NCT01848132

Efficacy/Safety Study of R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI.

Multicenter Randomized Phase II Study of Treatment With R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Diffuse large B cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting for between 30% and 50% of the patients. Although it is considered a curable disease, still at least 40 % of the patients will fail first line chemotherapy. The International Prognostic Index (IPI) score and the age adjusted IPI (aIPI) has been used since they were published to identify patients with different outcome. There is not standard therapy for young patients with DLBCL and unfavourable IPI score. The survival of these patients remains poor, with EFS around 40%. The combination of RCHOP with new drugs is an attractive approach to treat these patients. The goal is to evaluate the proportion of patients with Event-Free Survival (EFS) after 2 years, with a diagnosis of DLBCL with an aIPI \> 1 or an aIPI =1 with increased levels of beta-2-microglobulin (above the Upper Limits of Normal.)

Detailed description

Diffuse large B cell lymphoma (DLBCL) is the most common non-Hodgkin's lymphoma, accounting for between 30% and 50% of the patients. Although it is considered a curable disease, still at least 40 % of the patients will fail first line chemotherapy. The International Prognostic Index (IPI) score and the age adjusted IPI (aIPI) has been used since they were published to identify patients with different outcome. CHOP chemotherapy administered every 21 days has been for years the standard therapy for advanced DLBCL achieving a long term overall survival (OS) of about 40%. Many studies show that the addition of the monoclonal antibody Rituximab improves the patients survival achieving higher rates of event-free survival in elderly patients with both,favourable and unfavourable IPI score. R-CHOP also improved survival in young patients with favourable IPI score. There is not standard therapy for young patients with DLBCL and unfavourable IPI score. The survival of these patients remains poor, with EFS around 40%. The combination of RCHOP with new drugs is an attractive approach to treat these patients. The investigators propose a phase II randomized clinical trial for young patients with unfavourable IPI score DLBCL using 6 cycles of the combination of subcutaneous Bortezomib with R-CAP (RCHOP without vincristine, to avoid neuropathy) comparing with the standard immunochemotherapy regimen R- CHOP every 21 days. The goal is to evaluate the proportion of patients with Event-Free Survival (EFS) after 2 years, with a diagnosis of DLBCL with aIPI \> 1 or aIPI =1 with increased levels of beta-2-microglobulin (above the Upper Limits of Normal).

Conditions

• Diffuse, Large B-Cell, Lymphoma

Interventions

Type	Name	Description
DRUG	Bortezomib	Bortezomib: subcutaneous, 1,3 mg/m2, day 1, 8, 15.
DRUG	Rituximab	Rituximab: intravenous, 375 mg/m2, day 1
DRUG	Cyclophosphamide	Cyclophosphamide: intravenous, 750 mg/m2, day 1
DRUG	Doxorubicin	Adriamycin:intravenous, 50 mg/m2, day 1
DRUG	Prednisone	Prednisone: oral, 100 mg, days 1-5
DRUG	Vincristine	Vincristine: intravenous, 1,4 mg/m2, day 1

Timeline

• Start date: 2013-10-03
• Primary completion: 2018-01-01
• Completion: 2018-08-01
• First posted: 2013-05-07
• Last updated: 2018-09-19

Locations

21 sites across 1 country: Spain