Efficacy of Lenalidomide With Rituximab in Refractory or Relapse of Primary Central Nervous System Lymphoma (REVRI)
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|ClinicalTrials.gov Identifier: NCT01956695|
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : July 10, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Relapse||Drug: Lenalidomide Drug: Rituximab||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Evaluating the Efficacy of Lenalidomide in Association With Rituximab in Refractory or Relapse of Primary Central Nervous System Lymphoma (PCNSL)|
|Actual Study Start Date :||September 18, 2013|
|Actual Primary Completion Date :||January 11, 2018|
|Actual Study Completion Date :||January 11, 2018|
Experimental: Lenalidomide & Rituximab
Induction treatment : Lenalidomide 20 mg capsule on days 1 to 21 days of a 28 days cycle for the first cycle followed by 25 mg on daily on days 1 to 21 of a 28 days cycle for cycles 2 to 8 (in the absence of hematologic toxicity. Rituximab at day 1 of each induction course 375 mg/m² intravenous.
Maintenance : Lenalidomide 10 mg capsule on days 1 to 21 days of a 28 days cycle for 1 year or until progression or intolerance.
Other Name: Revlimid®
Other Name: Mabthera®
- 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. [ Time Frame: 33 months ]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.
- 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 ]
- Exploration of T cells and NK (Natural Killer) cells populations in PCNSL before and after treatment to correlate possible changes of these populations with therapeutic response [ Time Frame: 33 months ]Pilot exploration of T cells and NK cells populations in PCNSL before and after treatment with the combination of lenalidomide-rituximab and to correlate possible changes of these populations with therapeutic response
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): NCT01956695
|Clermont-Ferrand, Auvergne, France, 63003|
|CHU Bretonneau - Centre Henry Kaplan|
|Tours, Centre, France, 37044|
|Bordeaux, Gironde, France, 33076|
|Hôpital de la Pitié Salpétrière|
|Paris, Ile De France, France, 75013|
|Institut curie - Hôpital René Huguenin|
|Saint-Cloud, Ile De France, France, 92210|
|Grenoble, Isère, France, 38043|
|Nancy, Lorraine, France, 54036|
|CHRU Lille - Hôpital Claude Huriez|
|Lille, Nord, France, 59037|
|Centre Léon Bérard|
|Lyon, Rhône-Alpes, France, 39373|
|Centre Henri Becquerel|
|Rouen, Seine Maritime, France, 76038|
|CHU Amiens -Hôpital Sud|
|Amiens, Somme, France, 80054|
|Chu La Timone|
|Marseille, France, 13005|
|Principal Investigator:||Carole SOUSSAIN, MD||Institut Curie - Hopital Rene Huguenin|