| Methods |
Randomised controlled trial
Number of centres: 18
Location: Italy
Years: September 1994 ‐ September 1999
Target reached
Sponsorship: no industrial, Ministero dell' Univerita e Ricerca Scientifica (MURST) 40%, Italy
Central pathology review: yes
Definition of Complete Response: WHO criteria |
| Participants |
Number of patients randomised: 150 (150 analysed)
Our analysis: 150
Patients untreated: yes
INCLUDED:
Histology: aggressive non‐Hodgkin lymphoma (REAL‐classification) of diffuse large B‐cell, peripheral T‐cell, anaplastic lymphoma
IPI: age‐adjusted high‐intermediate and high‐risk
Age: 15‐60 years
EXCLUDED:
stage I non‐bulky; abnormal renal, pulmonary cardiac, and hepatic function; HIV, hepatitis B and C |
| Interventions |
Control group: MACOP‐B 12 weeks
Experimental group: MACOP‐B 8 weeks followed by high‐dose therapy and PBSC or ABMT
Involved field radiation allowed in both arms on bulky disease and residual mass
Randomization upfront |
| Outcomes |
Overall survival
Progression‐free survival
Relapse‐free survival
Response rates |
| Notes |
source: paper and personal communication |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
A ‐ Adequate |
