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Recruiting NCT07451652

Low Dose Epcoritamab Plus GemOx in R/R DLBCL

Phase II Interventional Relapsed/Refractory Diffuse Large B Cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Epcoritamab, Gemcitabine (1000 mg/m2), Oxaliplatin.
Who it may be relevant to
Registry conditions: Relapsed/Refractory Diffuse Large B Cell Lymphoma. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Epcoritamab
    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)
  • Drug Gemcitabine (1000 mg/m2)
    Subjects will receive gemcitabine 1000 mg/m2 on days 1 and 15 of the three 21-day cycles.
  • Drug Oxaliplatin
    Subjects will receive oxaliplatin 100 mg/m2 on day 1 of three 21-day cycles.

Primary outcome measures

  • Determine ORR and CR after GemOx plus low-dose Epcoritamab [Time frame: From enrollment to the end of treatment at 14 weeks]
Secondary outcome measures (8)
  • Establish feasibility [Time frame: From enrollment up to day 29]
  • Describe cytokine release syndrome incidence [Time frame: From day 1 up to day 29]
  • Describe immune effector cell- associated neurotoxicity syndrome incidence [Time frame: From day 1 up to week 10]
  • Describe adverse events [Time frame: From day 1 up to week 10]
  • Determine number of patients that follow through with transplant [Time frame: From day one up through study completion, an average of 1 year]
  • Duration of response [Time frame: From week 18 through study completion, an average of 1 year]
  • Progression free survival [Time frame: From week 18 up to six and twelve months]
  • Overall survival [Time frame: From day 1 to twelve months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Mexico · 1 center
  • Hospital Universitario "Dr. José Eleuterio González" — Monterrey

Publications

  • Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, Lewis DJ, Sureda Balari A, Cunningham D, Oliveri RS, Elliott B, DeMarco D, Azaryan A, Chiu C, Li T, Chen KM, Ahmadi T, Lugtenburg PJ. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. doi: 10.1 PMID 34508654
  • Li T, Gibiansky L, Parikh A, Putnins M, Chiu CW, Sacchi M, Feng H, Ahmadi T, Gupta M, Xu S. Optimal Dosing Regimen for Epcoritamab, a Subcutaneous Bispecific Antibody, in Relapsed or Refractory Large B-Cell Lymphoma. Clin Pharmacol Ther. 2025 May;117(5):1437-1450. doi: 10.1002/cpt.3588. Epub 2025 Feb 11. PMID 39935086
  • Thieblemont C, Karimi YH, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Jurczak W, Do YR, Gasiorowski R, Lewis DJ, Kim TM, van der Poel M, Poon ML, Feldman T, Linton KM, Sureda A, Hutchings M, Dinh MH, Kilavuz N, Soong D, Mark T, Sacchi M, Phillips T, Lugtenburg PJ. Epcoritamab in relapsed/refractory large B-cell lymphoma: 2-year follow-up from the pivotal EPCORE NHL-1 trial. Leukemia. 2024 D PMID 39322711
  • Izutsu K, Kumode T, Yuda J, Nagai H, Mishima Y, Suehiro Y, Yamamoto K, Fujisaki T, Ishitsuka K, Ishizawa K, Ikezoe T, Nishikori M, Akahane D, Fujita J, Dinh M, Soong D, Noguchi H, Buchbjerg JK, Favaro E, Fukuhara N. Subcutaneous epcoritamab monotherapy in Japanese adults with relapsed/refractory diffuse large B-cell lymphoma. Cancer Sci. 2023 Dec;114(12):4643-4653. doi: 10.1111/cas.15996. Epub 202 PMID 37921363
  • Brody JD, Jorgensen J, Belada D, Costello R, Trneny M, Vitolo U, Lewis DJ, Karimi YH, Sureda A, Andre M, Wahlin BE, Lugtenburg PJ, Jiang T, Karagoz K, Steele AJ, Abbas A, Wang L, Risum M, Cordoba R. Epcoritamab plus GemOx in transplant-ineligible relapsed/refractory DLBCL: results from the EPCORE NHL-2 trial. Blood. 2025 Apr 10;145(15):1621-1631. doi: 10.1182/blood.2024026830. PMID 39792928

Identifiers

NCT: NCT07451652 · HE26-00003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗