| Methods |
Randomised controlled trial
Number of centres: 22
Location: Netherlands, Belgium, Spain, Italy
Years: December 1990 ‐ October 1998
Final analysis
Sponsorship: Public Health Service from the National Cancer Institute, National Institutes of Health, Department of Health and Human Servivces
Central pathology review: yes
Definition of complete response: WHO criteria |
| Participants |
Number of patients randomised: 194 (194 patients analysed)
Our analysis: 194
Patients untreated: yes
INCLUDED:
Histology: groups D, E, F, and G (Working Formulation), additionally stages I bulky, II, III, and IV with diffuse large‐cell immunoblastic, anaplastic large‐cell, large and small cell pleomorphic T‐cell, and angio‐immunblastic with dysproteinaemia‐like T‐cell lymphoma
IPI: no restriction
Age: 15‐60 years
EXCLUDED:
low‐grade, lymphoblastic and Burkitt lymphoma, stage I, performance status (WHO) greater than 2, severe cardiac, pulmonary, neurologic, or metabolic disease |
| Interventions |
Control group: CHVmP/BV 8 cycles
Experimental group: CHVmP/BV 6 cycles followed by BEAC and ABMT or PSCT
Radiotherapy allowed in both arms
Randomization: after 3 cycles CHVmP/BV for patients in CR or PR without involvement of bone marrow and without contradictions for bone marrow ablative therapy (WHO performance status 0 or 1, no severe cardiac, pulmonary, neurologic, infectious, or metabolic disease) |
| Outcomes |
Progression‐free survival
Overall survival |
| Notes |
source: paper and personal communication |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
