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Table 1 Clinical trials with pathway inhibitors in CLL

From: Critical molecular pathways in CLL therapy

Agent

N

Age in years

Median follow-up in months (Range)

TP53/

CK

ORR

PFS (2y)

OS (2y)

Ref.

(Study)

(R/R-TN)

(Range)

d17p

(CR)

(median in months)

(median in months)

Ibrutinib

132

68

46

34

41

86%

n.r.

n.r.

(O'Brien et al., 2016)

(NCT01105247/NCT01109069)

(101-31)

(37-84)

(0-67)

(14%)

(not reached)

(not reached)

Ibrutinib + rituximab

40

65

47

21

15/28

95%

62%

78%

(Jain et al., 2017)

(36-4)

(35-82)

(36-51)

(23%)

(45mo)

(not reached)

Ibrutinib

84

n.r.

34

53

n.r.

n.r.

84% at 3y

n.r.

(Ahn et al., 2017)

(NCT01500733)

(32-52)

(0.1-50)

 

(not reach)

Ibrutinib

144

64

28

144

n.r.

83%

63%

75%

(O'Brien et al., 2016)

(NCT01744691)

(144-0)

(n.r.)

(n.r.)

(n.r.)

(not reached)

(not reached)

Ibrutinib +/- rituximab +/- bendamustine

88

66

28

34/40

21/56

94%

n.a.

n.r.

(Thompson et al., 2015)

(88-0)

(35-83)

(14-48)

(17%)

Ibrutinib

195

67

19

79/154

39/153

90%

74%

86% at 1.5y

(Brown et al., 2018)

(NCT01578707)

(195-0)

(30-86)

(n.r.-26)

 

(n.r.)

(n.r.)

Ibrutinib

621

60

17

26%

73/216

n.r.

64%

79%

(Mato et al., 2016)

Connect® CLL Registry

(536-80)

(22-95)

(n.r.)

 

(35mo)

(not reached)

Ibrutinib

315

69

16

90/263

n.a.

n.r.

74% at 1y

84% at 1y

(Forum, 2016)

UK CLL Forum

(315-0)

(42-93)

(n.r.)

 

(n.r.)

(n.r.)

Ibrutinib

95

69

10

50/80

n.a.

84%

75% at 1y

82% at 1y

(Winqvist et al., 2016)

Swedish CUP

(94-1)

(42-86)

(n.r.)

(3%)

(not reached)

(not reached)

Idelalisib

54

63

n.r.

13

n.a.

72%

n.r.

n.r.

(Brown et al., 2014)

(NCT00710528)

(54-0)

(37-82)

 

(16mo)

(not reach)

Idelalisib + rituximab

110

71

13

46

n.a.

81%

38%

72%

(Furman et al., 2014)

(NCT01539512)

(110-0)

(48-90)

(n.r.)

(0%)

(19mo)

(not reached)

 

Idelalisib + ofatumumab

174

68

16

70

n.a.

75%

≈30%

≈65%

(Jones et al., 2017)

(NCT01659021)

(174-0)

(61-74)

(n.r.)

(<1%)

(16mo)

(not reached)

Idelalisib + bendamustine

207

62

14

69

n.a.

n.r.

48%

75%

(Zelenetz et al., 2017)

(NCT01569295)

(207-0)

(56-69)

(n.r.)

 

(21mo)

(not reached)

Venetoclax

116

66

17

31

n.a.

79%

52%

84%

(Roberts et al., 2016)

(NCT01328626)

(116-0)

(36-86)

(1-26)

(20%)

(25 mo)

(not reached)

Venetoclax + rituximab

49

68

28

10/32

n.a.

86%

82%

94%

(Seymour et al., 2017)

(NCT01682616)

(49-0)

(50-88)

(1-42)

(51%)

(not reached)

(not reached)

Venetoclax

107

67

12

107

n.a.

79%

72% at 1y

87% at 1y

(Stilgenbauer et al., 2016)

(NCT01889186)

(107-0)

(37-85)

(n.r.)

(16%)

(not reached)

(not reached)

  1. R/R Relapsed/Refractory, TN Treatment Naive, CK Complex Karyotype, n.r. No reported, n.a. No applicable, mo Months, y Year