Low-dose epcoritamab with GemOx for relapsed/refractory DLBCL
Low Dose Epcoritamab Plus Gemcitabine/Oxaliplatin in Treatment of Transplant Eligible Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
This trial will test whether adding a low dose of epcoritamab to GemOx chemotherapy helps people with relapsed or refractory diffuse large B‑cell lymphoma who are eligible for autologous stem cell transplant.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hospital Universitario Dr. Jose E. Gonzalez Academic / other |
| Drugs / interventions | Epcoritamab |
| Locations | 1 site (Monterrey, Nuevo León) |
| Trial ID | NCT07451652 on ClinicalTrials.gov |
What this trial studies
This is a phase 2, single-center interventional trial combining low-dose epcoritamab (12 mg) with GemOx chemotherapy (gemcitabine 1000 mg/m2 plus oxaliplatin) for patients with relapsed or refractory diffuse large B‑cell lymphoma who are candidates for autologous stem cell transplant. Participants receive the combination regimen and are monitored for tumor response, safety, and tolerability. The study enrolls adults with ECOG 0–2 who have had at least one prior line of therapy and meet Lugano criteria for active disease. Treatment and follow-up occur at Hospital Universitario "Dr. José Eleuterio González" in Monterrey, Mexico.
Who should consider this trial
Good fit: Ideal candidates are adults with relapsed or refractory diffuse large B‑cell lymphoma who have received at least one prior therapy, are eligible for autologous stem cell transplant, have ECOG 0–2, and no active infections or other active cancers.
Not a fit: Patients who have already received an autologous or allogeneic stem cell transplant, who have end‑stage organ failure, active infections, or other active malignancies are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, this regimen could increase response rates and help more patients reach autologous stem cell transplant.
How similar studies have performed: Other trials combining epcoritamab with chemotherapy backbones have shown promising activity in relapsed/refractory DLBCL, though the specific low 12 mg dose with GemOx is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Monterrey, Nuevo León
- Hospital Universitario "Dr. José Eleuterio González" — Monterrey, Nuevo León, Mexico (Recruiting)
Study contacts
- Principal investigator: Perla R Colunga-Pedraza, MD — Hospital Universitario "Dr. José Eleuterio González"
- Study coordinator: Perla R Colunga-Pedraza, MD
- Email: alrep_rcp@gmail.com
- Phone: +52 8110761973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.