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Spots Global Cancer Trial Database for LOC-R01 Study of Lenalidomide and Ibrutinib in Association With Rituximab-Methotrexate Procarbazine Vincristin (R-MPV)

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Trial Identification

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

Study Description

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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Steven LE GOUILL, PhD

Affiliation: Institut Curie

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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