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Table 1 Clinical trials involving BTK inhibitors combined with BCL2 inhibitors 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 Duration of combination Efficacy Reference
Ibrutinib+venetoclax CLARITY EudraCT
2015–003422-14
2 R/R CLL 54 MRD-driven 1-year CR/CRi: 51%
1-year uMRD in PB/BM: 53%/36%
[31]
VISION
NCT03226301
2 R/R CLL 230 1 year 15-month CR: 53%
15-month uMRD in PB/BM: 55%/39%
[33]
NCT02756897 2 TN CLL/SLL (high-risk and older) 80 2 years 1-year uMRD in BM: 56%
2-year uMRD in BM: 66%
3-year PFS/OS: 93%/96%
[34]
CAPTIVATE (PCYC-1142) NCT02910583 2 TN CLL/SLL 164 MRD-driven 1-year uMRD in PB/BM: 75%/68%
3-year PFS: ≥95%
[36]
159 1 year 1-year CR/CRi: 55%
2-year PFS/OS: 95%/98%
[37]
IMPROVE
NCT04754035
2 R/R CLL 38 MRD-driven 2-year uMRD in both PB and BM: 84% [42]
NCT03128879 2 CLL/SLL (high-risk and after ibrutinib therapy) 45 MRD-driven 1-year CR/CRi: 53%
1-year uMRD in BM: 73%
[38]
AIM
NCT02471391
2 R/R and TN MCL 24 Until progression or unacceptable toxicity 16-week CR: 42%
16-week uMRD in BM: 67%
1-year PFS/OS: 75%/79%
[39, 40]
SYMPATICO (PCYC-1143)
NCT03112174
3 R/R MCL 21 (safety run-in period) 2 years 31-month CR: 62%
30-month PFS: 60%
[41]
Zanubrutinib+venetoclax SEQUOIA NCT03336333 3 TN CLL/SLL (high-risk) 80 MRD-driven Ongoing /
Acalabrutinib+venetoclax NCT03946878 2 TN MCL 50 Until progression or unacceptable toxicity Ongoing /
  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, TN treatment-naïve, R/R relapsed/refractory, uMRD undetectable MRD