Last updated: February 7, 2023
Sponsor: Centre Hospitalier Universitaire, Amiens
Overall Status: Active - Recruiting
Phase
2
Condition
Lymphoma, B-cell
Aging
Lymphoma
Treatment
N/AClinical Study ID
NCT04113226
PI2018_843_0051
Ages > 75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 75 years old
- Histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification
- including all clinical subtypes (primary mediastinal, intravascular, etc...),with all aaIPI. May also be included : transformed DLBCL from low grade lymphoma (Follicular, other...) and DLBCL associated with some small cell Infiltration in bonemarrow or lymph node or CD20+ B-cell lymphoma, with intermediate features betweenDLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkinlymphoma or CD20+ Follicular lymphoma grade 3B or CD20+ Aggressive B-cell lymphomaunclassifiable
- Relapse ≥ 6 months
- ADL ≥ 2
- Negative HIV, HBV (anti-HBc negativity) and HCV serologies test within 4 weeks beforeinclusion
- Patient able to give his consent and having signed a written informed consent
- Registration in a national health-care system
Exclusion
Exclusion Criteria:
- Central nervous system or meningeal involvement by lymphoma
- Poor renal function (creatinine clearance < 30 ml/min, according to MDRD formula)
- Poor hepatic function (total bilirubin level>30mmol/l, transaminases >2.5 maximumnormal level) unless these abnormalities are related to the lymphoma
- Neuropathy grade > 1
- Poor bone marrow reserve as defined by neutrophils<1.5 G/l or platelets<100 G/l,unless related to bone marrow infiltration
- Other concomitant or previous malignancy, except adequately treated in situ carcinomaof the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer incomplete remission for <5 years
- Other serious and uncontrolled non-malignant disease.
- Insufficient proficiency of the French language and disability to complete aquestionnaire
- Patient under guardianship
Study Design
Total Participants: 114
Study Start date:
July 26, 2021
Estimated Completion Date:
December 31, 2024
Connect with a study center
CHU Amiens
Amiens, 80054
FranceActive - Recruiting
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