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Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma

ConditionsRecurrent Diffuse Large B-Cell LymphomaRecurrent Grade 3b Follicular LymphomaRecurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRecurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 RearrangementsRecurrent High Grade B-Cell Lymphoma, Not Otherwise SpecifiedRecurrent Primary Mediastinal Large B-Cell LymphomaRecurrent Transformed Non-Hodgkin LymphomaRefractory Diffuse Large B-Cell LymphomaRefractory Grade 3b Follicular LymphomaRefractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRefractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 RearrangementsRefractory High Grade B-Cell Lymphoma, Not Otherwise SpecifiedRefractory Primary Mediastinal Large B-Cell LymphomaRefractory Transformed Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorYazeed Sawalha

About this trial

This phase Ib/II trial evaluates the safety, optimal dose, and efficacy of the combination of epcoritamab and ibrutinib in treating patients with aggressive B-cell non-Hodgkin lymphoma that has come back (relapsed) or responded to previous treatment (refractory). Epcoritamab, a bispecific antibody, binds to two different types of receptors (proteins present on the cell surface) at the same time. The two receptors that epcoritamab binds to are called CD3 and CD20. CD3 is found on T cells, which are important cells of the immune system that help fight cancer and infections. CD20 is found on the surface of most types of aggressive B-cell non-Hodgkin lymphoma cells. By binding to both CD3 and CD20, epcoritamab brings the two cells close together so the T cells can fight and kill the lymphoma B cells. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, binds to a protein on B cells, a type of white blood cell from which the lymphoma developed. By doing this it decreases the ability of the lymphoma B cells to survive and grow. Ibrutinib may also improve the health (or fitness) of T cells thus making epcoritamab safer and/or more effective.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

One of the following CD20+ B-cell non-Hodgkin lymphoma subtypes (note, documentation of CD20 positivity by flow cytometry and/or immunohistochemistry is based on any representative pathology report)

Diffuse large B-cell lymphoma (DLBCL), including DLBCL, not otherwise specified (NOS); T-cell/histiocyte-rich large B-cell lymphoma; and Epstein-Barr virus-positive DLBCL, NOS

High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangements (double-hit or triple-hit lymphoma) or HGBL, NOS

Primary mediastinal B-cell lymphoma (PMBCL)

Disqualifiers

Prior therapy with a bispecific antibody targeting CD3 and CD20

Prior lymphoma therapy should be completed greater than two weeks before the start of protocol therapy, except for corticosteroids used for palliation of symptoms

Patients who require immediate cytoreductive therapy for their lymphoma per the treating physician's assessment are ineligible

Patients with a history of allogeneic stem cell transplantation are excluded unless the transplant was > 180 days before the first scheduled dose of ibrutinib AND the patient does not have evidence of active acute or chronic graft versus host disease AND the patient must not have taken immunosuppressive medications associated with the transplant for at least 1 month before the first scheduled dose of ibrutinib

Trial design

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Bone Marrow Aspiration

    Procedure/Surgery

    Undergo bone marrow aspiration and biopsy

  • Bone Marrow Biopsy

    Procedure/Surgery

    Undergo bone marrow aspiration and biopsy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT and PET/CT

  • Epcoritamab

    Biological/Vaccine

    Given SC

  • Ibrutinib

    Drug

    Given PO

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

Treatment groups

38 Participants
are divided into 1 treatment group
Group A: Treatment (epcoritamab, ibrutinib)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs)

AEs will be tabulated by type and grade using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 and displayed in summary form. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.

Time frame
Up to 60 days after last dose of study drug
2

Incidence of cytokine release syndrome (CRS)

CRS severity will be graded using American Society for Transplantation and Cellular Therapy Cytokine Release Syndrome criteria. The CRS rate will be calculated together with 95% one-sided confidence intervals among evaluable patients.

Time frame
Up to 60 days after last dose of study drug

Secondary outcomes

1

Overall response rate (ORR)

ORR will be defined as the proportion of patients achieving a complete or partial response and reported with a 95% binomial confidence interval.

Time frame
Up to 24 months
2

Complete response (CR) rate

Time frame
Up to cycle 12 (each cycle is 28 days)
3

Progression-free survival (PFS)

PFS will be defined for all patients who begin treatment therapy to the date of progression or death. PFS will be estimated using the method of Kaplan-Meier, where estimates at time points of interest will be reported with 95% confidence intervals. Median PFS will be evaluated if estimable.

Time frame
From the start of treatment to the time of progression or death, whichever occurs first, assessed up to 5 years
4

Duration of response (DOR)

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

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

Yazeed Sawalha

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

AbbVie

Collaborator

Genmab

Collaborator

Source ClinicalTrials.gov
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