Spots Global Cancer Trial Database for 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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Trial Identification
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
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 ID: NCT04113226
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.
Detailed Description:
Eligibility
Minimum Age: 75 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHU Amiens, Amiens, , France
Contact Details
Name: Frederic Peyrade, MD
Affiliation: Centre Antoine Lacassagne NICE
Role: PRINCIPAL_INVESTIGATOR
Name: Boulhassass, MD
Affiliation: Hopital Cimiez NICE
Role: PRINCIPAL_INVESTIGATOR
Name: Soubeyran, Pr
Affiliation: Institut Bergonié Bordeaux
Role: PRINCIPAL_INVESTIGATOR
Name: Philippe Caillet, MD
Affiliation: Hôpital Henri Mondor, APHP CRETEIL
Role: PRINCIPAL_INVESTIGATOR
Name: Fabrice Jardin, MD
Affiliation: Centre Henri Becquerel, ROUEN
Role: PRINCIPAL_INVESTIGATOR
Name: Pascal Chaibi, MD
Affiliation: Hôpital Charles Foix, APHP IVRY/SEINE
Role: PRINCIPAL_INVESTIGATOR
Name: Catherine Thieblemont, MD
Affiliation: Hôpital Saint-louis, APHP, PARIS
Role: PRINCIPAL_INVESTIGATOR
Name: Damaj, MD
Affiliation: Centre Hospitalier Universitaire Caen
Role: PRINCIPAL_INVESTIGATOR
Name: Garidi, MD
Affiliation: Centre Hospitalier SAINT-QUENTIN
Role: PRINCIPAL_INVESTIGATOR
Name: Leduc, MD
Affiliation: Centre Hospitalier Abbeville
Role: PRINCIPAL_INVESTIGATOR
Name: Dennetière, MD
Affiliation: Centre Hospitalier COMPIEGNE
Role: PRINCIPAL_INVESTIGATOR
Name: Ivanoff, MD
Affiliation: Hôpital Avicenne, APHP BOBIGNY
Role: PRINCIPAL_INVESTIGATOR
Name: Isabelle Grulois, MD
Affiliation: CH Saint Malo
Role: PRINCIPAL_INVESTIGATOR
Name: Margot Robles, MD
Affiliation: CH Périgueux
Role: PRINCIPAL_INVESTIGATOR
Name: Caroline DELETTE, PhD
Affiliation: CHU Amiens Picardie
Role: PRINCIPAL_INVESTIGATOR
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