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Assessment of Survival and Autonomy With Rituximab Plus Chemotherapy or Rituximab Plus Lenalidomide for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma (Relyage)

Primary Purpose

Chemotherapy, Diffuse Large B-Cell Lymphoma (DLBCL), Nos, Elderly

Status

Recruiting

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Rituximab

Lenalidomide 20 MG

Comprehensive Geriatric Assessment (CGA)

Activities of daily living (ADL) scale

About this trial

This is an interventional treatment trial for Chemotherapy focused on measuring chemotherapy, Diffuse large B cell lymphoma (DLBCL), Relapse, activities of patients daily living, Elderly, Lenalidomide

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

classical rituximab-based chemotherapy

rituximab plus lenalidomide

Arm Description

Rituximab-based physician's choice chemotherapy

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.

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups

Overall survival rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups

Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups

Full Information

NCT ID

NCT04113226

First Posted

October 1, 2019

Last Updated

February 7, 2023

Sponsor

Centre Hospitalier Universitaire, Amiens

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

1. Study Identification

Unique Protocol Identification Number

NCT04113226

Brief Title

Assessment of Survival and Autonomy With Rituximab Plus Chemotherapy or Rituximab Plus Lenalidomide for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma

Acronym

Relyage

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 26, 2021 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire, Amiens

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy, Diffuse Large B-Cell Lymphoma (DLBCL), Nos, Elderly

Keywords

chemotherapy, Diffuse large B cell lymphoma (DLBCL), Relapse, activities of patients daily living, Elderly, Lenalidomide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

classical rituximab-based chemotherapy

Arm Type

Active Comparator

Arm Description

Rituximab-based physician's choice chemotherapy

Arm Title

rituximab plus lenalidomide

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Rituximab

Intervention Description

patients ≥ 75 years old with relapsed Diffuse large B-cell lymphoma will be treated with classical Rituximab-based chemotherapy or Rituximab plus Lenalidomide.

Intervention Type

Drug

Intervention Name(s)

Lenalidomide 20 MG

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Comprehensive Geriatric Assessment (CGA)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Activities of daily living (ADL) scale

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression of free survival at 6 months in elderly patients treated with Rituximab plus Lenalidomide or Rituximab plus chemotherapy.

Description

Time Frame

at 6 months

Secondary Outcome Measure Information:

Title

Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups

Description

Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups

Time Frame

at 6 months

Title

Overall survival rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups

Description

Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups

Time Frame

at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Caroline Delette, MD

Phone

+33 3 22 45 59 14

delette.caroline@chu-amiens.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Annabelle BOUSSAULT

Phone

+33 3 +33 3 22 45 59 14

boussault.annabelle@chu-amiens.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederic Peyrade, MD

Organizational Affiliation

Centre Antoine Lacassagne NICE

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Boulhassass, MD

Organizational Affiliation

Hopital Cimiez NICE

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Soubeyran, Pr

Organizational Affiliation

Institut Bergonié Bordeaux

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Philippe Caillet, MD

Organizational Affiliation

Hôpital Henri Mondor, APHP CRETEIL

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fabrice Jardin, MD

Organizational Affiliation

Centre Henri Becquerel, ROUEN

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Pascal Chaibi, MD

Organizational Affiliation

Hôpital Charles Foix, APHP IVRY/SEINE

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Catherine Thieblemont, MD

Organizational Affiliation

Hôpital Saint-louis, APHP, PARIS

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Damaj, MD

Organizational Affiliation

Centre Hospitalier Universitaire CAEN

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Garidi, MD

Organizational Affiliation

Centre Hospitalier SAINT-QUENTIN

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Leduc, MD

Organizational Affiliation

Centre Hospitalier Abbeville

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dennetière, MD

Organizational Affiliation

Centre Hospitalier COMPIEGNE

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ivanoff, MD

Organizational Affiliation

Hôpital Avicenne, APHP BOBIGNY

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Isabelle Grulois, MD

Organizational Affiliation

CH Saint Malo

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Margot Robles, MD

Organizational Affiliation

CH Périgueux

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Caroline DELETTE, PhD

Organizational Affiliation

CHU Amiens Picardie

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Amiens

City

Amiens

ZIP/Postal Code

80054

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caroline Delette, MD

delette.caroline@chu-amiens.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Assessment of Survival and Autonomy With Rituximab Plus Chemotherapy or Rituximab Plus Lenalidomide for Elderly Patients With Relapsed Diffuse Large B-cell Lymphoma

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