PETHEMA ALL-HR-11 trial: chemotherapy schedule
Phase . | Route . | Dose . | Days . |
---|---|---|---|
Induction-1* | |||
Vincristine (maximum 2 mg) | IV | 1.5 mg/m2 | 1, 8, 15, 22 |
Daunorubicin | IV | 45 mg/m2 | 1, 8, 15, 22 |
Prednisone | IV | 60 mg/m2 | 1 to 14 |
IV | 30 mg/m2 | 15 to 21 | |
IV | 15 mg/m2 | 22 to 28 | |
Native ASP† or | IV | 10 000 IU/m2 | 16-20, 23-27 |
PEG-ASP†,‡ | IV | 2000 IU/m2 | 15 |
TIT§ | IT | 1, 22 | |
Induction-2‖ | |||
Idarubicin | IV | 12 mg/m2 | 1, 3, 5 |
Fludarabine | IV | 30 mg/m2 | 1-5 |
ARA-C | IV | 2000 mg/m2 | 1-5 |
TIT§ | IT | 7 | |
Early consolidation-1 | |||
Vincristine | IV | 2 mg | 1, 8 |
Dexamethasone | IV/PO | 20 mg/m2 | 1-5 |
IV/PO | 10 mg/m2 | 6 | |
IV/PO | 5 mg/m2 | 7 | |
IV/PO | 2.5 mg/m2 | 8 | |
Methotrexate¶ | IV | 3 or 5 g/m2 | 1 |
Native ASP† or | IV | 20 000 IU/m2 | 3 |
PEG-ASP†,‡ | IV | 2000 IU/m2 | 3 |
TIT§ | IT | 1 | |
Early consolidation-2 | |||
Dexamethasone | IV/PO | 20 mg/m2 | 1-5 |
IV/PO | 10 mg/m2 | 6 | |
IV/PO | 5 mg/m2 | 7 | |
IV/PO | 2.5 mg/m2 | 8 | |
ARA-C | IV | 2000 mg/m2/12h | 1, 2 |
Native ASP† or | IV | 20 000 IU/m2 | 3 |
PEG-ASP†,‡ | IV | 2000 IU/m2 | 3 |
TIT§ | IT | 4 | |
Early consolidation-3 | |||
Vincristine | IV | 2 mg | 1, 8 |
Dexamethasone | IV/PO | 20 mg/m2 | 1-5 |
IV/PO | 10 mg/m2 | 6 | |
IV/PO | 5 mg/m2 | 7 | |
IV/PO | 2.5 mg/m2 | 8 | |
Methotrexate¶ | IV | 3 or 5 g/m2 | 1 |
Native ASP† or | IV | 20 000 IU/m2 | 3 |
PEG-ASP†,‡ | IV | 2000 IU/m2 | 3 |
TIT§ | IT | 1 | |
Delayed consolidation-1# | |||
Vincristine | IV | 2 mg | 1, 8 |
Dexamethasone | IV/PO | 20 mg/m2 | 1-5 |
IV/PO | 10 mg/m2 | 6 | |
IV/PO | 5 mg/m2 | 7 | |
IV/PO | 2.5 mg/m2 | 8 | |
Methotrexate¶ | IV | 3 or 5 g/m2 | 1 |
Native ASP† or | IV | 20 000 IU/m2 | 3 |
PEG-ASP†,‡ | IV | 2000 IU/m2 | 3 |
TIT§ | IT | 1 | |
Delayed consolidation-2# | |||
Dexamethasone | IV/PO | 20 mg/m2 | 1-5 |
IV/PO | 10 mg/m2 | 6 | |
IV/PO | 5 mg/m2 | 7 | |
IV/PO | 2.5 mg/m2 | 8 | |
ARA-C | IV | 2000 mg/m2/12 h | 1, 2 |
Native ASP† or | IV | 20 000 IU/m2 | 3 |
PEG-ASP†,‡ | IV | 2000 IU/m2 | 3 |
TIT§ | IT | 4 | |
Delayed consolidation-3# | |||
Vincristine | IV | 2 mg | 1, 8 |
Dexamethasone | IV/PO | 20 mg/m2 | 1-5 |
IV/PO | 10 mg/m2 | 6 | |
IV/PO | 5 mg/m2 | 7 | |
IV/PO | 2.5 mg/m2 | 8 | |
Methotrexate¶ | IV | 3 or 5 g/m2 | 1 |
Native ASP† or | IV | 20 000 IU/m2 | 3 |
PEG-ASP†,‡ | IV | 2000 IU/m2 | 3 |
TIT§ | IT | 1 | |
Maintenance-1** | |||
Mercaptopurine | PO | 50 mg/m2 | Daily |
Methotrexate | IM | 20 mg/m2 | Weekly |
Reinductions†† | |||
Vincristine | IV | 2 mg | 1 |
Prednisone | PO | 60 mg | 1-7 |
TIT§ | IT | 1 | |
Maintenance-2‡‡ | |||
Mercaptopurine | PO | 50 mg/m2 | Daily |
Methotrexate | IM | 20 mg/m2 | Weekly |
Phase . | Route . | Dose . | Days . |
---|---|---|---|
Induction-1* | |||
Vincristine (maximum 2 mg) | IV | 1.5 mg/m2 | 1, 8, 15, 22 |
Daunorubicin | IV | 45 mg/m2 | 1, 8, 15, 22 |
Prednisone | IV | 60 mg/m2 | 1 to 14 |
IV | 30 mg/m2 | 15 to 21 | |
IV | 15 mg/m2 | 22 to 28 | |
Native ASP† or | IV | 10 000 IU/m2 | 16-20, 23-27 |
PEG-ASP†,‡ | IV | 2000 IU/m2 | 15 |
TIT§ | IT | 1, 22 | |
Induction-2‖ | |||
Idarubicin | IV | 12 mg/m2 | 1, 3, 5 |
Fludarabine | IV | 30 mg/m2 | 1-5 |
ARA-C | IV | 2000 mg/m2 | 1-5 |
TIT§ | IT | 7 | |
Early consolidation-1 | |||
Vincristine | IV | 2 mg | 1, 8 |
Dexamethasone | IV/PO | 20 mg/m2 | 1-5 |
IV/PO | 10 mg/m2 | 6 | |
IV/PO | 5 mg/m2 | 7 | |
IV/PO | 2.5 mg/m2 | 8 | |
Methotrexate¶ | IV | 3 or 5 g/m2 | 1 |
Native ASP† or | IV | 20 000 IU/m2 | 3 |
PEG-ASP†,‡ | IV | 2000 IU/m2 | 3 |
TIT§ | IT | 1 | |
Early consolidation-2 | |||
Dexamethasone | IV/PO | 20 mg/m2 | 1-5 |
IV/PO | 10 mg/m2 | 6 | |
IV/PO | 5 mg/m2 | 7 | |
IV/PO | 2.5 mg/m2 | 8 | |
ARA-C | IV | 2000 mg/m2/12h | 1, 2 |
Native ASP† or | IV | 20 000 IU/m2 | 3 |
PEG-ASP†,‡ | IV | 2000 IU/m2 | 3 |
TIT§ | IT | 4 | |
Early consolidation-3 | |||
Vincristine | IV | 2 mg | 1, 8 |
Dexamethasone | IV/PO | 20 mg/m2 | 1-5 |
IV/PO | 10 mg/m2 | 6 | |
IV/PO | 5 mg/m2 | 7 | |
IV/PO | 2.5 mg/m2 | 8 | |
Methotrexate¶ | IV | 3 or 5 g/m2 | 1 |
Native ASP† or | IV | 20 000 IU/m2 | 3 |
PEG-ASP†,‡ | IV | 2000 IU/m2 | 3 |
TIT§ | IT | 1 | |
Delayed consolidation-1# | |||
Vincristine | IV | 2 mg | 1, 8 |
Dexamethasone | IV/PO | 20 mg/m2 | 1-5 |
IV/PO | 10 mg/m2 | 6 | |
IV/PO | 5 mg/m2 | 7 | |
IV/PO | 2.5 mg/m2 | 8 | |
Methotrexate¶ | IV | 3 or 5 g/m2 | 1 |
Native ASP† or | IV | 20 000 IU/m2 | 3 |
PEG-ASP†,‡ | IV | 2000 IU/m2 | 3 |
TIT§ | IT | 1 | |
Delayed consolidation-2# | |||
Dexamethasone | IV/PO | 20 mg/m2 | 1-5 |
IV/PO | 10 mg/m2 | 6 | |
IV/PO | 5 mg/m2 | 7 | |
IV/PO | 2.5 mg/m2 | 8 | |
ARA-C | IV | 2000 mg/m2/12 h | 1, 2 |
Native ASP† or | IV | 20 000 IU/m2 | 3 |
PEG-ASP†,‡ | IV | 2000 IU/m2 | 3 |
TIT§ | IT | 4 | |
Delayed consolidation-3# | |||
Vincristine | IV | 2 mg | 1, 8 |
Dexamethasone | IV/PO | 20 mg/m2 | 1-5 |
IV/PO | 10 mg/m2 | 6 | |
IV/PO | 5 mg/m2 | 7 | |
IV/PO | 2.5 mg/m2 | 8 | |
Methotrexate¶ | IV | 3 or 5 g/m2 | 1 |
Native ASP† or | IV | 20 000 IU/m2 | 3 |
PEG-ASP†,‡ | IV | 2000 IU/m2 | 3 |
TIT§ | IT | 1 | |
Maintenance-1** | |||
Mercaptopurine | PO | 50 mg/m2 | Daily |
Methotrexate | IM | 20 mg/m2 | Weekly |
Reinductions†† | |||
Vincristine | IV | 2 mg | 1 |
Prednisone | PO | 60 mg | 1-7 |
TIT§ | IT | 1 | |
Maintenance-2‡‡ | |||
Mercaptopurine | PO | 50 mg/m2 | Daily |
Methotrexate | IM | 20 mg/m2 | Weekly |
ASP, asparaginase, IM, intramuscular administration; IT, intrathecal administration; PO, oral administration; TIT, triple intrathecal therapy.
Prephase with prednisone 60 mg/m2 and triple intrathecal therapy were given for a maximum of 1 wk, while ALL was fully characterized.
50% dose reduction in patients over 50 y old.
3750 IU (1 vial) in patients with body surface area over 1.8 m2.
Triple intrathecal therapy with methotrexate (15 mg), ARA-C (30 mg), and hydrocortisone (20 mg).
Only for patients who did not achieve CR after induction-1 or whose MRD level was ≥0.1%.
3 g/m2 for BCP-ALL, 5 g/m2 for T-ALL. Dose reduction to 1.5 g/m2 for patients aged >50 y.
Only for patients assigned to receive chemotherapy.
Until completing 1 y from the date of the complete remission.
Every month.
During the second year from the date of the complete remission.