Treatment of Good Prognosis, BCL-6 Negative Diffuse Large Cell Lymphoma With CHOP-R in Patients < 61 Years Old.

Non-Hodgkin Lymphoma Clinical Trial

Official title: Selection of Young Patients (< 61 Years), With Good Prognosis Diffuse Large B Cell Lymphoma, According to the Immunophenotype (BCL-6 Negative) to be Treated With Chemoimmunotherapy, With R-CHOP. A Pilot Study.

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine whether a specific subtype of lymphoma responds optimally to treatment with rituximab and chemotherapy.

Clinical Trial Description

Treatment with rituximab and chemotherapy (R-CHOP)is the accepted treatment for young patients with diffuse large B cell Non-Hodgkin's Lymphoma. However not every patient benefits with this expensive therapy. Recent data suggest that patients with BCL-6 negative lymphoma are more sensitive to Rituximab therapy. It is also known that patients with high-intermediate and high IPI risk does not benefit form standard three weekly CHOP chemotherapy.

In this study we intend to define a subgroup of patients in whom this therapy will be of maximum benefit.

We will prospectively treat a group of patients with the following characteristics:

< 60 years old low and low intermediate IPI risk BCL-6 negative B-cell NHL Treatment regimen: R-CHOP (standard dosis) for 8 cycles ;

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

• NCT number: NCT00429065
• Study type: Observational
• Source: Instituto Nacional de Cancerologia de Mexico
• Contact: Silvia Rivas-Vera, MD
• Phone: 56 28 04 46
• Email: srivasv02@yahoo.com.mx
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2007
• Completion date: January 2007