Patte 2007.
Methods | Multicentre, 4‐arm study. | |
Participants | Eligibility: non‐immune compromised; < 18 years or 21 years with newly diagnosed B‐cell lymphoma. Tumour staging: non‐resected stages I to III & stage IV, CNS negative (St Jude/ Murphy classification). 762 eligible; 657 randomised; results based on 637. |
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Interventions | A factorial design between 4 arms, 2 receiving half‐dose of C in the second induction course with C, O, P, AD (doxorubicon), MTX (1A versus 1B) and 2 not receiving the maintenance course M1 (2A versus. 2B). | |
Outcomes | Event‐free survival. Overall survival. Failure‐free survival. |
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Notes | All participants had a standard pre‐randomisation phase and received COP and COPADM1. Median follow up period 54 months. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Said to be done at national group level. |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding (performance bias and detection bias) All outcomes | High risk | Stated as an open trial. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 657 randomised but 20 excluded post randomisation due to wrong classification and lack of clinical data. |