Status:
ACTIVE_NOT_RECRUITING
LOC-R01 Study of Lenalidomide and Ibrutinib in Association With Rituximab-Methotrexate Procarbazine Vincristin (R-MPV)
Lead Sponsor:
Institut Curie
Collaborating Sponsors:
National Cancer Institute, France
Conditions:
Lymphoma, Large B-Cell, Diffuse
Central Nervous System Neoplasms, Primary
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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-Procarbazin...
Detailed 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 (H...
Eligibility Criteria
Inclusion
- 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)
- 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: 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 (beta-human chorionic gonadotropin \[B-hCG\]) 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
- 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.
Key Trial Info
Start Date :
October 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2035
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04446962
Start Date
October 30 2020
End Date
August 30 2035
Last Update
September 25 2025
Active Locations (28)
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1
CHU Amiens
Amiens, France
2
CHU Angers
Angers, France
3
CH côte Basque
Bayonne, France, 64100
4
CHU Besançon
Besançon, France