PHASE II STUDY OF MINI-CHOP PLUS OFATUMUMAB (O) IN NON PREVIOULSY TREATED PATIENTS AGED OVER 80 YEARS WITH CD 20+ DIFFUSE LARGE B-CELL LYMPHOMA
- Conditions
- Diffuse large B Cell lymphoma, Code EUDRA 10003899
- Registration Number
- EUCTR2009-017995-26-FR
- Lead Sponsor
- GELARC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
?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 marrow
-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+ Agressive 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.
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
?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 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. 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.
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 O-miniCHOP in patients aged over 80 years with not previously treated CD20+ diffuse large B-cell lymphoma as measured by the overall survival (OS). ;Secondary Objective: To evaluate the efficacy and the safety of O-miniCHOP as measured by the PFS (Progression Free Survival), EFS (Event Free Survival), response duration, the DFS (disease free survival) for complete responders and unconfirmed complete responders, response rate at the end of the treatment, the additional toxicities and evaluation of simplificated scale prognostic impact.;Primary end point(s): Overall survival will be measured to assess the benefit of ofatumumab associated to mini-CHOP from the date of inclusion to the date of death from any cause.
- Secondary Outcome Measures
Name Time Method