NCT00561379

Diffuse Large B Cell Lymphoma of the Adult: Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14-Rituximab

Frontline Therapy of Diffuse Large B Cell Lymphoma of the Adult ( 18 to 60 Years Old): Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14 -Rituximab. Multicentric Randomized Prospective Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of the protocol is to compare the outcome of patients with DLBCL stage II bulky, III or IV with 1 to 3 adverse prognostic factors according to the International prognostic index. Patients with eligibility criteria and who gave informed consent will be randomised between CHOP-14- Rituximab x 8 courses and High dose chemotherapy with rituximab including autologous stem cell support. The aim of the study is to compare the Event free survival between the two arms and to gain insight into the prognostic significance of several biological markers gathered at the time of diagnosis/randomisation ( i.e. Fcgamma R III A genotyping, DNA profile and BCL é expression).

Detailed description

Diffuse Large B Cell Lymphoma not previously treated

Conditions

• Lymphoma, Large-Cell, Diffuse

Interventions

Type	Name	Description
DRUG	CHOP+RITUXIMAB	CHOP-14- Rituximab x 8 courses
DRUG	CEEP-RITUXIMAB	High dose chemotherapy with rituximab including autologous stem cell support.

Timeline

• Start date: 2005-04-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2007-11-21
• Last updated: 2013-06-13

Locations

1 site across 1 country: France