Loading
AALL0232 showed that giving children with high-risk acute lymphoblastic leukaemia high doses of methotrexate with leucovorin rescue cured more of them than the older escalating schedule, and that the steroid dexamethasone helped children under ten but caused bone damage without benefit in older patients.
AALL0232 was the Children's Oncology Group phase 3 trial for high-risk B-cell acute lymphoblastic leukaemia, enrolling 3,154 patients aged 1 to 30 between 2004 and 2011, of whom 2,914 were randomised in a 2 by 2 design: dexamethasone for 14 days or prednisone for 28 days during induction, and high-dose methotrexate with leucovorin rescue or Capizzi escalating-dose methotrexate with pegaspargase during the first interim maintenance.
Interim monitoring showed the superiority of high-dose methotrexate and stopped enrolment in January 2011. Mature five-year event-free survival was 79.6 percent with high-dose methotrexate against 75.2 percent with Capizzi methotrexate, with fewer marrow and central nervous system relapses and no increase in acute toxicity. Children aged 1 to 9 given dexamethasone and high-dose methotrexate did best, while patients aged 10 and over gained nothing from dexamethasone and had more osteonecrosis. High-dose methotrexate became the standard for high-risk childhood disease, which is how the corpus's high-risk childhood leukaemia page cites the trial.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
3,154 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survival at 5 years, methotrexate randomisation (mature data)primary | High-dose methotrexate with leucovorin rescue | - | 79.6% | - | 0.008 | link |
| Capizzi escalating methotrexate with pegaspargase | - | 75.2% | ||||
| Event-free survival at 5 years, patients aged 1 to 9 by regimen | Dexamethasone + high-dose methotrexate | - | 91.2% | - | 0.015 | link |
| Dexamethasone + Capizzi methotrexate | - | 83.2% | ||||
| Prednisone + high-dose methotrexate | - | 80.8% | ||||
| Prednisone + Capizzi methotrexate | - | 82.1% | ||||
| Event-free survival at 5 years, patients aged 10 and over (registry results) | Dexamethasone + high-dose methotrexate | - | 77% | - | - | link |
| Dexamethasone + Capizzi methotrexate | - | 69.1% | ||||
| Prednisone + high-dose methotrexate | - | 75.8% | ||||
| Prednisone + Capizzi methotrexate | - | 73.5% |
Shares Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase), High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL), Children's Oncology Group (COG), Dexamethasone and the tag soc-trials.
Shares Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase), Methotrexate, Dexamethasone, Leukaemia (all types) and the tag soc-trials.
Shares Children's Oncology Group (COG), Leukaemia (all types), Acute lymphoblastic leukaemia, Cytotoxic chemotherapy and the tag soc-trials.
Shares Leukaemia (all types), Acute lymphoblastic leukaemia, Cytotoxic chemotherapy and the tag soc-trials.
Shares Leukaemia (all types), Acute lymphoblastic leukaemia, Cytotoxic chemotherapy and the tag soc-trials.
Shares Children's Oncology Group (COG), Leukaemia (all types), Acute lymphoblastic leukaemia and the tag soc-trials.
Shares Children's Oncology Group (COG), Prednisone, Cytotoxic chemotherapy and the tag soc-trials.
Shares Children's Oncology Group (COG), Leukaemia (all types), Cytotoxic chemotherapy and the tag soc-trials.