Table 2. Comparison of characteristics in the CORAL study and NCIC CTG LY.12 study.
| CORAL STUDY23 | NCIC CTG LY.12 STUDY27 | |
|---|---|---|
| Salvage regimen | (R-)ICE vs. (R-)DHAP | (R-)GDP vs (R-)DHAP |
| Patients number | 396 (ICE 202, DHAP 194) | 619 (GDP 319, DHAP 309) |
| 419 (GDP 216, DHAP 203)* | ||
| Disease | R/R aggressive CD20+ B-cell NHL including DLBCL | R/R aggressive lymphoma including DLBCL |
| Study design | Superiority trial | Non-inferiority trial |
| First randomization | R-ICE vs R-DHAP | R-GDP vs. R-DHAP |
| Second randomization | R maintenance after HDT/ASCT | R maintenance after HDT/ASCT |
| HDT regimen | BEAM | Not defined (mandated by institutional policy) |
| Primary endpoint | Mobilization-adjusted response rate | Response rate by arm after two cycles of treatment |
| Age (y), median (range) | 55 (19-65) | 55.5 (19-74)* |
| Ann Arbor stage III-IV | 240 | 285 (66%)* |
| Elevated LDH | 198 | 188 (44%)* |
| Prior rituximab | 244 | 325 (76%)* |
| Relapse < 12 mon, refractory relapse ≥ 12 mon | 215 | 180, 133* |
| 244 | 116* |
*; diffuse large B-cell lymphoma subset28
HDT, high-dose chemotherapy; LDH, lactate dehydrogenase; R-ICE, rituximab, ifosfamide, calboplatin, and etoposide; R-DHAP, rituximab, dexamethazone, high-dose cytarabine, and cisplatin; R/R, relapsed or refractory; NHL, non-Hodgkin lymphoma; DLBCL, diffuse large B-cell lymphoma; HDT/ASCT, high-dose chemotherapy supported by autologous stem cell support/transplantation; BEAM, BCNU, etoposide, cyclophosphamide, and melphalan; R-GDP, rituximab, gemcitabine, dexamethazone, and cisplatin