Table 1: Lenalidomide monotherapy trials in patients with CLL.

ReferencesRegimenNoResponseTLSTFRAE grade 3-4

Chanan Kh [21]
2007
Phase II
Relapsed or refractory
Lenalidomide 5 mg per day escalating up to 25 mg per day45ORR 47%
RC 9%
OS: NR
TFS: NR
5%58%Neutropenia 70%
Thrombocytopenia 45%
Anemia 18%

Ferrajoli [7]
2008
Phase II
Relapsed or refractory
Lenalidomide 10 mg per day escalating up to 25 mg/day (5 mg each 28 days)
Median 10 mg
44ORR 32%
RC: 7%
OS 73% at 14 months TFS: NR
012%Neutropenia 41%
Thrombocytopenia 13%
Anemia 3%

Chen [9, 25]
2011
Phase II
Untreated
Lenalidomide 2.5 mg per week escalating up to 10 mg or 25 mg if no response
Median 18 cycles (2–33)
25ORR 72%
OS 85.3%
TFS 68.8%
(estimated at 3 years)
0 88%Neutropenia 76%
Thrombocytopenia 28%
Anemia 20%

Aue 2010 [10]
Phase II
Relapsed or refractory
Lenalidomide pulses: 10–20 mg for 21 days followed by 21 days of rest (4–8 cycles)31ORR 16%
RC 0
PFS responding 16 m versus 6 m
053%Neutropenia 56%
Thrombocytopenia 30%
Anemia 15%
Infection

Badoux [26]
2011
Phase II
Elderly
Untreated
Lenalidomide 5 mg monthly increases to 25 mg as tolerated until disease progression or unacceptable toxicity60
(>65 years)
median 71 years
ORR 65%
RC 10%
OS 88%
TFS 60%
(estimated at 2 years)
052%Neutropenia 83%
Thrombocytopenia 47%
Anemia <1%
Infection 10%

Lamanna [27]
Phase II
Treated and untreated
Continuous low dose 2.5 mg to 5 mg is increased if progression (up to 20 mg)217%47%Neutropenia 52%
Thrombocytopenia 24%

Wendter [28]
CLL-009
2011
Phase II
Relapsed or refractory
Initial doses of 5, 10, or 15 mg escalating up to 25 mg (dose finding)60ORR 37%
RC 3.4%
3.4%10%Neutropenia 41,7%
Thrombocytopenia 25%
Anemia 8.3%

Wendter [22]
2012
CLL-001
Phase II
Treated
Continuous cycles of 28 days increasing from 2.5 mg to 25 mg52ORR 12%
RC 0%
SD 58%
10%Neutropenia 65%
Thrombocytopenia 33%
Anemia 10%

TLS: tumor lysis syndrome; TFR: tumor flare reaction; AE: adverse effects; NR: not reported; ORR: overall response; CR: complete remission; OS: overall survival; SD: stable disease; TFS: treatment-free survival; m: months.