A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL) (NCT07082868) | Clinical Trial Compass
RecruitingPhase 1
A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL)
United States26 participantsStarted 2025-08-13
Plain-language summary
The purpose of this study is to find out whether the combination of epcoritamab and ibrutinib is a safe treatment approach that causes few or mild side effects in people with relapsed/refractory primary central nervous system lymphoma (PCNSL) or secondary central nervous system lymphoma (SCNSL).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* \>/= 18 years of age on the day of consenting to the study.
* Histologically documented DLBCL at enrolling institution (biopsy or CSF samples in PCNSL; biopsy of CNS or non-CNS sample in SCNSL)
* Participants must have an ECOG performance status of 0, 1, or 2.
* Participants must have adequate bone marrow and organ function shown by:
* Absolute neutrophil count (ANC) ≥ 1 x 109/L
* Platelets ≥ 75 x 109/L and no platelet transfusion within the past 21 days prior to study consent
* Hemoglobin (Hgb) ≥ 8 g/dL and no red blood cell (RBC) transfusion within the past 21 days prior to study consent
* International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal (unless receiving anticoagulation)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal
* Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome.
* Creatinine clearance (CLCr) ≥ 30 ml/min (based on the following formular Creatinine clearance= ((140-age)\*wt)/(creatinine\*72); multiply by 0.85 for women)
* Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 30 days after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception dur…