|
| References | Regimen | No | Response | TLS | TFR | AE grade 3-4 |
|
Chanan Kh [21]
2007
Phase II
Relapsed or refractory | Lenalidomide 5 mg per day escalating up to 25 mg per day | 45 | ORR 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 | 44 | ORR 32%
RC: 7%
OS 73% at 14 months TFS: NR | 0 | 12% | 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) | 25 | ORR 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) | 31 | ORR 16%
RC 0
PFS responding 16 m versus 6 m | 0 | 53% | 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 toxicity | 60
(>65 years)
median 71 years | ORR 65%
RC 10%
OS 88%
TFS 60%
(estimated at 2 years) | 0 | 52% | 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) | 21 | | 7% | 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) | 60 | ORR 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 mg | 52 | ORR 12%
RC 0%
SD 58% | | 10% | Neutropenia 65%
Thrombocytopenia 33%
Anemia 10% |
|
