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Low Dose Epcoritamab Plus GemOx in R/R DLBCL

ConditionRelapsed/Refractory Diffuse Large B Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHospital Universitario Dr. Jose E. Gonzalez

About this trial

In this study, researchers are looking to determine whether Gemcitabine/Oxaliplatin plus a lower dose of Epcoritamab (12 mg) works to treat subjects with relapsed/refractory diffuse large B-cell lymphoma, who are candidates to autologous stem cell transplantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects with relapsed/refractory diffuse large B-cell lymphoma who have received at least 1 previous line of treatment and that are candidates to autologous stem cell transplant

ECOG 0-2

Women of reproductive age who agree on getting a contraceptive method

Subjects who fulfill Lugano´s criteria for disease activity

Disqualifiers

Active bacterial, viral or fungal infection

Subjects who have already received an autologous o allogeneic stem cell transplantation

Subjects with other active neoplasias

Subjects with end-stage failure

Trial design

Design model

Single group

Treatments tested in this trial

  • Epcoritamab

    Drug

    Subjects will receive 2 step up doses of Epcoritamab (0.16 mg and 0.8 mg) followed by 12 mg weekly, for a total of three 21-day cycles (8 applications)

  • Gemcitabine (1000 mg/m2)

    Drug

    Subjects will receive gemcitabine 1000 mg/m2 on days 1 and 15 of the three 21-day cycles.

  • Oxaliplatin

    Drug

    Subjects will receive oxaliplatin 100 mg/m2 on day 1 of three 21-day cycles.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Epcoritamab + GemOxExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Determine ORR and CR after GemOx plus low-dose Epcoritamab

Determine ORR and CR after 3 cycles of GemOx plus low-dose Epcoritamab based on PET-CT

Time frame
From enrollment to the end of treatment at 14 weeks

Secondary outcomes

1

Establish feasibility

Determine the number of subjects that complete the first cycle without need for hospitalization

Time frame
From enrollment up to day 29
2

Describe cytokine release syndrome incidence

Describe the number of subjects who develop grade 2-4 cytokine release syndrome during the first cycle of treatment

Time frame
From day 1 up to day 29
3

Describe immune effector cell- associated neurotoxicity syndrome incidence

Describe the number of subjects that develop immune effector cell-associated neurotoxicity syndrome

Time frame
From day 1 up to week 10
4

Describe adverse events

Describe the number of subjects that develop any adverse events

Time frame
From day 1 up to week 10

Other outcomes

Sponsors and contacts

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

Hospital Universitario Dr. Jose E. Gonzalez

Lead sponsor

Source ClinicalTrials.gov
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