RecruitingPhase 2NCT07451652

Low Dose Epcoritamab Plus GemOx in R/R DLBCL

Low Dose Epcoritamab Plus Gemcitabine/Oxaliplatin in Treatment of Transplant Eligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma


Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Enrollment

10 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

  • 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
  • Subjects who voluntarily accept to participate in this study

Exclusion Criteria4

  • 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

Interventions

DRUGEpcoritamab

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)

DRUGGemcitabine (1000 mg/m2)

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

DRUGOxaliplatin

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


Locations(1)

Hospital Universitario "Dr. José Eleuterio González"

Monterrey, Nuevo León, Mexico

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NCT07451652


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