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A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL)

ConditionsPrimary Central Nervous System Lymphoma (PCNSL)Primary Central Nervous System LymphomaRelapsed Primary Central Nervous System LymphomaRefractory Primary Central Nervous System LymphomaCentral Nervous System LymphomaSecondary Central Nervous System LymphomaSecondary Central Nervous System Lymphoma (SCNSL)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

>/= 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.

Absolute neutrophil count (ANC) ≥ 1 x 109/L

Disqualifiers

Newly diagnosed PCNSLs or SCNSLs and patients with non-CNS disease are excluded.

Patients with existing chronic moderate and severe hepatic impairment (Child-Pugh class B or C) are excluded

Patient is concurrently using other approved or investigational antineoplastic agents.

Patient has an active concurrent malignancy requiring active therapy

Trial design

Design model

Sequential

Treatments tested in this trial

  • ibrutinib

    Drug

    Ibrutinib should be self-administered daily by the participant and should be taken at approximately the same time each day

  • Epcoritamab

    Drug

    Epcoritamab will be administered at the study site clinic, as a SC injection

Treatment groups

26 Participants
are divided into 3 treatment groups
Group A: Cohort AExperimental treatment 2 interventions
Group B: Cohort B1Experimental treatment 2 interventions
Group C: Cohort B2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of dose limiting toxicities/DLTs

Cohort A - To determine the safety and tolerability of epcoritamab in combination with ibrutinib in CNS lymphoma patients

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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