Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-24 @ 12:44 PM
NCT ID:
NCT02128061
Eligibility Criteria:
Inclusion Criteria:
* Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) including all clinical subtypes (primary mediastinal, intravascular, etc…), with all age-adjusted International Prognostic Index (aaIPI).
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 lymph node; 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 (according to WHO classification); or CD20+ Aggressive B-cell lymphoma unclassifiable.
* With a Cluster of Differentiation antigen 10 (CD10) immunostaining performed by the participating center pathologist
* Aged ≥ 80 years old
* Ann Arbor stage II, III or IV
* Patient previously untreated for DLBCL Lymphoma
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* With a minimum life expectancy of 3 months
* Negative HIV, HBV and HCV serologies test within 4 weeks before inclusion (except after hepatitis B vaccination or for patients who are HBs Ag negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative)
* Patient able to give his consent and having signed a written Informed consent
* Patient affiliated to social security system, if applicable
* Male patients must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 3 months following study drug discontinuation, even if they have undergone a successful vasectomy.
* All patients must agree to fulfill the global Lenalidomide Pregnancy Prevention Risk Management Plan as applicable according to the randomization arm (randomization arm)
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 ; for anthracycline use, ejection fraction should be \> 50%
* Any serious active disease (according to the investigator's decision)
* History of deep venous thrombosis or arterial thromboembolism events within the past 12 months before inclusion
* Poor renal function (creatinine clearance \< 40 ml/min, according to Modification of Diet in Renal Disease (MDRD) formula)
* 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 (i.e., 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
* Prior use of lenalidomide
* Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide
* Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide
* Subjects with ≥ Grade 2 neuropathy
* Adult patient under tutelage
* Female of childbearing potential are excluded. (Note: Females are defined as not of childbearing potential if there is documentation of "natural menopause for at least 24 consecutive months, a hysterectomy or bilateral oophorectomy")
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
80 Years
Study:
NCT02128061
Study Brief:
Protocol Section:
NCT02128061