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Epcoritamab in Combination With R-CHOP for Patients With Aggressive Non-Hodgkin Lymphoma

ConditionsNon-Hodgkin's B-cell LymphomaLymphoma Non-HodgkinDiffuse Large B-Cell Lymphoma (DLBCL)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCarrie Ho, MD

About this trial

A Phase II, open-label, two-arm, multicenter study evaluating the combination of epcoritamab with R-CHOP chemotherapy in patients with newly diagnosed, aggressive B-cell non-Hodgkin lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have confirmed CD20-positive aggressive B-cell lymphoma, including de novo or transformed diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement; primary mediastinal large B-cell lymphoma (PMBCL); T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus-positive DLBCL, NOS; or follicular lymphoma grade 3b.

Measurable disease per Lugano 2014 criteria.

No prior therapy for DLBCL or FL G3B other than corticosteroids or palliative radiotherapy. Of note, a cycle of anthracycline-containing regimen (given as standard of care prior to study enrollment) is allowed, provided that patients will receive a total of six cycles of chemotherapy as part of their treatment plan. Patients who received one cycle of an anthracycline-containing regimen prior to enrollment will proceed directly to Cycle 2 on study.

Age ≥18 years

Disqualifiers

History of severe allergic or anaphylactic reactions to anti-CD20 mAb therapy or known allergy or intolerance to any component or excipient of epcoritamab.

Any prior treatment with a bispecific antibody targeting CD3 and CD20.

Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to the first dose of epcoritamab.

Requiring immunosuppressive therapy for an ongoing baseline medical condition. For corticosteroids, prednisolone >10 mg daily (or equivalent) qualifies as immunosuppressive and thus be excluded for this use. Note: corticosteroids at any dose are permitted for control of lymphoma related symptoms, including during screening, and for any adverse events (AE) management during study.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Rituximab, Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisolone (R-CHOP)

    Drug

    Given orally and intravenously (IV)

  • Epcoritamab

    Drug

    Given subcutaneously (SC)

  • Dexamethasone

    Drug

    Given orally

  • Positron Emission Tomography (PET)

    Procedure/Surgery

    Undergo imaging

  • Blood specimen collection

    Procedure/Surgery

    Perform Blood work

  • Questionnaires

    Behavioral

    Participants complete European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

  • Computerized tomography (CT)

    Procedure/Surgery

    Undergo Imaging

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Arm A: Treatment with Standard Dexamethasone (First 6 participants)Experimental treatment 7 interventions
Group B: Arm B: Treatment with Modified DexamethasoneExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Cytokine Release Syndrome (CRS) Rate

The cytokine release syndrome (CRS) rate is defined as the incidence of CRS of any grade during Cycle 2, graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria. The proportion and corresponding 95% confidence interval will be reported.

Time frame
Up to day 42

Secondary outcomes

1

Proportion of Participants with Treatment-emergent Adverse Events

Proportion of participants with treatment-emergent adverse events, classified according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The proportion and 95% confidence interval will be reported.

Time frame
Up to 60 days after treatment
2

Overall Response (OR)

Overall response (OR) is defined as the proportion of treated participants who obtained an radiographic objective response confirmed complete response (CR) or confirmed partial response (PR) per Lugano Classification. The proportion and 95% confidence interval will be reported.

Time frame
Up to 2 years
3

Duration of Overall Response

Duration of overall response is defined as the time from first documentation of complete response (CR) or partial response (PR) to the first occurrence of disease progression, recurrence, or death, whichever occurs first. Patients without progression who are alive at the clinical cutoff will be censored at the date of their last disease assessment. Median, estimates and 95% confidence interval will be reported using the Kaplan-Meier method and Brookmeyer and Crowley method.

Time frame
Up to 2 years
4

Median Progression-Free Survival (PFS)

Progression-free survival (PFS) is the time from the first dose of treatment until disease progression or death, whichever occurs first. If neither event occurs, PFS is measured up to the last adequate disease assessment. If a patient is alive but has no tumor assessments after starting treatment, PFS is measured up to the first dose date. Median, estimates and 95% confidence interval will be reported using the Kaplan-Meier method and Brookmeyer and Crowley method.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

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

Carrie Ho, MD

Lead sponsor

University of California, San Francisco

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: