Status:
UNKNOWN
Assessment of Survival and Autonomy With Rituximab Plus Chemotherapy or Rituximab Plus Lenalidomide for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Collaborating Sponsors:
cimiez hospital Nice
Institut Bergonié
Conditions:
Chemotherapy
Diffuse Large B-Cell Lymphoma (DLBCL), Nos
Eligibility:
All Genders
75+ years
Phase:
PHASE2
Brief Summary
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma. Annual incidence increases with age and achieves more than 30 per 100 000 patients 65 years old or over. Despite...
Eligibility Criteria
Inclusion
- Age ≥ 75 years old
- Histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2008) 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 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 or CD20+ Aggressive B-cell lymphoma unclassifiable
- Relapse ≥ 6 months
- ADL ≥ 2
- Negative HIV, HBV (anti-HBc negativity) and HCV serologies test within 4 weeks before inclusion
- Patient able to give his consent and having signed a written informed consent
- Registration in a national health-care system
Exclusion
- 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 maximum normal 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 carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for \<5 years
- Other serious and uncontrolled non-malignant disease.
- Insufficient proficiency of the French language and disability to complete a questionnaire
- Patient under guardianship
Key Trial Info
Start Date :
July 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04113226
Start Date
July 26 2021
End Date
December 1 2024
Last Update
February 8 2023
Active Locations (1)
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1
CHU Amiens
Amiens, France, 80054