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AALL0434 was the largest trial ever run in childhood T-cell leukaemia; it showed that adding the drug nelarabine to standard chemotherapy cut relapses, and that most children could be cured without radiation to the brain.
The Children's Oncology Group trial AALL0434 enrolled 1895 patients aged 1 to 30 with newly diagnosed T-cell acute lymphoblastic leukaemia or T-lymphoblastic lymphoma. Intermediate- and high-risk patients were randomised in a two-by-two design to augmented Berlin-Frankfurt-Munster chemotherapy with or without six courses of nelarabine, and to Capizzi escalating-dose methotrexate with pegaspargase or to high-dose methotrexate.
Nelarabine improved disease-free survival in T-cell leukaemia, with fewer central nervous system relapses, and the Capizzi methotrexate arm outperformed high-dose methotrexate. Cranial irradiation was omitted for all but the highest-risk group without excess central nervous system relapse. Overall survival across the trial was the best yet reported for T-cell leukaemia, and nelarabine became part of front-line therapy for higher-risk disease.
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.
1,895 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Disease-free survival at 5 years (nelarabine randomisation) | Nelarabine | 323 | 88.2% | - | 0.029 | link |
| No nelarabine | 336 | 82.1% | ||||
| Isolated or combined CNS relapse | Nelarabine | - | 1.3% | - | 0.0001 | link |
| No nelarabine | - | 6.9% | ||||
| Event-free survival at 5 years, all patients | All patients | 1,562 | 83.7% | - | - | link |
| Overall survival at 5 years, all patients | All patients | 1,562 | 89.5% | - | - | link |
Shares Children's Oncology Group (COG), Cytotoxic chemotherapy and the tag subtype-trials.
Shares Children's Oncology Group (COG), Cytotoxic chemotherapy and the tag subtype-trials.
Shares Cytotoxic chemotherapy and the tag subtype-trials.
Shares Methotrexate and the tag subtype-trials.
Shares Cytotoxic chemotherapy and the tag subtype-trials.
Shares Cytotoxic chemotherapy and the tag subtype-trials.
Shares Cytotoxic chemotherapy and the tag subtype-trials.
Shares Cytotoxic chemotherapy and the tag subtype-trials.