PHASE II STUDY OF LOW DOSE CHEMOTHERAPY REGIMEN (MINI-CHOP) PLUS OFATUMUMAB (O) IN NON PREVIOULSY TREATED PATIENTS AGED OVER 80 YEARS WITH CD 20+ DIFFUSE LARGE B-CELL LYMPHOMA

Phase 1

• Conditions: Diffuse large B Cell lymphoma, Code EUDRA 10003899; MedDRA version: 13.1Level: PTClassification code 10003899Term: B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-017995-26-PT
• Lead Sponsor: GELARC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-30
• Last Update Posted: 19 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

?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: 0
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 120

Exclusion Criteria

?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