Treatment schedule in the JALSG Ph+ALL213 study
| Drug . | Dose . | Schedule . |
|---|---|---|
| Prephase | ||
| PSL | 60 mg/m2 per d orally | D −7 to −1 |
| IND1 | ||
| Dasatinib | 140 mg once per d orally | D 1-28 |
| PSL | 60 mg/m2 per d orally | D 1-14 and taper |
| CNS prophylaxis | 15 mg of MTX + 4 mg of dexamethasone IT | D 22 |
| IND2 | ||
| CPM | 1200 (900*) mg/m2, dip, 3 h | D 1 |
| DNR | 45 (30*) mg/m2, dip, 1 h | D 1-3 |
| VCR | 1.3 mg/m2 (max 2 mg/body) IV | D 1, 8, 15, 22 |
| PSL | 60 (45*) mg/m2 per d orally | D 1-21 and taper |
| Dasatinib | 100 mg once per d orally | D 4-31 |
| CNS prophylaxis | 15 mg of MTX + 4 mg of dexamethasone IT | D 1 |
| C1 | ||
| MTX | 1000 mg/m2, dip, 24 h | D 1 |
| Cytarabine | 2000 (1000*) g/m2, dip, 3 h, every 12 h | D 2-3 |
| mPSL | 50 mg/body, every 12 h IV | D 1-3 |
| Dasatinib | 100 mg once per d orally | D 4-24 |
| CNS prophylaxis | 15 mg of MTX + 4 mg of dexamethasone IT | D 1 |
| C2 | ||
| CPM | 1200 mg/m2, dip, 3 h | D 1 |
| DNR | 45 mg/m2, dip, 1 h | D 1 |
| VCR | 1.3 mg/m2 (max 2 mg/body) IV | D 1 |
| PSL | 60 mg/m2 per d orally | D 1-7 and taper |
| Dasatinib | 100 mg once per d orally | D 2-22 |
| CNS prophylaxis | 15 mg of MTX + 4 mg of dexamethasone IT | D 1 |
| Maintenance33 | ||
| VCR | 1.3 mg/m2 (max 2 mg/body) IV | D 1 |
| PSL | 60 mg/m2 per d orally | D 1-7 and taper |
| dasatinib | 100 mg once per d orally | D 1-28 |
| Post-HSCT dasatinib | ||
| Dasatinib | 50, 70, or 100 mg per d orally | D 1-28 every 35 d × 10 cycles |
| Posttherapy for molecular relapse | ||
| Dasatinib | 100 max 180 mg once per d orally | Until physician decision |
| Drug . | Dose . | Schedule . |
|---|---|---|
| Prephase | ||
| PSL | 60 mg/m2 per d orally | D −7 to −1 |
| IND1 | ||
| Dasatinib | 140 mg once per d orally | D 1-28 |
| PSL | 60 mg/m2 per d orally | D 1-14 and taper |
| CNS prophylaxis | 15 mg of MTX + 4 mg of dexamethasone IT | D 22 |
| IND2 | ||
| CPM | 1200 (900*) mg/m2, dip, 3 h | D 1 |
| DNR | 45 (30*) mg/m2, dip, 1 h | D 1-3 |
| VCR | 1.3 mg/m2 (max 2 mg/body) IV | D 1, 8, 15, 22 |
| PSL | 60 (45*) mg/m2 per d orally | D 1-21 and taper |
| Dasatinib | 100 mg once per d orally | D 4-31 |
| CNS prophylaxis | 15 mg of MTX + 4 mg of dexamethasone IT | D 1 |
| C1 | ||
| MTX | 1000 mg/m2, dip, 24 h | D 1 |
| Cytarabine | 2000 (1000*) g/m2, dip, 3 h, every 12 h | D 2-3 |
| mPSL | 50 mg/body, every 12 h IV | D 1-3 |
| Dasatinib | 100 mg once per d orally | D 4-24 |
| CNS prophylaxis | 15 mg of MTX + 4 mg of dexamethasone IT | D 1 |
| C2 | ||
| CPM | 1200 mg/m2, dip, 3 h | D 1 |
| DNR | 45 mg/m2, dip, 1 h | D 1 |
| VCR | 1.3 mg/m2 (max 2 mg/body) IV | D 1 |
| PSL | 60 mg/m2 per d orally | D 1-7 and taper |
| Dasatinib | 100 mg once per d orally | D 2-22 |
| CNS prophylaxis | 15 mg of MTX + 4 mg of dexamethasone IT | D 1 |
| Maintenance33 | ||
| VCR | 1.3 mg/m2 (max 2 mg/body) IV | D 1 |
| PSL | 60 mg/m2 per d orally | D 1-7 and taper |
| dasatinib | 100 mg once per d orally | D 1-28 |
| Post-HSCT dasatinib | ||
| Dasatinib | 50, 70, or 100 mg per d orally | D 1-28 every 35 d × 10 cycles |
| Posttherapy for molecular relapse | ||
| Dasatinib | 100 max 180 mg once per d orally | Until physician decision |
Cyclophosphamide (CPM) was diluted in 500 mL of normal saline. Daunorubicin (DNR) was diluted in 100 mL of normal saline. High-dose MTX and cytarabine were diluted in 500 mL of 5% glucose solution. High-dose MTX was followed by a rescue with 15 mg of folinic acid (IV) every 6 h 8 times, starting 36 h after starting MTX perfusion. C1 and C2 were alternatively repeated for 4 cycles (C1-1, C2-1, C1-2, C2-2, C1-3, C2-3, C1-4, C2-4).
CNS, central nervous system; IT, intrathecally; JALSG, Japan Adult Leukemia Study Group; mPSL, methyl-prednisolone; PSL, prednisolone; VCR, vincristine.
Dose modification for patients age >59 years.