Efficacy/Safety Study of R-CHOP vs Bortezomib-R-CAP for Young Patients With Diffuse Large B-cell Lymphoma With Poor IPI.
Condition: Diffuse, Large B-Cell, Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

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).
    

Intervention name(s): Bortezomib; Rituximab; Cyclophosphamide; Doxorubicin; Prednisone; Vincristine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Bortezomib: subcutaneous, 1,3 mg/m2, day 1, 8, 15.; Rituximab: intravenous, 375 mg/m2, day 1; Cyclophosphamide: intravenous, 750 mg/m2, day 1; Adriamycin:intravenous, 50 mg/m2, day 1; Prednisone: oral, 100 mg, days 1-5; Vincristine: intravenous, 1,4 mg/m2, day 1
Other intervention name(s): Velcade; Adriamycin
Intervention MeSH terms: Prednisone; Cyclophosphamide; Rituximab; Doxorubicin; Vincristine; Bortezomib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoma; Large B-Cell