AALL0232
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.
Overview
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.
- 79.6 vs 75.2 out of 100 free of a major event at 5 years with High-dose methotrexate with leucovorin rescue compared with Capizzi escalating methotrexate with pegaspargase; 4.4 more per 100.
- Roughly one extra person helped for every 23 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.008) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- 91.2 vs 83.2 out of 100 free of a major event at 5 years with Dexamethasone + high-dose methotrexate compared with Dexamethasone + Capizzi methotrexate; 8 more per 100.
- Roughly one extra person helped for every 13 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Other groups: Prednisone + high-dose methotrexate 80.8 of 100; Prednisone + Capizzi methotrexate 82.1 of 100.
- The p-value (0.015) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- 77 vs 69.1 out of 100 free of a major event at 5 years with Dexamethasone + high-dose methotrexate compared with Dexamethasone + Capizzi methotrexate; 7.9 more per 100.
- Roughly one extra person helped for every 13 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Other groups: Prednisone + high-dose methotrexate 75.8 of 100; Prednisone + Capizzi methotrexate 73.5 of 100.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Newly diagnosed high-risk B-cell acute lymphoblastic leukaemia in patients aged 1 to 30: a 2 by 2 randomisation of dexamethasone or prednisone during induction and high-dose methotrexate or Capizzi escalating methotrexate with pegaspargase during interim maintenance. People in a different situation may not see the same effect.
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% |
Similar pages
not linked directly; found by shared links- TrialAALL1231
Shares Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase), Leukaemia (all types), High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL), Dexamethasone and the tag soc-trials.
- TrialALL R3 (UKALLR3)
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- TrialIntReALL SR 2010
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Shares Leukaemia (all types), Acute lymphoblastic leukaemia, Cytotoxic chemotherapy and the tag soc-trials.