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+

Phase 1

• Conditions: Patient with Diffuse Large B cells with IPI=0 not previously treated; MedDRA version: 12.1Level: LLTClassification code 10012818Term: Diffuse large B-cell lymphoma

• Registration Number: EUCTR2009-017279-77-FR
• Lead Sponsor: GELARC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-20
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

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) < 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified