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Table 4 Treatment exposure and dose modifications

From: Phase IB part of LOC-R01, a LOC network non-comparative randomized phase IB/II study testing R-MPV in combination with escalating doses of lenalidomide or ibrutinib for newly diagnosed primary central nervous system lymphoma (PCNSL) patients

 

Lenalidomide

Ibrutinib

 

Dose K,

N = 7

Dose K-1,

N = 6

Overall,

N = 13

Dose K,

N = 5

Dose K + 1,

N = 7

Overall,

N = 12

Mean relative dose intensity, % (SD)

Lenalidomide

Ibrutinib

Rituximab

Methotrexate

Procarbazine

Vincristine

77.2 (33)

NA

98.5 (3.2)

82.8 (17.9)

83.8 (32.5)

61.6 (19.2)

95.6 (12.3)

NA

95.4 (6.1)

93.1 (6.5)

94.1 (9.9)

82.8 (27.5)

85.7 (26.4)

NA

97.1 (4.8)

87.5 (14.4)

88.5 (24.5)

71.4 (24.9)

NA

84.8 (7.1)

99.8 (1.2)

99.2 (0.9)

98 (8.1)

87.5 (28.0)

NA

92 (7.5)

99.1 (2.1)

97.1 (6.5)

104.4 (6.7)

90.5 (20.1)

NA

89 (7.9)

99.4 (1.8)

97.9 (4.9)

101.7 (7.7)

89.3 (22.5)

Dose delay because of an AE, N (%)

≥ 3 days

≥ 7 days

3 (42.9)

3 (42.9)

4 (66.7)

3 (50)

7 (53.8)

6 (46.2)

2 (40)

1 (20)

5 (71.4)

3 (42.9)

7 (58.3)

4 (33.3)

Dose reduction because of an AE, N (%)

Lenalidomide

Ibrutinib

Rituximab

Methotrexate

Procarbazine

Vincristine

3 (42.9)

NA

0 (0)

4 (57.1)

1 (14.43)

6 (85.7)

2 (33.3)

NA

0 (0)

0 (0)

0 (0)

2 (33.3)

5 (38.5)

NA

0 (0)

4 (30.8)

1 (7.7)

8 (61.5)

NA

3 (60)

1 (20)

0 (0)

1 (20)

1 (20)

NA

3 (42.9)

0 (0)

1 (14.3)

0 (0)

2 (28.6)

NA

6 (50)

1 (8.3)

1 (8.3)

1 (8.3)

3 (25)

  1. The mean relative dose intensity was calculated as the total received dose divided by the total expected dose, in average of the 4 cycles per patient. Dose delays and reductions were considered if occurring in at least one of the four induction cycles. For rituximab and procarbazine, doses were often rounded because of bottle/tablet management. SD: standard deviation; NA: not applicable; AE: adverse event