Overview
Mini-CHOP and Rituximab in Patients Aged Over 80 Years
Status:
Completed
Completed
Trial end date:
2010-06-01
2010-06-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Lymphoma Study AssociationTreatments:
Rituximab
Criteria
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.