Study regimen
| Phase . | Treatment details . |
|---|---|
| Venetoclax ramp-up | DL1 (400 mg daily) |
| Ramp-up: day 1, 20 mg; day 2, 50 mg; day 3, 100 mg; day 4, 200 mg; days 5 and 6, 400 mg | |
| DL2 (600 mg daily) | |
| Ramp-up: day 1, 50 mg; day 2, 100 mg; day 3, 200 mg; day 4, 400 mg; days 5 and 6, 600 mg | |
| Venetoclax plus mini-HCVD | Venetoclax (by mouth) daily, days 1-21, per DL (DL1, 400 mg; DL2, 600 mg) |
| A cycles (1, 3, 5, and 7) | |
| Cyclophosphamide (IV) 150 mg/m2 twice daily, days 1-3 | |
| Vincristine (IV) 2 mg, days 1 and 8 | |
| Dexamethasone (IV or by mouth) 20 mg daily, days 1-4, 8-11 | |
| Rituximab (IV) 375 mg/m2, days 2 and 8, cycles 1 and 3 (if CD20+ of ≥1%) | |
| IT cytarabine/IT methotrexate | |
| B cycles (2, 4, 6, and 8) | |
| Methotrexate (IV) 250 mg/m2, day 1 | |
| Cytarabine (IV) 500 mg/m2 twice daily, days 2 and 3 | |
| Methylprednisolone (IV) 50 mg twice daily, days 1-3 | |
| IT cyatarabine/IT methotrexate | |
| Rituximab (IV) 375 mg/m2, days 2 and 8, cycles 2 and 4 (in CD20+ of ≥1%) | |
| Venetoclax plus POMP | Venetoclax (by mouth) daily 400 mg, days 1-28 |
| 6 mercaptopurine 50 mg (by mouth) twice daily, days 1-28 | |
| Vincristine 2 mg (IV), day 1 | |
| Methotrexate 10 mg/m2 (by mouth), days 1, 8, 15, and 22 | |
| Prednisone 50 mg (by mouth) daily, days 1-5 |
| Phase . | Treatment details . |
|---|---|
| Venetoclax ramp-up | DL1 (400 mg daily) |
| Ramp-up: day 1, 20 mg; day 2, 50 mg; day 3, 100 mg; day 4, 200 mg; days 5 and 6, 400 mg | |
| DL2 (600 mg daily) | |
| Ramp-up: day 1, 50 mg; day 2, 100 mg; day 3, 200 mg; day 4, 400 mg; days 5 and 6, 600 mg | |
| Venetoclax plus mini-HCVD | Venetoclax (by mouth) daily, days 1-21, per DL (DL1, 400 mg; DL2, 600 mg) |
| A cycles (1, 3, 5, and 7) | |
| Cyclophosphamide (IV) 150 mg/m2 twice daily, days 1-3 | |
| Vincristine (IV) 2 mg, days 1 and 8 | |
| Dexamethasone (IV or by mouth) 20 mg daily, days 1-4, 8-11 | |
| Rituximab (IV) 375 mg/m2, days 2 and 8, cycles 1 and 3 (if CD20+ of ≥1%) | |
| IT cytarabine/IT methotrexate | |
| B cycles (2, 4, 6, and 8) | |
| Methotrexate (IV) 250 mg/m2, day 1 | |
| Cytarabine (IV) 500 mg/m2 twice daily, days 2 and 3 | |
| Methylprednisolone (IV) 50 mg twice daily, days 1-3 | |
| IT cyatarabine/IT methotrexate | |
| Rituximab (IV) 375 mg/m2, days 2 and 8, cycles 2 and 4 (in CD20+ of ≥1%) | |
| Venetoclax plus POMP | Venetoclax (by mouth) daily 400 mg, days 1-28 |
| 6 mercaptopurine 50 mg (by mouth) twice daily, days 1-28 | |
| Vincristine 2 mg (IV), day 1 | |
| Methotrexate 10 mg/m2 (by mouth), days 1, 8, 15, and 22 | |
| Prednisone 50 mg (by mouth) daily, days 1-5 |
IT, intrathecal.