AALL1231
AALL1231 tried to improve treatment for T-cell leukaemia and lymphoma in children by adding bortezomib and by dropping routine radiotherapy to the brain; bortezomib clearly helped the lymphoma patients but not the whole group, and more than nine in ten children were spared cranial radiotherapy without more relapses.
Overview
AALL1231 was the Children's Oncology Group phase 3 trial for newly diagnosed T-cell acute lymphoblastic leukaemia and T-lymphoblastic lymphoma. 824 eligible patients enrolled between 2014 and 2017 were randomised to a modified augmented Berlin-Frankfurt-Munster regimen with or without bortezomib during induction and delayed intensification. The backbone used dexamethasone in place of prednisone and added two pegaspargase doses so that prophylactic cranial radiotherapy could be omitted in most patients (only 9.5 percent were scheduled to receive it, against 90.8 percent in the predecessor AALL0434).
Four-year event-free survival was 80.1 percent without bortezomib and 83.8 percent with it, not a significant difference, and overall survival followed the same pattern. Patients with T-lymphoblastic lymphoma did significantly better with bortezomib (four-year event-free survival 86.4 against 76.5 percent, overall survival 89.5 against 78.3 percent) with no excess toxicity. Comparison with AALL0434 patients who had cranial radiotherapy showed no difference in event-free or overall survival, so the trial is cited as the evidence that cranial irradiation can be limited to central nervous system involvement and the highest-risk patients.
- 83.8 vs 80.1 out of 100 free of a major event at 4 years with Modified augmented BFM + bortezomib compared with Modified augmented BFM; 3.7 more per 100.
- Roughly one extra person helped for every 27 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.131) means the difference could plausibly be due to chance.
- 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.
- 88.3 vs 85.7 out of 100 alive at 4 years with Modified augmented BFM + bortezomib compared with Modified augmented BFM; 2.6 more per 100.
- Roughly one extra person helped for every 38 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.085) means the difference could plausibly be due to chance.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 86.4 vs 76.5 out of 100 free of a major event at 4 years with Modified augmented BFM + bortezomib compared with Modified augmented BFM; 9.9 more per 100.
- Roughly one extra person helped for every 10 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.041) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- 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.
- 89.5 vs 78.3 out of 100 alive at 4 years with Modified augmented BFM + bortezomib compared with Modified augmented BFM; 11.2 more per 100.
- Roughly one extra person helped for every 9 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.009) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 85.1 vs 81.7 out of 100 free of a major event at 3 years with Modified augmented BFM + bortezomib compared with Modified augmented BFM; 3.4 more per 100.
- Roughly one extra person helped for every 29 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- Put another way, the treated group had about 22 percent lower chance of the event at any given time (hazard ratio 0.782, likely range 0.561 to 1.091).
- The likely range for the hazard ratio crosses 1, so the difference could be due to chance.
- 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 T-cell acute lymphoblastic leukaemia and stage II to IV T-lymphoblastic lymphoma in children and young adults: a modified augmented BFM regimen with or without bortezomib during induction and delayed intensification, with prophylactic cranial radiotherapy removed for most patients. 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.
847 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survival at 4 years, all randomised patientsprimary | Modified augmented BFM + bortezomib | - | 83.8% | - | 0.131 | link |
| Modified augmented BFM | - | 80.1% | ||||
| Overall survival at 4 years, all randomised patients | Modified augmented BFM + bortezomib | - | 88.3% | - | 0.085 | link |
| Modified augmented BFM | - | 85.7% | ||||
| Event-free survival at 4 years, T-lymphoblastic lymphoma | Modified augmented BFM + bortezomib | - | 86.4% | - | 0.041 | link |
| Modified augmented BFM | - | 76.5% | ||||
| Overall survival at 4 years, T-lymphoblastic lymphoma | Modified augmented BFM + bortezomib | - | 89.5% | - | 0.009 | link |
| Modified augmented BFM | - | 78.3% | ||||
| Event-free survival at 3 years, all randomised patients (registry results) | Modified augmented BFM + bortezomib | - | 85.1% | 0.782 (0.561 to 1.091) | 0.074 | link |
| Modified augmented BFM | - | 81.7% |
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