Table 1.
Selected clinical trials using lenalidomide alone for treatment of CLL. NR: not reported.
| Study | Regimen | No. of patients | TLS all grades | TFR all grades | Hematologic side effects grade 3/4 | OR (%) | CR (%) | OS (%) | PFS (%) |
|---|---|---|---|---|---|---|---|---|---|
| Chanan-Khanet al. [14] Phase II relapsed/refractory CLL |
5 mg/d escalated to 25 mg/d | 45 | 5% | 58% | Neutropenia 70% thrombocytopenia 45% anemia 18% | 47 | 9 | NR | NR |
|
| |||||||||
| Ferrajoli et al. [6] Phase II relapsed/refractory CLL |
10 mg/d escalated to 25 mg/d | 44 | 0 | 12% | Neutropenia 41% thrombocytopenia 15% anemia 3% | 32 | 7 | 73 (with a median follow-up time of 14 months) | NR |
|
| |||||||||
| Chen et al. [16] Phase II untreated CLL |
2.5 mg/descalated to 10 mg/d | 25 | 0 | 88% | Neutropenia 72% thrombocytopenia 28% anemia 20% | 56 | 0 | 92 (estimated 2 years OS) | 89 (estimated 2 years PFS) |
|
| |||||||||
| Aue et al. [17] Phase II relapsed/refractory CLL |
20 mg/d lowered to 10 mg/d | 33 | 0 | 53% | Neutropenia 56% thrombocytopenia 30% anemia 15% | NR | NR | NR | NR |
|
| |||||||||
| Badoux et al. [18] phase II (elderly) untreated CLL |
5 mg/d escalated to 25 mg/d | 60 | 0 | 52% | Neutropenia 34% thrombocytopenia 12% anemia <1% | 65 | 10 | 88 (estimated 2 years OS) | 60 (estimated 2 years PFS) |