LOC-R01 Study of Lenalidomide and Ibrutinib in Association With Rituximab-Methotrexate Procarbazine Vincristin (R-MPV)
Status:
Recruiting
Trial end date:
2031-01-15
Target enrollment:
Participant gender:
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).