PHASE II STUDY OF MINI-CHOP PLUS OFATUMUMAB (O) IN NON PREVIOUSLY TREATED PATIENTS AGED OVER 80 YEARS WITH CD 20+ DIFFUSE LARGE B-CELL LYMPHOMA
Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO
classification 2008) including clinical subtypes (primitive mediastinal, intravascular,
etc.) May also be included : de Novo Transformed DLBCL from low grade lymphoma
(Follicular, other...) and DLBCL associated with some small cell infiltration in bone
- 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+ Aggressive B-cell lymphoma unclassifiable Aged over 80 years. Ann Arbor
stage I, II, III or IV. All aaIPI Patient non previously treated. All ECOG
performance status With a minimum life expectancy of 3 months. Negative HIV, HBV and
HCV serologies test < 4 weeks (except after vaccination). Patient able to give his
consent and having previously signed a written informed consent.
Patient affiliated to social security system, if applicable
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. 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
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. Patients previously diagnosed with
prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason
score <7, and a prostate specific antigen (PSA) <10 ng/mL prior to initial therapy, (2)
they had definitive curative therapy (ie, prostatectomy or radiotherapy) >2 years before
Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical
evidence of prostate cancer, and their PSA was undetectable if they underwent
prostatectomy or <1 ng/mL if they did not undergo prostatectomy.
Treatment with any investigational drug within 30 days before planned first cycle of
chemotherapy and during the study.
Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to
start of therapy Adult patient under tutelage.