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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)

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ClinicalTrials.gov Identifier: NCT04113226
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : July 30, 2021
Sponsor:
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
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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.


Condition or disease Intervention/treatment Phase
Chemotherapy Diffuse Large B-Cell Lymphoma (DLBCL), Nos Elderly Drug: Rituximab Drug: Lenalidomide 20 MG Other: Comprehensive Geriatric Assessment (CGA) Other: Activities of daily living (ADL) scale Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 26, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024


Arm Intervention/treatment
Active Comparator: classical rituximab-based chemotherapy
Rituximab-based physician's choice chemotherapy
Drug: Rituximab
patients ≥ 75 years old with relapsed Diffuse large B-cell lymphoma will be treated with classical Rituximab-based chemotherapy or Rituximab plus Lenalidomide.

Other: 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: Activities of daily living (ADL) scale
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.

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

Drug: Lenalidomide 20 MG
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

Other: 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: Activities of daily living (ADL) scale
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 Measures :
  1. 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 .


Secondary Outcome Measures :
  1. Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups [ Time Frame: at 6 months ]
    Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups

  2. Overall survival rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups [ Time Frame: at 6 months ]
    Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04113226


Contacts
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Contact: Caroline Delette, MD +33 3 22 45 59 14 delette.caroline@chu-amiens.fr
Contact: Annabelle BOUSSAULT +33 3 +33 3 22 45 59 14 boussault.annabelle@chu-amiens.fr

Locations
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France
CHU Amiens Recruiting
Amiens, France, 80054
Contact: Caroline Delette, MD       delette.caroline@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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
Investigators
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Principal Investigator: Frederic Peyrade, MD Centre Antoine Lacassagne NICE
Principal Investigator: Boulhassass, MD Hopital Cimiez NICE
Principal Investigator: Soubeyran, Pr Institut Bergonié Bordeaux
Principal Investigator: Philippe Caillet, MD Hôpital Henri Mondor, APHP CRETEIL
Principal Investigator: Fabrice Jardin, MD Centre Henri Becquerel, ROUEN
Principal Investigator: Pascal Chaibi, MD Hôpital Charles Foix, APHP IVRY/SEINE
Principal Investigator: Catherine Thieblemont, MD Hôpital Saint-louis, APHP, PARIS
Principal Investigator: Damaj, MD Centre Hospitalier Universitaire CAEN
Principal Investigator: Garidi, MD Centre Hospitalier SAINT-QUENTIN
Principal Investigator: Leduc, MD Centre Hospitalier ABBEVILLE
Principal Investigator: Dennetière, MD Centre Hospitalier COMPIEGNE
Principal Investigator: Ivanoff, MD Hôpital Avicenne, APHP BOBIGNY
Principal Investigator: Isabelle Grulois, MD CH Saint Malo
Principal Investigator: Margot Robles, MD CH Périgueux
Principal Investigator: Caroline DELETTE, PhD CHU Amiens Picardie
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT04113226    
Other Study ID Numbers: PI2018_843_0051
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: July 30, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire, Amiens:
chemotherapy
Diffuse large B cell lymphoma (DLBCL)
Relapse
activities of patients daily living
Elderly
Lenalidomide
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Lenalidomide
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors