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Table 2 Clinical trials involving BTK inhibitors combined with BCL2 inhibitors and anti-CD20 monoclonal antibodies in treating CLL and MCL

From: Combining BTK inhibitors with BCL2 inhibitors for treating chronic lymphocytic leukemia and mantle cell lymphoma

Combination Trial Phase Patients Sample size Efficacy Reference
Ibrutinib+venetoclax+obinutuzumab NCT02427451 2 TN and R/R CLL 50 uMRD in both PB and BM: 56% (TN) and 44% (R/R)
3-year PFS: 95% in both cohorts
3-year OS: 95% (TN) and 100% (R/R)
[51]
CLL2-GIVe
NCT02758665
2 TN CLL (high-risk) 41 15-month CR: 58.5%
15-month uMRD in PB/BM: 78% /65.9%
2-year PFS/OS: 95.1%/95.1%
[52]
OAsIs
NCT02558816
1/2 TN and R/R MCL 48 6-month CR: 67% (R/R) and 86.6% (TN)
2-year PFS and OS rates (R/R): 69.5 and 68.6%
1-year PFS (TN): 93.3%
[53]
Acalabrutinib+venetoclax+obinutuzumab NCT03580928 2 TN CLL 44 16-month CR/CRi: 43%
16-month uMRD in PB/BM: 84%/78%
[54]
Acalabrutinib+venetoclax+obinutuzumab or rituximab CL-003
NCT02296918
1b TN and R/R CLL/SLL 24 16-month CR/CRi: 50% in both cohorts
10-month uMRD in PB: 67% (R/R) and 75% (TN)
18-month PFS/OS: 100%/100% in both cohorts
[55]
Acalabrutinib+venetoclax+rituximab NCT02717624 1b TN MCL 21 6-month CR/PR: 90%/10%
1-year PFS/OS: 89%/95%
6-month uMRD in PB: 75%
[56]
Zanubrutinib+venetoclax+obinutuzumab NCT03824483 2 TN CLL/SLL 39 26-month uMRD in PB/BM: 95%/89% [57]
NCT03824483 2 TN MCL (TP53mut) 25 Ongoing [58]
  1. BM bone marrow, CLL/SLL chronic lymphocytic leukemia/small lymphocytic lymphoma, CR complete remission, CRi CR with incomplete count recovery, MCL mantel cell lymphoma, MRD minimal residual disease, OS overall survival, PB peripheral blood, PFS progression-free survival, R/R relapsed/refractory, TN treatment-naïve, TP53mut TP53 mutant, uMRD undetectable MRD