Table 4.
miniHCVD-inotuzumab ozogamicin-blinatumomab regimen for acute lymphoblastic leukemia
| Treatment type | Schedule | Drug | Dose |
|---|---|---|---|
| Intensive phase | Cycles 1, 3 | Cyclophosphamide | 150 mg/m2 every 12 h, days 1–3 |
| Dexamethasone | 20 mg/d, days 1–4 and 11–14 | ||
| Vincristine | 2 mg flat dose, days 1 and 8 | ||
| Cycles 2, 4 | Methotrexate | 250 mg/m2, day 1 | |
| Cytarabine | 0.5 g/m2 every 12 hours, days 2 and 3 | ||
| Cycle 1 | Inotuzumab | 0.6 mg/m2, day 2 & 0.3 mg/m2, day 8 | |
| Cycles 2, 3, 4 | Inotuzumab | 0.3 mg/m2, days 2 and 8 | |
| Cycles 1, 2, 3, 4 | Rituximab* | 375 mg /m2 day 1 and 8 | |
| Consolidation phase | Cycle 5 | Blinatumomab | 9 μg/day, days 1–4; 28 μg/day days 5–28 |
| Cycles 6, 7, 8 | Blinatumomab | 28 μg/day days 1–28 | |
| Maintenance therapy | Months 1–3, 5–7, 9–11, 13–15 | Vincristine | 2 mg/d every month |
| Months 1–3, 5–7, 9–11, 13–15 | Prednisone | 50 mg/d for 5 days every month | |
| Months 4, 8, 12, 16 | Blinatumomab | 28 μg/day days 1–28 | |
| Months 1–3, 5–7, 9–11, 13–15 | 6-Mercaptopurine | 50 mg PO twice daily | |
| Months 1–3, 5–7, 9–11, 13–15 | Methotrexate | 10 mg/m2 PO weekly | |
| Central nervous system prophylaxis | Cycles 1, 3 | IT MTX-AraC | MTX 12 mg on day 2, AraC 100 mg day 8 |
| Cycles 2, 4 | IT AraC-MTX | AraC 100 mg on day 5, MTX 12 mg day 8 | |
| Supportive care | Cycles 1–4 | Pegfilgrastim | 6 mg subcutaneously day 4 |
| Cycles 1–5 | Ursodiol | 300 mg, 3 times daily |
Note: For Intensive phase, inotuzumab ozogamicin (INO) is administered in two split doses on day 2 and day 8. The first dose of INO is 0.6 mg/m2, each subsequent dose is 0.3 mg /m2. In the Consolidation phase, blinatumomab was initiated at 9 μg/day for 4 days and then escalated to 28 μg/day by continuous IV infusion for a total of 4 weeks followed by 2 weeks treatment-free interval, and the cycle is repeated every 6 weeks. *Rituximab was administered in patients with CD20 expression of 20% or higher. It was noted that the schedules of rituximab and CNS prophylaxis have been modified in the latest publications, and variations exist since the trials are still ongoing [116, 117]. For details on correct doses and schedules, those from original publications should be followed
Inotuzumab denotes inotuzumab ozogamicin; IT intrathecal, MTX methotrexate, AraC cytarabine