LOC-R01 Study of Lenalidomide and Ibrutinib in Association With Rituximab-Methotrexate Procarbazi… (NCT04446962) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
LOC-R01 Study of Lenalidomide and Ibrutinib in Association With Rituximab-Methotrexate Procarbazine Vincristin (R-MPV)
France118 participantsStarted 2020-10-30
Plain-language 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).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Newly diagnosed Primary Central Nervous System Lymphoma (PCNSL).
✓. a) Aged between 18 and 60 (\>18 and \< 60) - phase IB b) Aged between 18 and 65 (≥ 18 and ≤ 65) - phase II.
✓. Histological confirmed diagnosis of Primary central nervous system lymphoma of Diffuse Large B-Cell Lymphomas (DLBCL) type OR patients with a measurable typical cerebral lesion on MRI with a diagnosis made by cytology and/or by flow cytometry on the vitreous or on the cerebral spinal fluid.
✓. Measurable lesion on MRI with gadolinium enhancement.
✓. Adequate hematological, renal and hepatic function (Laboratory Parameters realized within 14 days before inclusion):
✓. Absolute neutrophil count (ANC) \>1000/mm3
✓. Platelets \> 100,000/mm3 independent of transfusion support
✓. Alanine aminotransferase and aspartate aminotransferase ≤ 3 x Upper Limit of Normal (ULN)
Exclusion criteria
✕
What they're measuring
1
Dose Limiting Toxicity (DLT) during the first cycle of treatment for each treatment arm.
Timeframe: 1 month
2
Complete Response (CR) rate including unconfirmed Complete Response (uCR) at the end of the 4 cycles of induction therapy