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GRAALL-2005 treated adults with acute lymphoblastic leukaemia using an intensive protocol borrowed from children's medicine and asked whether giving cyclophosphamide in a more intense split schedule helped; it did not, and the trial also showed that people aged 55 and over tolerate the paediatric-style treatment poorly.
GRAALL-2005 was the French, Belgian and Swiss GRAALL group's randomised phase 3 protocol for adults aged 18 to 59 with newly diagnosed acute lymphoblastic leukaemia. Patients were assigned by immunophenotype and genetics to three linked trials (T-cell or Philadelphia-negative B-cell disease, CD20-positive B-cell disease with or without rituximab, and Philadelphia-positive disease under GRAAPH-2005). The paediatric-inspired backbone came from the earlier GRAALL-2003 study. The randomised question reported in 2018 was whether hyperfractionated cyclophosphamide in first induction and late intensification improved outcomes.
Among 787 evaluable patients the complete remission rate was 91.9 percent, five-year event-free survival 52.2 percent and overall survival 58.5 percent. Hyperfractionated cyclophosphamide did not raise the remission rate or lengthen event-free or overall survival, except in the minority aged 55 and over, who otherwise tolerated the whole programme poorly. The protocol is one of the reference paediatric-inspired regimens for younger adults, alongside CALGB 10403 and UKALL.
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.
1,080 enrolled.
95% CI 48.5 to 55.7; hyperfractionated cyclophosphamide did not change the rate
Source95% CI 54.8 to 61.9
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete remission | All evaluable patients on the paediatric-inspired protocol | 787 | 91.9% | - | - | link |
| Event-free survival at 5 yearsprimary | All evaluable patients on the paediatric-inspired protocol | 787 | 52.2% | - | - | link |
| Overall survival at 5 years | All evaluable patients on the paediatric-inspired protocol | 787 | 58.5% | - | - | link |
| Event-free survival at 5 years by age | Age under 55 | - | 55.7% | 2.16 | <0.001 | link |
| Age 55 and over | - | 25.8% |
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.
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.
Shares Cyclophosphamide, Cytotoxic chemotherapy and the tag soc-trials.
Shares Cyclophosphamide, Cytotoxic chemotherapy and the tag soc-trials.