Table 3 Clinical trials with single-agent lenalidomide (25 mg, days 1–21) against FL, DLBCL, and TmL
Study | No. of patients | ORR | CR/uCR | PR | MDRǂ | PFSǂ | OSǂ | F/Uǂ | Most common |
|---|---|---|---|---|---|---|---|---|---|
adverse events (grade 3 & 4)* | |||||||||
Untreated FLG1/2 | |||||||||
Single agent lenalidomide has not been studied for initial therapy of FLG1/2. | |||||||||
Relapsed or refractory FLG1/2 | |||||||||
NHL-001: | 22 | 27 | 9 | 18 | >16.5* | 4.4* | N/A | 4.4* | Neutropenia (30% & 16%) |
Witzig et al. [9] | |||||||||
Thrombocytopenia (14% & 5%) | |||||||||
Untreated FLG3 | |||||||||
Single agent lenalidomide has not been studied for initial therapy of FLG3. | |||||||||
Relapsed or refractory FLG3 | |||||||||
NHL-002: | 5 | 60 | 0/20 | 40 | 6.2* | 4* | N/A | 3.7* | Neutropenia (24.5% & 8.2%) |
Wiernik et al. [7] | |||||||||
Thrombocytopenia (12.2% & 8.2%) | |||||||||
NHL-003 | 19 | 42 | 11 | 32 | NR | 8.9 | N/A | 9.2* | Neutropenia (41%) |
Witzig et al. [8] | |||||||||
Thrombocytopenia (19%) | |||||||||
Untreated DLBCL | |||||||||
Single agent lenalidomide has not been studied for initial therapy of DLBCL. | |||||||||
Relapsed or refractory DLBCL | |||||||||
NHL-002: | 26 | 19 | 4/8 | 8 | 6.2* | 4* | N/A | 3.7* | Neutropenia (24.5% & 8.2%) |
Wiernik et al. [7] | |||||||||
Thrombocytopenia (12.2% & 8.2%) | |||||||||
NHL-003 | 108 | 28 | 7 | 20 | 4.6 | 2.7 | N/A | 9.2* | Neutropenia (41%) |
Witzig et al. [8] | Thrombocytopenia (19%) | ||||||||
Untreated TmL | |||||||||
Single agent lenalidomide has not been studied for initial therapy of TmL. | |||||||||
Relapsed or refractory TmL | |||||||||
NHL-002: | 3 | 33 | 0 | 33 | 6.2* | 4* | N/A | 3.7* | Neutropenia (24.5% & 8.2%) |
Wiernik et al. [7] | |||||||||
Thrombocytopenia (12.2% & 8.2%) | |||||||||
NHL-003: | 33 | 45 | 21 | 24 | 12.8 | 5.4 | N/A | 9.2* | Neutropenia (41%) |
Witzig et al. [8] | Thrombocytopenia (19%) | ||||||||