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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.
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.
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% |
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 Thioguanine, Children's Oncology Group (COG), Leukaemia (all types), Acute lymphoblastic leukaemia and the tag soc-trials.
Shares Asparaginase (pegaspargase, calaspargase pegol, Erwinia asparaginase), Dexamethasone, Leukaemia (all types), Acute lymphoblastic leukaemia 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 Bortezomib, Children's Oncology Group (COG), Leukaemia (all types), 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 Leukaemia (all types), Acute lymphoblastic leukaemia, Cytotoxic chemotherapy and the tag soc-trials.