New hope for elderly lymphoma patients: a gentler treatment that preserves independence
NCT ID NCT04113226
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial investigates whether combining rituximab with lenalidomide works as well as standard rituximab-based chemotherapy for patients aged 75 and older with relapsed diffuse large B-cell lymphoma. The study focuses not only on controlling the cancer but also on maintaining the patients' ability to perform daily activities independently. Participants receive either the lenalidomide combination or standard chemotherapy, with the goal of finding a treatment that balances effectiveness with quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rituximab and Lenalidomide
- What this could lead to
- If successful, this could offer a gentler, effective treatment option for elderly patients with relapsed DLBCL, helping them live longer while maintaining independence.
- What could go wrong
- This is a small, early-phase trial, so results may not apply broadly. Lenalidomide can cause side effects like low blood counts, fatigue, or blood clots.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
1 person
The number who actually took part.
- Started
-
Nov 2021
- Finished
-
Jun 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
75 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 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 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU Amiens
Amiens, 80054, France
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