Comparison of study ALL-BFM 90 and 95: differences in risk groups definitions and treatment
| . | ALL-BFM 90 . | ALL-BFM 95 . |
|---|---|---|
| All risk groups | ||
| Asparaginase preparation | Crasnitin | L-asparaginase Medac |
| Asparaginase dosage in protocol I | 10 000 IU/m2 per dose | 5000 IU/m2 per dose |
| SR* | ||
| SR criteria | No HR-90 criteria and BFM-RF <0.8 and no T-ALL and CNS-negative | No HR-95 criteria and age 1 to <6 years and WBC <20 × 109/L and no T-ALL |
| Chemotherapy protocol IA | 4 doses daunorubicin | 2 doses daunorubicin |
| Duration of maintenance for boys | 24 months from diagnosis | 36 months from diagnosis |
| MR* | ||
| MR criteria | No HR-90 criteria and BFM-RF >0.8 and/or T-ALL and/or CNS-positive | No HR-95 criteria and age <1 or >6 years and/or WBC >20 × 109/L and/or T-ALL |
| Presymptomatic cranial irradiation | 12 Gy | 0 Gy (T-ALL: 12 Gy) |
| Randomization protocol M | ± asparaginase | ± cytarabine |
| Randomization maintenance | − | Vincristine/dexamethasone pulses |
| HR* | ||
| HR criteria | PPR and/or no CR d33 and/or t(9;22) (or BCR/ABL) | PPR and/or no CR d33 and/or t(9;22) (or BCR/ABL) or t(4;11) (or MLL/AF4) |
| Consolidation/reinduction | 9 HR courses | 6 HR′ courses + protocol II |
| . | ALL-BFM 90 . | ALL-BFM 95 . |
|---|---|---|
| All risk groups | ||
| Asparaginase preparation | Crasnitin | L-asparaginase Medac |
| Asparaginase dosage in protocol I | 10 000 IU/m2 per dose | 5000 IU/m2 per dose |
| SR* | ||
| SR criteria | No HR-90 criteria and BFM-RF <0.8 and no T-ALL and CNS-negative | No HR-95 criteria and age 1 to <6 years and WBC <20 × 109/L and no T-ALL |
| Chemotherapy protocol IA | 4 doses daunorubicin | 2 doses daunorubicin |
| Duration of maintenance for boys | 24 months from diagnosis | 36 months from diagnosis |
| MR* | ||
| MR criteria | No HR-90 criteria and BFM-RF >0.8 and/or T-ALL and/or CNS-positive | No HR-95 criteria and age <1 or >6 years and/or WBC >20 × 109/L and/or T-ALL |
| Presymptomatic cranial irradiation | 12 Gy | 0 Gy (T-ALL: 12 Gy) |
| Randomization protocol M | ± asparaginase | ± cytarabine |
| Randomization maintenance | − | Vincristine/dexamethasone pulses |
| HR* | ||
| HR criteria | PPR and/or no CR d33 and/or t(9;22) (or BCR/ABL) | PPR and/or no CR d33 and/or t(9;22) (or BCR/ABL) or t(4;11) (or MLL/AF4) |
| Consolidation/reinduction | 9 HR courses | 6 HR′ courses + protocol II |
Risk groups as defined in ALL-BFM 90 and 95, respectively.