ChemotherapyPhase 2RelyageNCT04113226
Assessment of Survival and Autonomy With Rituximab Plus Chemotherapy or Rituximab Plus Lenalidomide for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma
A Phase 2 study testing Rituximab, Lenalidomide 20 MG and Comprehensive Geriatric Assessment (CGA) in people with Chemotherapy and Diffuse Large B-Cell Lymphoma (DLBCL), Nos, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Chemotherapy, Diffuse Large B-Cell Lymphoma (DLBCL), Nos, Elderly
- What is being tested?
- Rituximab, Lenalidomide 20 MG and Comprehensive Geriatric Assessment (CGA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2021to 4 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Other serious and uncontrolled non-malignant disease.
- Insufficient proficiency of the French language and disability to complete a questionnaire
- Patient under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Rituximab, Lenalidomide 20 MG, Comprehensive Geriatric Assessment (CGA), Activities of daily living (ADL) scale
- Keywords
- chemotherapy, Diffuse large B cell lymphoma (DLBCL), Relapse, activities of patients daily living, Elderly, Lenalidomide
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating, Lymphoma, Large B-Cell, Diffuse, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
patients ≥ 75 years old with relapsed Diffuse large B-cell lymphoma will be treated with classical Rituximab-based chemotherapy or Rituximab plus Lenalidomide.
Lenalidomide 20 MGDrug
patients ≥ 75 years old with relapsed Diffuse large B-cell lymphoma will be treated with Rituximab plus Lenalidomide. Four 28-days cycles of oral Lenalidomide (20 mg / d for 21 days) and Rituximab 375mg/m2 on day 1 and day 21. After this induction phase, patients achieving at least stable disease were given lenalidomide maintenance therapy (20 mg for 21 days) until progression
Comprehensive Geriatric Assessment (CGA)Other
A comprehensive geriatric assessment (CGA) is recommended by the Société Internationale d'Onco Gériatrie (SIOG) in order to assess all geriatric facets (comorbidity, functional impairment, nutritional status, mental and psychological status, environment,…) on which treatment may impact.
Activities of daily living (ADL) scaleOther
Activities of daily living (ADL) comprise the basic actions that involve caring for one's self and body, including personal care, mobility, and eating. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
| Study group | Role | What they receive |
|---|---|---|
| classical rituximab-based chemotherapy | Active comparator | Rituximab-based physician's choice chemotherapy Receives: Drug: Rituximab; Other: Comprehensive Geriatric Assessment (CGA); Other: Activities of daily living (ADL) scale |
| rituximab plus lenalidomide | Experimental | Four 28-days cycles of oral Lenalidomide (20 mg / d for 21 days) and Rituximab 375mg/m2 on day 1 and day 21. After this induction phase, patients achieving at least stable disease were given lenalidomide maintenance therapy (20 mg for 21 days) until progression. Receives: Drug: Rituximab; Drug: Lenalidomide 20 MG; Other: Comprehensive Geriatric Assessment (CGA); Other: Activities of daily living (ADL) scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of free survival at 6 months in elderly patients treated with Rituximab plus Lenalidomide or Rituximab plus chemotherapy.
Progression of free survival at 6 months with maintain autonomy without loss of 0.5 point of ADL in elderly patients 75 years old and over with relapsed diffuse large B-cell lymphoma treated with Rituximab plus Lenalidomide or Rituximab plus investigator's choice .
Measured: at 6 months
Secondary outcomes (2)
Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups
Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups
Measured: at 6 months
Overall survival rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups
Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start9 Nov 2021
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChemotherapyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- cimiez hospital Nice, Institut Bergonié, groupe hospitalier public sud de l'oise, Henri Mondor University Hospital, Centre Henri Becquerel, Hôpital Charles Foix, Saint-Louis Hospital, Paris, France
- Responsible party
- Sponsor
- Investigators
- Frederic Peyrade, MD, Principal investigator, Centre Antoine Lacassagne, NiceBoulhassass, MD, Principal investigator, Hopital Cimiez NICESoubeyran, Pr, Principal investigator, Institut Bergonié BordeauxPhilippe Caillet, MD, Principal investigator, Hôpital Henri Mondor, APHP CRETEILFabrice Jardin, MD, Principal investigator, Centre Henri Becquerel, ROUENPascal Chaibi, MD, Principal investigator, Hôpital Charles Foix, APHP IVRY/SEINECatherine Thieblemont, MD, Principal investigator, Hôpital Saint-louis, APHP, PARISDamaj, MD, Principal investigator, Centre Hospitalier Universitaire de Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113226
- Sponsor's protocol ID
- PI2018_843_0051
- Acronym
- Relyage
- Status last verified
- Jun 2026
- First submitted
- 1 Oct 2019
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Survival and Autonomy With Rituximab Plus Chemotherapy or Rituximab Plus Lenalidomide for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04113226
- Acronym / sponsor ID
- Relyage / PI2018_843_0051
- Keywords
- chemotherapy, Diffuse large B cell lymphoma (DLBCL), Relapse, activities of patients daily living, Elderly, Lenalidomide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- cimiez hospital Nice, Institut Bergonié, groupe hospitalier public sud de l'oise, Henri Mondor University Hospital, Centre Henri Becquerel, Hôpital Charles Foix, Saint-Louis Hospital, Paris, France
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classical rituximab-based chemotherapy | Active comparator | Drug: Rituximab, Other: Comprehensive Geriatric Assessment (CGA), Other: Activities of daily living (ADL) scaleRituximab-based physician's choice chemotherapy |
| rituximab plus lenalidomide | Experimental | Drug: Rituximab, Drug: Lenalidomide 20 MG, Other: Comprehensive Geriatric Assessment (CGA), Other: Activities of daily living (ADL) scaleFour 28-days cycles of oral Lenalidomide (20 mg / d for 21 days) and Rituximab 375mg/m2 on day 1 and day 21. After this induction phase, patients achieving at least stable disease were given lenalidomide maintenance therapy (20 mg for 21 days) until progression. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximabpatients ≥ 75 years old with relapsed Diffuse large B-cell lymphoma will be treated with classical Rituximab-based chemotherapy or Rituximab plus Lenalidomide. | Drug | classical rituximab-based chemotherapy, rituximab plus lenalidomide |
| Lenalidomide 20 MGpatients ≥ 75 years old with relapsed Diffuse large B-cell lymphoma will be treated with Rituximab plus Lenalidomide. Four 28-days cycles of oral Lenalidomide (20 mg / d for 21 days) and Rituximab 375mg/m2 on day 1 and day 21. After this induction phase, patients achieving at least stable disease were given lenalidomide maintenance therapy (20 mg for 21 days) until progression | Drug | rituximab plus lenalidomide |
| Comprehensive Geriatric Assessment (CGA)A comprehensive geriatric assessment (CGA) is recommended by the Société Internationale d'Onco Gériatrie (SIOG) in order to assess all geriatric facets (comorbidity, functional impairment, nutritional status, mental and psychological status, environment,…) on which treatment may impact. | Other | classical rituximab-based chemotherapy, rituximab plus lenalidomide |
| Activities of daily living (ADL) scaleActivities of daily living (ADL) comprise the basic actions that involve caring for one's self and body, including personal care, mobility, and eating. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment. | Other | classical rituximab-based chemotherapy, rituximab plus lenalidomide |
Primary outcome
Progression of free survival at 6 months in elderly patients treated with Rituximab plus Lenalidomide or Rituximab plus chemotherapy.
Time frame: at 6 months
Progression of free survival at 6 months with maintain autonomy without loss of 0.5 point of ADL in elderly patients 75 years old and over with relapsed diffuse large B-cell lymphoma treated with Rituximab plus Lenalidomide or Rituximab plus investigator's choice .
2 secondary outcomes
Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups
Time frame: at 6 months
Overall survival rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups
Time frame: at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederic Peyrade, MD principal investigator
Centre Antoine Lacassagne, Nice
Boulhassass, MD principal investigator
Hopital Cimiez NICE
Soubeyran, Pr principal investigator
Institut Bergonié Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, Lenalidomide 20 MG and Comprehensive Geriatric Assessment (CGA) in people with Chemotherapy and Diffuse Large B-Cell Lymphoma (DLBCL), Nos, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of free survival at 6 months in elderly patients treated with Rituximab plus Lenalidomide or Rituximab plus chemotherapy. (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.