A Phase 2 interventional study of Epcoritamab and Gemcitabine (1000 mg/m2) in Relapsed/Refractory Diffuse Large B Cell Lymphoma, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Phase 2, Interventional, and Treatment
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.
1,868 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 355 are open to participants now.
This study's planned enrollment of 10 is below the median of 45 across 1,497 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Epcoritamab · Drug: Gemcitabine (1000 mg/m2) · Drug: Oxaliplatin
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 page: Gemcitabine
Subjects will receive gemcitabine 1000 mg/m2 on days 1 and 15 of the three 21-day cycles.
Subjects will receive oxaliplatin 100 mg/m2 on day 1 of three 21-day cycles.
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
Establish feasibility
Determine the number of subjects that complete the first cycle without need for hospitalization
Time frame: From enrollment up to day 29
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
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
Describe adverse events
Describe the number of subjects that develop any adverse events
Time frame: From day 1 up to week 10
Determine number of patients that follow through with transplant
Determine the number of patients that go through with stem cell transplant after finishing 3 cycles of Epcoritamab + GemOx
Time frame: From day one up through study completion, an average of 1 year
Duration of response
Determine the duration of response
Time frame: From week 18 through study completion, an average of 1 year
Progression free survival
Report the subjects´ progression free survival
Time frame: From week 18 up to six and twelve months
Overall survival
Report the overall survival
Time frame: From day 1 to twelve months
Plan to share: Undecided
Started Mar 2026 (actual). Primary completion is estimated for Sep 2027, 18 months after the start.
Of 210 non-industry phase 2 interventional studies under Lymphoma, Large B-Cell, Diffuse, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 96. This study's planned 18 months is below that.
Counting every sponsor, half of 264 studies reached it within 52 months; a quarter within 35 and three quarters within 85.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Epcoritamab · Gemcitabine · Oxaliplatin
Lymphoma, Large B-Cell, Diffuse →
Hospital Universitario Dr. Jose E. Gonzalez