Efficacy/Safety Study of R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI.
Status:
Completed
Trial end date:
2018-08-01
Target enrollment:
Participant gender:
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.)
Phase:
Phase 2
Details
Lead Sponsor:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea