Mini-CHOP and Rituximab in Patients Aged Over 80 Years

Phase 2

Completed

• Conditions: Diffuse Large B-Cell Lymphoma
• Interventions: Drug: R mini CHOP

• Registration Number: NCT01087424
• Lead Sponsor: Lymphoma Study Association

Brief Summary

The purpose of the study is to evaluate efficacy and safety of R-miniCHOP for elderly patients with diffuse large B-Cell lymphoma (DLBC) Lymphoma aged over 80 years by measuring the overall survival.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2009-08-26
• Study First Submitted QC: 2010-03-15
• Study First Posted: 2010-03-16
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-22
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification). DLBCL with some small cell infiltration in bone marrow or lymph node may be included.
• Aged over 80 years.
• Ann Arbor stage I bulky, II, III or IV
• Age-adjusted International Prognostic Index equal to 0, 1, 2 and 3.
• Patient non previously treated.
• ECOG performance status ≤ 2.
• With a minimum life expectancy of 3 months.
• Negative HIV, HBV and HCV serologies test ≤ 4 weeks (except after vaccination).
• Having previously signed a written informed consent

Exclusion Criteria

• Any other histological type of lymphoma.
• Any history of treated or non-treated indolent lymphoma.
• Central nervous system or meningeal involvement by lymphoma.
• Contra-indication to any drug contained in the chemotherapy regimens.
• Any serious active disease (according to the investigator's decision).
• Poor renal function (creatinin level>150µmol/l), poor hepatic function (total bilirubin level>30mmol/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.
• 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
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
R mini CHOP	R mini CHOP	Induction : 3 cycles every 3 weeks Consolidation :3 cycles every 3 weeks

Primary Outcome Measures

Name	Time	Method
Evaluating efficacy of R-miniCHOP by overall survival	2 years overall survival

Secondary Outcome Measures

Name	Time	Method
Evaluating R-miniCHOP efficacy by Event free survival	2 years event free survival