LOC-R01 Study of Lenalidomide and Ibrutinib in Association With Rituximab-Methotrexate Procarbazine Vincristin (R-MPV)

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).

NCT Number	NCT04446962
Lead Sponsor	Institut Curie Collaborators: National Cancer Institute, France
Conditions	Lymphoma, Large B-Cell, Diffuse, Central Nervous System Neoplasms, Primary
Enrollment	118 participants
Start Date	2020-10-30
Primary Completion	2035-02-02 (estimated)
Study Completion	2035-08-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-25