Rummel 2010.
| Methods | Allocation generation: not reported Allocation concealment: not reported Blinding: no ITT: no Number of dropouts: 11/219 Median follow‐up: 33 months | |
| Participants | 219 randomised, 208 evaluable, adult patients
Type of lymphoma: follicular lymphoma, mantle cell lymphoma, lymphoplasmacytic lymphoma, other indolent lymphoma
Stage: 93% of patients allocated to bendamustine and 86% allocated to fludarabine stage III/IV Previous treatment: yes Mean age: 68 years (range 38 to 87 years) |
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| Interventions | Investigational intervention: Bendamustine 90 mg/m2 on days 1 to 2, and rituximab 375 mg/m2 on day 1; every 4 weeks, up to 6 cycles Comparator intervention: Fludarabine 25 mg/m2 on days 1 to 3 and rituximab 375 mg/m2 on day 1; every 4 weeks, up to 6 cycles |
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| Outcomes | Progression‐free survival Overall survival |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not reported |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "219 patients ... were randomized ...11 patients were not evaluable due to protocol violations, and were not followed further" Allocation of non‐evaluable patients is not reported |
| Selective reporting (reporting bias) | Low risk | Analyses were done as stated in protocol |
| Other bias | Unclear risk | Published as an abstract |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel were not blinded to allocated treatment |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
CHOP: cyclophosphamide, doxorubicin, vincristine, prednisone CLL: chronic lymphocytic leukaemia CR: complete response ITT: intention‐to‐treat iv: intravenous PR: partial response SLL: small lymphocytic lymphoma