Mini-CHOP and Rituximab in Patients Aged Over 80 Years

Launched by LYMPHOMA STUDY ASSOCIATION · Mar 15, 2010

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.