Randomized Phase III study evaluating the non-inferiority of a treatment adapted to the early response evaluated with 18F-FDG PET compared to a standard treatment, for patients aged from 18 to 80 years with low risk (aa IPI = 0) diffuse large B-cells non hodgkin's lymphoma CD 20+
- Conditions
- Patient with Diffuse Large B cells with IPI=0 not previously treatedMedDRA version: 18.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-017279-77-BE
- Lead Sponsor
- YSARC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 650
-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) < 2.
- Age-adjusted international prognostic index (aaIPI) = 0
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 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 390
- 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 nonmelanoma
skin tumors or stage 0 (in situ) cervical carcinoma.
- Positive HIV, HBV and HCV serologies before inclusion (except after
hepatitis B vaccination or for patients who are HBs Ag negative, anti-
HBs positive and/or anti-HBc positive but viral DNA negative).
-Pregnant or lactating women or women of childbearing potential not
currently practicing an adequate method of contraception
- Adult patient under tutelage.
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