Table 3.
Name of the protocol | R2-CHOP [56] | LR-CHOP21 [57] | R2-CHOP [58] | |
Year of publication | 2011 | 2010 | 2011 | |
| ||||
Type of study | Monocentric | Multicentric-IIL | Multicentric | |
Phase | Phase I | Phase I-II | Phase I-II | |
Treatment | Lenalidomide and R-CHOP21 | Lenalidomide and R-CHOP21 | LenalidomideandR-CHOP21 | |
Dose of lenalidomide: | 15 to 25 mg/d, D1–10 | 5 to 20 mg/d, D1–14 | 5 to 25 mg/d, D1–14 | |
every 21 days | every 21 days | every 21 days | ||
No. of cycles | 6 | 6 | 6 | |
No. of patients with DLBCL |
24 | 21 | 27 | |
Recommended dose in function of DLT |
25 mg | 15 mg | 25 mg | |
Toxicity | ||||
Hematologic | Grade III-IV | Grade III-IV | Grade III-IV | |
Anemia | 21% | 4% | — | |
Neutropenia | 88% | 28% | 59% | |
Thrombocytopenia | 29% | 10% | 30% | |
Grade III | Grade III | Grade I-II | Grade III | |
Peripheral neurotoxicity | 8% | 14% | 48% | 0% |
Vascular thrombosis | 8% | 7% | ||
Response | ||||
ORR n, (%) | 22 (87.5) | 16 (72) | 27 (100) | |
CR n, (%) | 18 (77) | 15 (71) | 20 (74) | |
PR n, (%) | 1 (5) | 7 (26) | ||
Stable disease n, (%) | — | |||
Progression n, (%) | 5 (21) | 5 (16) | — |
R-CHOP: rituximab 375 mg/m2 D1, cyclophosphamide 750 mg/m2 D1, doxorubicin 50 mg/m2 D1, vincristine 1.4 mg/m2 D1 (capped at 2.0 mg) prednisone 50 mg/m2 D1–5.
DTL: dose limiting toxicity.