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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