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| Name | Class |
|---|---|
| cimiez hospital Nice | UNKNOWN |
| Institut Bergonié | OTHER |
| groupe hospitalier public sud de l'oise | UNKNOWN |
| Henri Mondor University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| classical rituximab-based chemotherapy | Active Comparator | Rituximab-based physician's choice chemotherapy |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | patients ≥ 75 years old with relapsed Diffuse large B-cell lymphoma will be treated with classical Rituximab-based chemotherapy or Rituximab plus Lenalidomide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 . | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups | Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups | at 6 months |
| Overall survival rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 de Caen | Principal Investigator |
| Garidi, MD | Centre Hospitalier SAINT-QUENTIN | Principal Investigator |
| Leduc, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | 80054 | France |
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| OTHER |
| Centre Henri Becquerel | OTHER |
| Hôpital Charles Foix | OTHER |
| Saint-Louis Hospital, Paris, France | OTHER |
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| Lenalidomide 20 MG | Drug | 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) scale | Other | 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. |
|
Response rate in Rituximab plus Lenalidomide and Rituximab plus chemotherapy groups |
| at 6 months |
| 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 | Principal Investigator |
| ID | Term |
|---|---|
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D015620 | Histiocytic Disorders, Malignant |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D015614 | Histiocytosis |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000077269 | Lenalidomide |
| D015577 | Geriatric Assessment |
| D000203 | Activities of Daily Living |
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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