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Table 4 Clinical trials with the combination of lenalidomide and rituximab against FL, DLBCL, and TmL

From: Immunomodulation therapy with lenalidomide in follicular, transformed and diffuse large B cell lymphoma: current data on safety and efficacy

Study

Regimen

Pt

ORR (%)

CR/uCR (%)

PR (%)

Median DR

Median PFS

Median OS

Median F/U

Most common

          

adverse events (grade 3 & 4)*

Untreated FL (not stratified)

Fowler et al. [29, 30]

Len: 20 mg, D1-21

46

98

87

11

N/A

2-yr PFS* 89%

N/A

22 months

Neutropenia (40%)

Rtx: 375 mg/m2, D1

Thrombocytopenia (4%)

Relapsed or refractory FL (not stratified)

Dutia et al. [32]

Len: 20 mg, D1-21

16

86

50

36

N/A

13 months*

N/A

9 months*

Lymphopenia (25%)

Rtx: 375 mg/m2, D15 of C1, 1/wk × 4

Neutropenia (19%)

Hyponatremia (19%)

Wang et al. [34] [only FLG3]

Len: 20 mg, D1-21

4

25

0

25

10.2 months*

2.0 months

25.6 months

24.6 months*

Neutropenia (31% & 22%)

Rtx: 375 mg/m2,

Thrombocytopenia (18% and 16%)

1/wk × 4, only C1

Leonard et al. [33]

Len: 15 mg C1;

45

49

13

36

N/A

EFS 1.2 years

N/A

1.5 years

Neutropenia (16%)

20 mg C2-12, D1-21

Thrombosis (16%)

Fatigue (9%)

Len: 15 mg C1;

44

75

32

43

N/A

EFS 2.0 years

N/A

1.5 years

Neutropenia (19%)

20 mg C2-12, D1-21

Fatigue (14%)

Rtx: 375 mg/m2,, 1/wk × 4

Thrombosis (4%)

Untreated DLBCL

Lenalidomide plus rituximab combination as a front-line therapy has not been studied for untreated DLBCL.

Relapsed or refractory DLBCL

Zinzani et al. [41]

Len: 20 mg, D1-21,

23

35

35

0

N/A

1-yr DFS 34.8%

18-month OS 55%

16 months

Neutropenia (30%)

Rtx: 375 mg/m2, D1-21 (during induction)

Thrombocytopenia (14%)

Wang et al. [34]

Len: 20 mg, D1-21

32

28

22

6

10.2 months*

2.8 months

10.2 months

24.6 months*

Neutropenia (31% & 22%)

Rtx: 375 mg/m2;

Thrombocytopenia (18% and 16%)

1/wk × 4, only C1

Untreated TmL

Lenalidomide plus rituximab combination as a front-line therapy has not been studied for untreated TmL.

Relapsed or refractory TmL

Wang et al. [34]

Len: 20 mg, D1-21

9

56

33

22

10.2 months*

4.3 months

11.5 months

24.6 months*

Neutropenia (31% & 22%)

Rtx: 375 mg/m2.

1/wk × 4, only C1

Thrombocytopenia (18% and 16%)

  1. *Value is for whole study group.
  2. D = day, C = cycle, FL = follicular lymphoma, N/A = data not available, NHL = non-Hodgkin lymphoma, R/R = relapsed or refractory, Len = lenalidomide, Rtx = rituximab, EFS = event-free survival, OS = overall survival, PFS = progression-free survival, DR = duration of response, FL = follicular lymphoma, TmL = transformed lymphoma, CR = complete response, uCR = unconfirmed CR, PR = partial response, ORR = overall response rate, F/U = follow-up period.