Table 5.
Treatment Dosages Considered in the Model
| Treatment | Drug | Dosagea | |
|---|---|---|---|
| Intervention Treatment: Tisagenlecleucel | |||
| Lymphodepleting chemotherapyb | Regimen 1 | Fludarabine | 30 mg/m2 IV daily for 4 days |
| Cyclophosphamide | 500 mg/m2 IV daily for 2 days | ||
| Regimen 2 | Cytarabine | 500 mg/m2 IV daily for 2 days | |
| Etoposide | 150 mg/m2 IV daily for 3 days | ||
| CAR-T infusion | Tisagenlecleucel | For patients 50 kg and below: 0.2 to 5 x 106 CAR-positive viable T cells/kg body weight. For patients above 50 kg: 0.1 to 2.5 x 108 CAR-positive viable T cells (non-weight based). |
|
| Comparator Treatment: Salvage Chemotherapy | |||
| FLA-IDA | Fludarabine | 30 mg/m2 IV daily (5 doses) | |
| Cytarabine | 2,000 mg/m2 IV daily (5 doses) | ||
| Idarubicin | 8 mg/m2 IV daily (3 doses) | ||
Notes: aDosages validated by clinical experts. bBased on the ELIANA study, it was considered that 94.67% of patients received regimen 1; and 1.33% of patients, regimen 2.13,14
Abbreviations: CAR, chimeric antigen receptor; FLA-IDA, combination of fludarabine, cytarabine and idarubicin; IV, intravenous.