CD20+ diffuse large B-cell lymphoma MedDRA version: 9.1 Level: LLT Classification code 10012818 Term: Diffuse large B-cell lymphoma
Conditions
Interventions
Product Name: PREDNISONE
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
CAS Number: 53032
Product Name: RITUXIMAB
Pharmaceutical Form: Solution for injection
Other descriptive name: RITU
Sponsors
Hospices Civils de Lyon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification). - Age from18 to 59 years, eligible for transplant. - Patient not previously treated. - Baseline FDG-PET Scan (PET0) performed before any treatment with at least one hypermetabolic lesion. - Index prognostic factors (IPI) 2 or 3. - With a minimum life expectancy of 3 months. - Negative HIV, HBV and HCV serologies £ 4 weeks (except after vaccination). - Having previously signed a written informed consent. - The subject must be covered by a social security system Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Any other histological type of lymphoma. - Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included. - 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 maximum normal level) unless these abnormalities are related to the lymphoma. - Poor bone marrow reserve as defined by neutrophils <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. - Any serious active disease (according to the investigator’s decision). - Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study. - Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception - Adult patient under tutelage. - Impossibility to performed a baseline PET scan (PET0) before randomization and treatment beginning
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the complete response rate according to PET criteria (Cf Chapter 8) after 4 cycles of R-ACVBP14 or R-CHOP14 in patients aged from 18 to 59 years with not previously treated diffuse large B-cell lymphoma with 2-3 adverse prognostic factors of the age-adjusted IPI.;Secondary Objective: - early response rate according to PET after 2 cycles - overall response rate after 4 cycles - toxicities of the two induction regimens - duration of response, progression-free and overall survival, in the two early (after 2 cycles) PET-negative and PET-positive groups according to the induction arms, and in the whole population -disease-free, progression-free, event-free and overall survival of patients submitted to autologous transplant and the toxicity of the BEAM regimen - biological factors, tumor biopsy influencing the patient treatment response and prognosis - Correlate the pharmacokinetic of rituximab to: patients characteristics at baseline, early response rate (2 cycles), overall and complete response rate (4 cycles) of induction treatment, duration of response, progression-free, overall survival in the two inductive arms, in the two early PET-negative and PET-positive groups according to the induction arms, and in the whole population;Primary end point(s): Complete Response Rate according to PET (CR) after the 4 induction cycle of either R-ACVBP14 or R-CHOP14. | — |
Countries
Belgium, France
Outcome results
None listed