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

  • STATUS
    Recruiting
  • End date
    Jan 15, 2031
  • participants needed
    128
  • sponsor
    Institut Curie
Updated on 27 January 2021
rituximab
vincristine
measurable disease
cell transplantation
gilbert's syndrome
lenalidomide
neutrophil count
b-cell lymphoma
ibrutinib

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).

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

Details
Condition Diffuse Large B-Cell Lymphoma, Central Nervous System Neoplasms
Treatment Ibrutinib, Lenalidomide
Clinical Study IdentifierNCT04446962
SponsorInstitut Curie
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Newly diagnosed Primary Central Nervous System Lymphoma (PCNSL)
Aged between 18 and 60 (18 and 60)
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)
Total bilirubin 1.5 x ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin
Estimated Glomerular Filtration Rate 60 mL/min/1.73m2
Able to swallow capsules
Karnofsky Performance Status (KPS): 40-100% for the phase Ib and no restriction on the KPS for the phase II
Able to understand teratogenic risks of the Lenalidomide and Ibrutinib. Patient must be able to understand and fulfill the Lenalidomide Pregnancy Prevention Plan requirements. This plan may be accepted by the person of confidence in case of impaired cognitive status of the patient
Women of childbearing potential (WCBP) and men who are sexually active must be practicing a highly effective method of birth control. Women should avoid a pregnancy while taking treatment by Lenalidomide or Ibrutinib and for up to 1 month after ending treatment. Men must agree to not to father a child or donate sperm during treatment by Lenalidomide or Ibrutinib and up to 3 months after the last dose of study drug
Women of childbearing potential (WCBP) must have a negative serum (Bta-human Chorionic Gonadotropin (Bta-hCG)) or urine pregnancy test at inclusion
Signed informed consent, which could be signed by a person on confidence in case the neurologic status of the patient does not allow him to understand and/or to sign

Exclusion Criteria

Histology other than DLBCL
Positive HIV serology
Active viral infection with Hepatitis B or C virus
Preexisting immunodeficiency and/or organ transplant recipient
Isolated Central Nervous System (CNS) relapse of systemic Non-Hodgkin's Lymphoma
Prior treatment for PCNSL (except corticosteroids)
Isolated primary vitreo-retinal lymphoma
Major surgery, within 4 weeks prior to the first dose of study drug. Stereotactic biopsy and vitrectomy are not considered major surgery
History of stroke or intracranial hemorrhage (except minor post biopsy hemorrhage) within 6 months prior to inclusion
Requires anticoagulation with warfarin or equivalent vitamin K antagonists
Requires treatment with strong CYP3A4 inhibitors
Pregnancy or lactation
Clinically significant cardiovascular disease
Any other active malignancy, except basocellular carcinoma and non-invasive cervix cancer
Inclusion in another experimental anti-cancer drug therapy
No social security affiliation
Persons under legal protection
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