Outcomes in CD20+ precursor B-ALL treated with chemoimmunotherapy
| Parameter . | R-GMALL study (N = 181) . | Thomas et al study (N = 97) . | GRAALL-R study (N = 105) . | Our study (N = 34) . |
|---|---|---|---|---|
| Median age (range), y | NA (15-55) | 41 (13-83) | 40 (25-51) | 20 (15-52) |
| CNS positivity | NA | 16% | 7% | 29% |
| Chemotherapy, backbone and additional drug | GMALL with rituximab (comparator-GMALL chemotherapy) | Modified hyper-CVAD with rituximab (comparator-modified hyper-CVAD) | GRAALL-2005 regimen with rituximab (comparator-GRALL-2005 chemotherapy) | BFM-90 with rituximab and bortezomib (historical cohort treated with modified BFM-90 alone as comparator) |
| Total no. of rituximab infusions in induction | 1 | 2 | 2 | 5 |
| Total no. of rituximab infusions | 8 (induction and consolidation) | 12 (induction, intensification, and maintenance) | 16-18 All phases of treatment | 5 |
| Postinduction CR rate | 94% 81% in high-risk group (comparator arm- 91% in standard-risk and 88% in high-risk) | 92%-100% based on use of intensification (comparator arm, 94%) | 90% (89% in comparator arm) | 85.3% (70% in historical cohort) |
| Postinduction MRD level <10−4; evaluable patients/total) | 57% in standard-risk; Not reported (comparator arm- 27% in standard risk; Not reported); not reported for high-risk | 81% (at CR); 57/97 (compared with CD20– subset, 58%) | 65%; 49/105 (comparator arm- 61%; 36/104) | 70.9%; 31/34 (51.7%; 85/89 in historical cohort) |
| Day of bone marrow EOI MRD assessment | Day 24 | Day 21 | Day 29 | Day 29 |
| Post-consolidation MRD level <10−4 | 90% | NA | 91% | Postinduction plus consolidation, 87.5% |
| Consolidation time point | Week 16 | NA | Weeks 12-14 | Week 16 |
| MRD detection method | NA | Four-color MFC-sensitivity <1 × 10−4 | Multiplex real-time quantitative PCR Sensitivity at least 10−4 | 10-color MFC sensitivity 1 in 10−6 |
| Early death | 7% | NA | 7% | 3% |
| CR duration (%) | 5-year CRD, 80% | 3-year CRD, 67% | NA | 21-month CRD, 93.6% |
| 2-year EFS | NA | NA | 65% | Estimated 2-year EFS, 71.4% |
| OS (%) | 5 years, 71% | 3 years, 61% | 71% | Estimated 2-year OS, 71.4% |
| Grade 3/4 neuropathy | NA | NA | 4% (4/105) | 0 |
| Parameter . | R-GMALL study (N = 181) . | Thomas et al study (N = 97) . | GRAALL-R study (N = 105) . | Our study (N = 34) . |
|---|---|---|---|---|
| Median age (range), y | NA (15-55) | 41 (13-83) | 40 (25-51) | 20 (15-52) |
| CNS positivity | NA | 16% | 7% | 29% |
| Chemotherapy, backbone and additional drug | GMALL with rituximab (comparator-GMALL chemotherapy) | Modified hyper-CVAD with rituximab (comparator-modified hyper-CVAD) | GRAALL-2005 regimen with rituximab (comparator-GRALL-2005 chemotherapy) | BFM-90 with rituximab and bortezomib (historical cohort treated with modified BFM-90 alone as comparator) |
| Total no. of rituximab infusions in induction | 1 | 2 | 2 | 5 |
| Total no. of rituximab infusions | 8 (induction and consolidation) | 12 (induction, intensification, and maintenance) | 16-18 All phases of treatment | 5 |
| Postinduction CR rate | 94% 81% in high-risk group (comparator arm- 91% in standard-risk and 88% in high-risk) | 92%-100% based on use of intensification (comparator arm, 94%) | 90% (89% in comparator arm) | 85.3% (70% in historical cohort) |
| Postinduction MRD level <10−4; evaluable patients/total) | 57% in standard-risk; Not reported (comparator arm- 27% in standard risk; Not reported); not reported for high-risk | 81% (at CR); 57/97 (compared with CD20– subset, 58%) | 65%; 49/105 (comparator arm- 61%; 36/104) | 70.9%; 31/34 (51.7%; 85/89 in historical cohort) |
| Day of bone marrow EOI MRD assessment | Day 24 | Day 21 | Day 29 | Day 29 |
| Post-consolidation MRD level <10−4 | 90% | NA | 91% | Postinduction plus consolidation, 87.5% |
| Consolidation time point | Week 16 | NA | Weeks 12-14 | Week 16 |
| MRD detection method | NA | Four-color MFC-sensitivity <1 × 10−4 | Multiplex real-time quantitative PCR Sensitivity at least 10−4 | 10-color MFC sensitivity 1 in 10−6 |
| Early death | 7% | NA | 7% | 3% |
| CR duration (%) | 5-year CRD, 80% | 3-year CRD, 67% | NA | 21-month CRD, 93.6% |
| 2-year EFS | NA | NA | 65% | Estimated 2-year EFS, 71.4% |
| OS (%) | 5 years, 71% | 3 years, 61% | 71% | Estimated 2-year OS, 71.4% |
| Grade 3/4 neuropathy | NA | NA | 4% (4/105) | 0 |
hyper-CVAD, hyper-fractionated cyclophosphamide, vincristine, doxorubicin, dexamethasone; MFC, multicolor flow cytometer; NA, data not available; PCR, polymerase chain reaction.