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. 2008 Jan 23;2008(1):CD004024. doi: 10.1002/14651858.CD004024.pub2

Vitolo.

Methods Randomised controlled trial 
 Number of centres: not clarified 
 Location: Italy 
 Years: January 1997 ‐ September 2000 
 Target reached 
 Sponsorship: Amgen, majority of funding industrial, main reports and database completed and held independently from sponsor 
 Number of withdrawals: 
 Central pathology review: no 
 Definition of complete response: WHO criteria
Participants Number of patients randomised: 130 (126 analysed) 
 Our analysis: 126 
 Patients untreated: yes 
 INCLUDED: 
 Histology: diffuse large cell, peripheral T‐cell, anaplastic large cell lymphoma (REAL classification) 
 IPI: age‐adjusted: intermediate‐high or high risk; OR patients with bone marrow involvement regardless of IPI score 
 Age: <60 years 
 EXCLUDED: 
 non‐advanced stage; abnormal renal, liver function; cardiac ejection <50%, inadequate bone marrow function (neutrophils < 1,5 x 1000000000/l, platelets < 50 x 1000000000/l); CNS involvement; performance status >2; neoplasia in the last 5 years; life expectancy < 3 months; HbsAg+, hepatitis C, HIV
Interventions Control group: MegaCEOP 6 to 8 cycles 
 Experimental group: APO 1 to 2 cycles followed by high‐dose therapy and ASCT 
 Patients in experimental arm with bone marrow involvement received 2 cycles APO, others 1 course 
 Randomization upfront
Outcomes Overall survival 
 Disease‐free survival 
 Failure‐free survival 
 Response rates
Notes source: abstract and personal communication 
 4 patients excluded from the analysis due to major violations
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk A ‐ Adequate

Patients untreated means: no lymphoma related treatment before study entry, according to inclusion and exclusion criteria: only stated criteria are mentioned (especially important for abstract as source, Randomisation upfront=before treatment