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Study of Epcoritamab in R/R Primary Diffuse Large B-cell Lymphoma of the CNS Treated With Lenalidomide and Rituximab

ConditionPrimary CNS Lymphoma (PCNSL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Lymphoma Academic Research Organisation

About this trial

The purpose of this phase 2 study is to evaluate the efficacy and safety of epcoritamab in subjects with relapsed or refractory primary diffuse large B-cell lymphoma of the Central Nervous System treated with rituximab and lenalidomide.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject (or their legally acceptable representative/trusted person) who understand and voluntarily signs and dates an informed consent form prior to any study-specific assessments/procedures being conducted.

Subject ≥ 18 years old at the time of signing the informed consent form (ICF)

Confirmed histology of primary diffuse large B-cell lymphoma of the CNS (according to the 2022 WHO classification) or confirmed cytology of primary vitreoretinal diffuse large B-cell lymphoma, with CD20 positivity in immunohistochemical staining or flow cytometry at any point in the disease history.

Subjects with relapsed or refractory (R/R) PCNSL or PVRL after at least one line of systemic therapy. Subject with R/R PCNSL must have previously received at least high dose methotrexate. Subject with R/R PVRL must have received either intravenous high dose methotrexate or intraocular methotrexate (PVRL cohort). Subjects can have received radiotherapy or intensive chemotherapy with hematopoietic stem cell rescue as part of treatment of the PCNSL or PVRL.

Disqualifiers

T-cell lymphoma.

Cerebral localization of a systemic lymphoma.

Prior history of organ transplantation or other cause of severe immunodeficiency.

Known Human Immunodeficiency Virus (HIV) or Positive HTLV1 serology.

Trial design

Design model

Single group

Treatments tested in this trial

  • Epcoritamab

    Drug

    Epcoritamab Investigational Medicinal Product (IMP): Epcoritamab will be used during induction phase and Maintenance phase.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: experimental/epcoritamabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The best Objective Response rate (ORR) in the R/R PCNSL cohort

Objective Response rate

Time frame
after 8 months or before in case of permanent treatment discontinuation

Secondary outcomes

1

Objective response rate (CR + CRu + PR)

Objective response rate

Time frame
after 8 months or before in case of permanent treatment discontinuation
2

Best objective response rate (CR + CRu + PR) in the PVRL cohort

Objective response rate

Time frame
after 8 months or before in case of permanent treatment discontinuation
3

Objective response rate (CR + CRu + PR) in the PVRL cohort

Objective response rate

Time frame
after 8 months or before in case of permanent treatment discontinuation
4

Best complete response rate (CR+CRu)

Best complete response rate

Time frame
after 8 months or before in case of permanent treatment discontinuation

Other outcomes

Sponsors and contacts

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

The Lymphoma Academic Research Organisation

Lead sponsor

AbbVie

Collaborator

Source ClinicalTrials.gov
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