. gAE reported for the ibrutinib + rituximab part of therapy
  9. *f/up in months