Randomized phase II study of two associations of rituximab and chemotherapy, with a pet-driven strategy, in patients from 18 to 59 with DLBCL CD20+ lymphoma and 2 or 3 adverse prognostic factors of the age-adjusted IPI - LNH2007-3B
- Conditions
- CD20+ diffuse large B-cell lymphoma
- Registration Number
- EUCTR2007-000699-18-BE
- Lead Sponsor
- Groupe d'Etude des Lymphomes de l'Adulte(GELA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 222
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method