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

Sponsor
Institut Curie
Study ID
NCT04446962
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Central Nervous System Neoplasms, Primary
  • Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Lenalidomide — DRUG
    Patients will receive 4 cycles of induction chemotherapy with R-MPV + Lenalidomide using the Maximum Tolerated Dose (MTD) of Lenalidomide and Ibrutinib as determined in the phase-Ib part of the study.
  • Ibrutinib — DRUG
    Patients will receive 4 cycles of induction chemotherapy with R-MPV + Ibrutinib, using the Maximum Tolerated Dose (MTD) of Lenalidomide and Ibrutinib as determined in the phase-Ib part of the study.

Study Details

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).

Key Dates

Start date
Oct 30, 2020
Status verified
Sep 2025
Primary completion
Feb 2, 2035
Completion
Aug 30, 2035

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: R-MPV with Lenalidomide
    Lenalidomide in association with R-MPV as a targeted induction treatment
  • Active Comparator: Arm B: R-MPV with Ibrutinib
    Ibrutinib in association with R-MPV as a targeted induction treatment

Primary Outcome Measure

Dose Limiting Toxicity (DLT) during the first cycle of treatment for each treatment arm. [ Time Frame: 1 month ]

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