A Trial to Compare Ibrutinib Versus Lenalidomide in Combination With MRE-chemotherapy for Adult P… (NCT04129710) | Clinical Trial Compass
UnknownPhase 2
A Trial to Compare Ibrutinib Versus Lenalidomide in Combination With MRE-chemotherapy for Adult Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL)
China120 participantsStarted 2020-01-01
Plain-language summary
This is a open-label，multicenter, randomised, three-arm, phase II efficacy and safety study of ibrutinib in combination with MRE(methotrexate,rituximab,etoposide)-chemotherapy versus lenalidomide in combination with MRE-chemotherapy given to adult patients who have recurrent/refractory primary central nervous system lymphoma (PCNSL)
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Participants must be able to understand and be willing to sign a written informed consent document.
✓. Men and woman who are 18-75 years old on the day of consenting to the study.
✓. Histologically documented PCNSL and histologically documented systemic diffuse large B-cell lymphoma (DLBCL).
✓. Patients must have relapsed/refractory PCNSL or relapsed/refractory SCNSL
✓. All patients need to have received at least one prior CNS directed therapy. There is no restriction on the number of recurrences.
✓. Patients with parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head CT) 21 days prior to study registration.
✓. Participants must have an ECOG performance status of 0-3.
✓. Participants must have adequate bone marrow and organ function shown by:
Exclusion criteria
✕. Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded.
✕. Patient has received chemotherapy, monoclonal antibodies or targeted anticancer therapy ≤ 4 weeks or 5 half-lives, whichever is shorter, or 6 weeks for nitrosourea or mitomycin-C prior to starting the study drug, or the patient has not recovered from the side effects of such therapy.
✕. Patient has received external beam radiation therapy to the CNS within 21 days of the first dose of the study drug.
What they're measuring
1
Progression-free survival (PFS)
Timeframe: assessed up to 2 yrs
Trial details
NCT IDNCT04129710
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
✕. Patient requires more than 8 mg of dexamethasone daily or the equivalent
✕. Patient has an active concurrent malignancy requiring active therapy
✕. The patient has been treated with radio- or toxin-immunoconjugates within 70 days of the first Patient is allergic to components of the study drug.
✕. Patient is using warfarin or any other Coumadin-derivative anticoagulant or vitamin K antagonists. Patients must be off warfarin-derivative anticoagulants for at least seven days prior to starting the study drug. Low molecular weight heparin is allowed. Patients with congenital bleeding diathesis are excluded.
✕. Patient is taking a drug known to be a moderate and strong inhibitor or inducers of the P450 isoenzyme CYP3A. Participants must be off P450/CYP3A inhibitors and inducers for at least two weeks prior to starting the study drug.