Low Dose Epcoritamab Plus GemOx in R/R DLBCL

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Study ID
NCT07451652
Phase
PHASE2
Status
Recruiting
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Conditions

  • Relapsed/Refractory Diffuse Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Mar 17, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Epcoritamab + GemOx
    Subjects will receive Gemcitabine/Oxaliplatin at usual doses as well as Epcoritamab with 2 step up doses followed by 12 mg weekly for 3 cycles.

Primary Outcome Measure

Determine ORR and CR after GemOx plus low-dose Epcoritamab [ Time Frame: From enrollment to the end of treatment at 14 weeks ]

Central Contacts