Patient with Diffuse Large B cells with IPI=0 not previously treated MedDRA version: 12.1 Level: LLT Classification code 10012818 Term: Diffuse large B-cell lymphoma
Conditions
Interventions
Product Name: rituximab
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Product Name: Prednisone
Pharmaceutical Form: Tablet
INN or P
Sponsors
GELARC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other...) may also be included. Or CD20+ B-cell lymphoma with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma Or CD20+ Follicular lymphoma grade 3B, Or CD20+ Agressive B-cell lymphoma unclassifiable - Age from18 to 80 years. - Patient not previously treated. - Ann Arbor Stage : I or II - Normal level of LDH. - ECOG performance status (PS) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Any other histological type of lymphoma, Burkitt included. - Any history of treated or non-treated small B-cell lymphoma - Central nervous system or meningeal involvement by lymphoma. - Contra-indication to any drug contained in the chemotherapy regimens. - Poor renal function (creatinin level >150 mmol/L), poor hepatic function (total bilirubin level >30 mmol/L, transaminases >2.5 ULN) unless these abnormalities are related to the lymphoma. - Poor bone marrow reserve as defined by Absolute Neutrophils Count (ANC) <1.5 G/L or platelets <100 G/L, unless related to bone marrow infiltration. - Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. -Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception - Adult patient under tutelage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate by PFS at 3 years the non-inferiority of a chemotherapy treatment with 4 or 6 cycles of R-CHOP 21, determined according to early response assessed by PET at the end of 2 cycles versus standard chemotherapy of 6 cycles of R-CHOP 21 in patients with DLBCL lymphoma CD20+ with no factors of the IPI age adjusted. ;Secondary Objective: - Determine the rate of good responders according to the result at PET after 2 cycles R-CHOP21. - Evaluate the overall response rate according to IWC (International Harmonization Project – Cheson 2007) (CR, PR) after 4 or 6 cycles of R-CHOP21 according to the treatment arm. - Determine the decrease of SUV max between PET at baseline, PET after cycle 2 and PET after cycle 4 and evaluate the changes predictive interest. - Assess the duration of response and overall survival. - Evaluate the prognostic impact of the existence of a high tumor burden at diagnosis (> 10 cm). - Identify the biological factors on blood samples and on tumor biopsy influencing the patient treatment response and prognosis. ;Primary end point(s): The primary objective of the trial is to find out whether the investigational treatment is non inferior to the standard therapy. The primary endpoint is progression-free survival (PFS). PFS will be measured from the date of randomization to the date of first documented disease progression, relapse or death from any cause, whichever occurs first. Patients alive and free of progression will be censored at their last follow-up date. | — |
Countries
Belgium, France
Outcome results
None listed