Phase 2 Trial of Epcoritamab in Combination With Rituximab-mini CVP for Older Unfit/Frail Patients or Anthracycline-Ineligible Adult Patients With Newly Diagnosed Diffuse Large B-cell Lymphoma

ConditionLarge B-cell Lymphoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

To learn if adding epcoritamab to the treatment combination R-miniCVP (rituximab, cyclophosphamide, vincristine, prednisone) can help to control newly diagnosed DLBCL. The safety of this combination will also be studied.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Histologically diagnosed

Diffuse large B-cell lymphoma, not otherwise specified (NOS) or

High grade B-cell lymphoma (NOS or MYC and BCL2 rearrangements) or

Disqualifiers

Known central nervous system lymphoma or leptomeningeal disease

Adequately treated localized skin cancer without evidence of disease.

Adequately treated cervical carcinoma in situ without evidence of disease.

Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at undue risk.

Trial design

Design model

Single group

Treatments tested in this trial

Prednisone
Drug
Given by IV (vein)
Rituximab
Drug
Given by IV (vein)
Cyclophosphamide
Drug
Given by IV (vein)
Vincristine
Drug
Given by IV (vein)
Epcoritamab
Drug
Given under the skin

Treatment groups

40 Participants

are divided into 1 treatment group

Group A: R-miniCVP+ EpcoritamabExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Time frame

through study completion: an average of 1 year

Sponsors and contacts

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

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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