Phase II study of mini CHOP plus Rituximab in non previously treated patient aged over 80 years with CD20+ Diffuse Large B-cell Lymphoma - LNH03-7B

Phase 1

• Conditions: CD20+ diffuse large B-cell lymphoma

• Registration Number: EUCTR2007-001589-34-BE
• Lead Sponsor: GELA Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-25
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

- Patient with histologically proven CD20+ diffuse large B-cell lymphoma
- aged over 80 years
- Ann Arbor stage Ibulky, II, III or IV
- Age-adjusted International Prognostic Index equal to 1, 2 and 3
- Patient not previously treated
- ECOG performance status <= 2
- with a minimum life expectancy of 3 months
- Negative HIV, HBV and HCV serologies test <= 4 weeks
- Having previously signed a written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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
- Any history of treated or non-treated
- central nervous system or meningeal involvement by lymphoma
- contra-indication to any drug contained in the chemotherapy regimens
- any serious active disease
- Poor renal function, poor hepatic function 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 o cervical carcinoma
- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
- Adult patient under tutelage

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of R-miniCOP in patients aged over 80 years with not previously treated CD20+ diffuse large B-cell lymphoma as measured by the overall survival (OR);Secondary Objective: To evaluate the efficacy and the safety of R-miniCHOP as measured by EFS events, the response rate at the end of treatment, the progression rate, the DFS for complete responders and unconfirmed complete responders, the additional toxicities and evaluation of simplificated scale prognostic impact.;Primary end point(s): To evaluate the efficacy of R-miniCOP in patients aged over 80 years with not previously treated CD20+ diffuse large B-cell lymphoma as measured by the overall survival (OR)