Studies evaluating rituximab in ALL
| Trial | Study design | Patient population | Enrolled patients | Endpoints | Results | Reference |
| GRAAL | Randomized phase III | Adults with CD20+, Ph− B-ALL | 209 | EFS | 65% with rituximab (95% CI, 56% to 75%) versus 52% with standard of care (95% CI, 43% to 63%); HR=0.66; (95% CI, 0.45 to 0.98; p=0.04) | 15 |
| Thomas et al, JCO 2010 | Prospective, non-randomized | Adolescents and adults with de novo Ph− B-ALL | 282 | CR rate; 3-year CRD rate; OS rate | In the younger (age <60 years) CD20-positive subset, rates of CRD and OS were superior with the modified hyper-CVAD and rituximab regimens compared with standard hyper-CVAD (70% v 38%; p<.001% and 75% v 47%, p=.003).Older patients with CD20-positive ALL did not benefit from rituximab-based chemoimmunotherapy | 74 |
ALL, acute lymphoblastic leukemia; B-ALL, B-cell acute lymphoblastic leukemia; CR, complete response; CRD, CR duration; CVAD, fractionated cyclophosphamide, vincristine, doxorubicin, dexamethasone; EFS, event-free survival; OS, overall survival; Ph, Philadelphia chromosome.