Status and phase
Conditions
Treatments
About
This study is a multicentric randomized trial evaluating the efficacy of the combination R-ACVBP in patients 18 to 65 years with low risk localized diffuse large B-cell lymphoma.
Full description
Approximately 30 to 40% of diffuse large B cell lymphomas are localized at diagnosis (stage I-II). Until the seventies, radiotherapy was used as the single modality to treat these localized stages but no more than half of the patients were cured. From the eighties, anthracycline-based regimens combined or not with radiotherapy gave superior results in term of relapse free survival compared with radiotherapy alone. Later on Miller et al. published a randomized study showing that 3 cycles of CHOP combined with radiotherapy gave superior results in term of overall survival as compared with 8 cycles of CHOP. This study was recently updated with a follow up of more than 8 years and shows no more difference between the two arms, due to an excess of late mortality after the combined treatment.
Recently, two trials were conducted by the GELA to compare chemotherapy alone to a combined chemo-radiotherapy approach in patients with low risk localized diffuse large cell lymphoma (age-adjusted IPI = 0).
Considering these two trials, we concluded that radiotherapy given after chemotherapy did not give any benefit to elderly patients treated for a low risk localized diffuse large cell lymphoma, and that ACVBP regimen was superior to 3 CHOP + radiotherapy in patients <60 years, and has to be considered as the treatment of reference in these patients.
Two other GELA trials contributed recently to improve the treatment of diffuse large B cell lymphoma and have to be considered for the elaboration of future studies:
All the above-mentioned results led us to propose a randomized trial comparing ACVBP to ACVBP + rituximab (R-ACVBP) in previously untreated patients with low risk localized diffuse large B-cell lymphoma (age-adjusted IPI = 0), and to extend the upper age limit from 60 to 65 years.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
223 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal