NCT00135499

R-ACVBP Versus R-CHOP in Patients Aged 60-65 With Diffuse Large B-cell Lymphoma

Randomized Study of ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Non Previously Treated Patients Aged From 60 to 65 Years With Diffuse Large B-Cell Lymphoma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Lymphoma Study Association · Academic / Other
• Sex: All
• Age: 60 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab in patients aged from 60 to 65 years with non-previously treated diffuse large B-cell lymphoma as measured by the event-free survival. The goal is to obtain a 10% increase of event-free survival at 3 years.

Detailed description

In Europe, 50% or more of new non-Hodgkin lymphoma cases occur in patients older than 60 years. More than 30% are diffuse large B-cell lymphomas (DLCL). The CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone) was considered as the standard treatment in this population. Nevertheless, this treatment is associated with some toxic events in elderly patients and it did does not succeed to increase the 3-year survival rate above 40%. Two trials in patients above 60 years with DLCL cases were conducted by the GELA in the aim to improve the results of CHOP. Protocol LNH 93-5 : The primary objective of this study was to compare CHOP to ACVBP in patients aged from 61 to 69 years with aggressive lymphoma and at least one adverse prognostic factor according to the International Prognostic Index. Unlike the CHOP regimen, the ACVBP regimen includes a more intensive induction followed by a sequential consolidation with drugs different from those used during the induction phase, and includes a prevention of neuromeningeal relapses. Out of 708 patients included in this study, the results have shown that: * Complete response rate was the same in the two arms. * Event free survival was significantly better in the ACVBP arm than the CHOP arm ( 5-year survival rate : 39% versus 29%, p=0.005). * Overall survival was significantly better in the ACVBP arm than in the CHOP arm (the 5-year survival rate : 46% versus 38%, p=0.036). * The ACVBP regimen was more toxic than the CHOP regimen, particularly in elderly patients (\> 65 years) and in patients with a low performance status. * Prevention of neuromeningeal relapses was necessary for these patients. Protocol LNH 98-5, the objective of this study was to compare the association CHOP + rituximab (R-CHOP) to the CHOP regimen alone in elderly patients with non previously treated diffuse large B-cell lymphoma. Long-term results based on data from 399 patients, with a median follow-up of 5 years were as follows : * Complete response rate was better in the R-CHOP arm than in the CHOP arm (76% versus 61%, p\<0.005). * Significant prolongation of event-free survival (p\<0.0002) and overall survival (p\<0.0073) in the R-CHOP arm. * No significant difference between the two arms in terms of toxicity. R-CHOP is now considered worldwide as the standard combination for these patients. These conclusions invited us to propose a randomized trial comparing ACVBP + rituximab to CHOP + rituximab. The study population is limited to patients aged from 60 to 65 years.

Conditions

• Lymphoma, Large-Cell, Diffuse

Interventions

Type	Name	Description
DRUG	Rituximab	375 mg/m², D1, 4 cycles
DRUG	Doxorubicin	75 mg/m², D1, 4 cycles
DRUG	Cyclophosphamide	1200 mg/m², D1, 4 cycles
DRUG	Vindesine	2 mg/m², D1, D5, 4 cycles
DRUG	Bleomycin	10 mg, D1, D5, 4 cycles
DRUG	Prednisone	60 mg, D1-D5, 4 cycles
DRUG	Prednisone	40 mg, D1-D5, 4 cycles
DRUG	Doxorubicin	50 mg/m², D1, 4 cycles
DRUG	Cyclophosphamide	750 mg/m², D1, 4 cycles
DRUG	Vincristine	1.4 mg/m², D1, 4 cycles

Timeline

• Start date: 2001-10-16
• Primary completion: 2010-04-27
• Completion: 2010-04-27
• First posted: 2005-08-26
• Last updated: 2018-08-23

Locations

8 sites across 3 countries: Belgium, France, Switzerland