NCT04113226CompletedPhase 2
Assessment of Survival and Autonomy With Rituximab Plus Chemotherapy or Rituximab Plus Lenalidomide for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma
Source: ClinicalTrials.gov · Last updated 12 Jun 2026
Brief summary (registry, in English)
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 high response rates with conventional regimen as R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone), 30% to 40% of patients develop a relapse or a refractory disease, with a poor prognosis. There is no standard chemotherapy in second line for elderly patients, which are not eligible to receive a salvage treatment by high-dose therapy followed by autologous stem cell transplantation. The median progression-free-survival (PFS) is less than one year with the most commonly used regimens including R-Gemcitabine-Oxaliplatin (R-GEMOX) and R-Bendamustine. One the other side, Rituximab plus Lenalidomide, an immunomodulatory agent, is an active new therapeutic approach, with an efficacy proved in a phase II trial with a patients with a prolonged disease-free-survival of 32 months for responders in patients with a median age of 74 years old. This combination is also efficient in the ABC phenotype DLBCL which is more common in elderly patients. For elderly patients, a management of the geriatric impairment together with lymphoma is required. Indeed, a comprehensive geriatric assessment detects frailty and vulnerability in elderly with a lymphoma and predicts severe treatment related toxicity, treatment settings and progression free survival. Moreover, geriatric intervention improved outcome, autonomy and quality of life. Functional status, assessed by Activities of patients Daily Living (ADL) is an independent predictive factor for feasibility of chemotherapy in elderly patients with cancer. The mini Data Set of DIALOG group is a new simplified geriatric assessment for oncologist.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- First submitted
- 1 Oct 2019
- Start date
- 9 Nov 2021
- Primary completion date
- 4 Jun 2024
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT04113226
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 1
- From 9 Nov 2021 to the primary completion date, 4 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other serious and uncontrolled non-malignant disease.
Lab values
- 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
- Poor bone marrow reserve as defined by neutrophils\<1.5 G/l or platelets\<100 G/l, unless related to bone marrow infiltration
Age
- 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
- Central nervous system or meningeal involvement by lymphoma
- Neuropathy grade \> 1
- Insufficient proficiency of the French language and disability to complete a questionnaire
- Patient under guardianship
Who the study is looking for
- 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
Age in the registry: 75 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Coordinator of this site? Confirm its status | Amiens | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.