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.
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
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).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with Event-Free Survival at 2 years.
To evaluate the proportion of patients with event-free survival at 2 years in patients diagnosed of DLBCL with aIPI > 1 or aIPI=1 with elevated levels of beta 2-microglobulin (above UNL). UNL= Upper Normal Limit.
During treatment period, there will be assessments every 2 cycles. After end of treatment every 3 month the first year, every 6 months the second year and annually from 3rd to 5th year
Eva González, MD
Institut Catalá d'Oncología, Hospital Duran i Reynals
Spain: Spanish Agency of Medicines