Because Primary Central Nervous System Lymphoma (PCNSL) are mainly diffuse large B-cell lymphoma of the activated B cells (ABC) type, the investigators hypothesize that the synergy of lenalidomide with rituximab shown in systemic non-Hodgkin's lymphoma (NHL) could be observed in PCNSL. This study will assess the efficiency of the the combination of lenalidomide and rituximab in relapsed/refractory PCNSL, and the efficiency of a maintenance treatment with lenalidomide alone in maintaining the response.
The investigators use a two-stage Fleming's design based on the following hypotheses under treatment: 10% (null hypothesis, minimal clinical benefit rate), 30% (alternative hypothesis, acceptable clinical benefit rate), 3% type I error rate, 5% type II error rate. Under these hypotheses, a total of 45 assessable patients will be necessary: 22 for the first stage + 23 for the second stage. Stage 1: following the inclusion of the first 22 assessable patients, if 0 or 1 patient has an objective response (CR, Complete Response + uCR, unconfirmed Complete Response + PR, Partial Response) at the end of induction treatment, the study would be terminated early and the treatment will be considered ineffective. If 2 or more patients have an objective response at the end of induction treatment, then the treatment will be considered as effective in this indication. Otherwise, the second group of 23 patients will be recruited. Stage 2: if at the end of recruitment, 8 or less patients have an objective response, the investigators will conclude to inefficacy, and if 9 or more patients have an objective response, then the treatment will be considered as effective and need further exploration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Centre Léon Bérard
Lyon, Auvergne-Rhône-Alpes, France
CHU Estaing
Clermont-Ferrand, Auvergne, France
CHU Bretonneau - Centre Henry Kaplan
Tours, Centre-Val de Loire, France
Assess the efficacy of lenalidomide in combination with rituximab in relapsed/refractory PCNSL as measured by the objective response rate (CR + uCR + PR) at the end of the 8 cycles of induction therapy.
The objective response rate (CR+uCR+PR) will be evaluated according to the IPCG (International Primary CNS lymphoma Collaborative Group) recommendations. Patients will have an cerebral MRI, an ophthalmological examination and a lumbar puncture at several times.
Time frame: 33 months
The safety of the association during induction and maintenance therapy in a population of PCNSL (NCI V4)
Time frame: 56 months
The duration of response
Time frame: 56 months
Progressive Free Survival at one year from the date of inclusion to the date of progression of the disease or death
Time frame: 56 months
Overall Survival from the date of inclusion to the date of death
Time frame: 56 months
Quality of life using QLQ-C30 EORTC (European Organization for Research and Treatment of Cancer) questionnaire
Time frame: 20 months
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Institut Bergonié
Bordeaux, Gironde, France
Chu Michallon
Grenoble, Isère, France
Hôpital Central
Nancy, Lorraine, France
CHRU Lille - Hôpital Claude Huriez
Lille, Nord, France
Centre Henri Becquerel
Rouen, Seine Maritime, France
CHU Amiens -Hôpital Sud
Amiens, Somme, France
Chu La Timone
Marseille, France
...and 2 more locations