A Phase Ib Trial With Dose Expansion of Epcoritamab in Combination With Ibrutinib in Refractory/Recurrent CNS Lymphoma (EIFEL-Trial)
Memorial Sloan Kettering Cancer Center
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 d…
Interventions
- Drugibrutinib
Ibrutinib should be self-administered daily by the participant and should be taken at approximately the same time each day
- DrugEpcoritamab
Epcoritamab will be administered at the study site clinic, as a SC injection
Locations (8)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Commack (Limited Protocol Activities)Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York