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

From: Emerging therapies in mantle cell lymphoma

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 NCT02558816b [85] I 15 [NP] 100 [47] NP Hepatobiliary disorder (27), rash (7)
Acalabrutinib + rituximab + (bendamustine or venetoclax) NCT02717624 I ongoing    
  1. 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 
  2. 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
  3. bStep C of the OAsIs trial
  4. *f/up in months