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Brief Title: LOC-R01 Study of Lenalidomide and Ibrutinib in Association With Rituximab-Methotrexate Procarbazine Vincristin (R-MPV)
Official Title: LOC-R01: Randomized Phase IB/II Study of Escalating Doses of Lenalidomide and Ibrutinib in Association With R-MPV as a Targeted Induction Treatment for Patients Aged 18 to 60 (up to 65 for Phase II) With a Newly Diagnosed Primary Central Nervous System Lymphoma
Study ID: NCT04446962
Brief Summary: This study is to improve the first-line induction chemotherapy, by combining either Ibrutinib, or Lenalidomide, to a conventional immuno- chemotherapy of R-MPV type (Rituximab-Methotrexate-Procarbazine-Vincristine). This is a randomized Phase II trial, preceded by a dose escalation phase Ib. The objective of the phase Ib is to rule out any limiting toxicity of the new treatment associations, and to determine the recommended dose of Lenalidomide and Ibrutinib to be used in the phase II. In the phase II study, patients will receive 4 cycles of R-MPV + Lenalidomide or 4 cycles of R-MPV + Ibrutinib. The therapeutic response will be evaluated after the 2nd and the 4th cycle. Patients in good therapeutic response will proceed to the consolidation phase with Autologous Stem Cell Transplantation (ASCT).
Detailed Description: The objective of this proposal is to test the feasibility and efficacy of two targeted induction chemotherapies obtained by adding either Lenalidomide or Ibrutinib to a standard Rituximab-High Dose (HD) Methotrexate (MTX) based induction chemotherapy regimen. The R-MPV regimen is chosen as the backbone chemotherapy because of its wide use with robust reproducible results and a good and manageable toxicity profile
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CHU Amiens, Amiens, , France
CHU Angers, Angers, , France
CH côte Basque, Bayonne, , France
CHU Besançon, Besançon, , France
Institut Bergonié, Bordeaux, , France
CHU Caen, Caen, , France
CHU Clermont-Ferrand, Clermont-Ferrand, , France
CH Colmar, Colmar, , France
CHU Créteil, Créteil, , France
CHU Dijon, Dijon, , France
CHU Grenoble, Grenoble, , France
CHRU Lille, Lille, , France
CHU Limoges, Limoges, , France
CHU Lyon, Lyon, , France
CHU La Timone Marseille, Marseille, , France
CHU Nancy, Nancy, , France
CHU Nantes, Nantes, , France
Centre Lacassagne, Nice, , France
CHU Nîmes - Carémeau, Nîmes, , France
Institut Curie, Paris, , France
Hôpital Cochin, Paris, , France
CHU Pitié-Salpêtrière, Paris, , France
CHU Poitiers, Poitiers, , France
CHU Rennes, Rennes, , France
Centre Henri Becquerel, Rouen, , France
CHU de La Réunion, Saint Denis De La Reunion, , France
institut de Cancérologie de Strasbourg, Strasbourg, , France
IUCT -Oncopole, Toulouse, , France
CHU Tours, Tours, , France
Name: Steven LE GOUILL, PhD
Affiliation: Institut Curie
Role: STUDY_DIRECTOR