A Phase 2 interventional study of Autologous Hematopoietic Stem Cell Transplantation and Biopsy Procedure in Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified and Recurrent Primary Mediastinal Large B-Cell Lymphoma, sponsored by City of Hope Medical Center. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by City of Hope Medical Center · Phase 2, Interventional, and Treatment
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Among 24 studies testing epcoritamab in Lymphoma, Large B-Cell, Diffuse — 16 open to participants now, 23 under way, 3 of them phase 3. epcoritamab · Lymphoma, Large B-Cell, Diffuse.
Among the 24 studies testing epcoritamab in Lymphoma, Large B-Cell, Diffuse, this one is the 12th largest by planned enrollment, is one of 7 that started in 2026, is one of 14 in phase 2, reaches primary completion later than 15 of the 22 other live ones, and was the 19th registered.
1,870 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 357 are open to participants now.
Browse Lymphoma, Large B-Cell, Diffuse studies →16 of the 24 studies testing epcoritamab in Lymphoma, Large B-Cell, Diffuse are open now, in 5 countries. Recruiting first, the newest first:
University of Utah · Sites in United States
Ages 18+
Hospital Universitario Dr. Jose E. Gonzalez · Sites in Mexico
Ages 18–65
University of Miami · Sites in United States
Ages 18+
University of Washington · Sites in United States
Ages 18+
Universität Münster · Sites in Germany
Ages 18+
By country, each count listing its studies:
epcoritamab: first FDA approval 2023 (EPKINLY), first EMA approval 2023. What it is approved for, and how studies give it, is on its page →
Of the 266 Lymphoma, Large B-Cell, Diffuse studies recruiting now, 177 (67%) set no upper age limit and 51 (19%) stop at 75 or younger; 25 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 17 · Phase 3 3
First in 2020; this study’s year is marked. 7 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 43 is close to the median of 45 across 1,499 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Median enrollment 41 across the 24 interventional studies. Of the 1 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
8 of 24 have an industry lead sponsor. The 10 most frequent:
City of Hope Medical Center is the lead sponsor of 677 studies on the registry; 181 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 12 (39%) have results posted.
39 studies in Lymphoma, Large B-Cell, Diffuse by City of Hope Medical Center: 7 open now, 15 under way, none of them phase 3. Of 23 finished, 11 (48%) have results posted.
Among the 39 studies in Lymphoma, Large B-Cell, Diffuse by City of Hope Medical Center, this one is the 10th largest by planned enrollment of the 36 interventional ones that give a count, is one of 2 that started in 2026, is one of 11 in phase 2, reaches primary completion later than 14 of the 14 other live ones, and was the 39th registered.
City of Hope Medical Center’s Lymphoma, Large B-Cell, Diffuse studies by the year they started, since 1998.
8 of the studies testing epcoritamab in Lymphoma, Large B-Cell, Diffuse that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06672705Timothy VoorheesEpcoritamab for the Treatment of Relapsed or Refractory Post Transplant Lymphoproliferative Disorders | 2026-12-31 |
| NCT05451810GenmabA Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma | 2027-03 |
| NCT06536049Yazeed SawalhaEpcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma | 2027-08-31 |
| NCT04542824GenmabTrial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL) | 2027-09 |
| NCT07451652Hospital Universitario Dr. Jose E. GonzalezLow Dose Epcoritamab Plus GemOx in R/R DLBCL | 2027-09 |
Add all 8 to your calendar (.ics) → With an account.
Among the 24 studies testing epcoritamab in Lymphoma, Large B-Cell, Diffuse, from their registry updates:
Among City of Hope Medical Center’s 39 in Lymphoma, Large B-Cell, Diffuse:
This tab as a report to print or save as PDF → With an account.
This phase II trial tests how well epcoritamab in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) works as treatment given after the cancer has not responded to other treatments (salvage therapy) before autologous stem cell transplant in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Epcoritamab is a so-called bispecific antibody, a molecule that can bind simultaneously to two different receptors (proteins present on the cell surface). Epcoritamab binds to a receptor called CD3 with one part of the antibody and to a receptor called CD20 with another part of the antibody. CD3 is expressed on T cells, which are important cells of the immune system that help the body fight cancers and infections. CD20 is expressed on the surface of DLBCL cells. By simultaneous binding to CD3 and CD20, epcoritamab brings T cells and DLBCL cells close together and activates the T cells to kill the lymphoma cells. Rituximab is a so-called monoclonal antibody, a molecule that binds to a single receptor. Like epcoritamab, rituximab binds to CD20. After binding to CD20, rituximab activates the immune system to kill the lymphoma cell through several different mechanisms. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Giving epcoritamab-R-GemOx as therapy before an autologous stem cell transplant may help kill cancer cells in the body and help make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.
PRIMARY OBJECTIVE:
I. Estimate the proportion of relapsed/refractory (r/r) transplant-eligible DLBCL patients who achieve complete response (CR) following epcoritamab + R-GemOx.
SECONDARY OBJECTIVES:
I. Estimate the overall response rate (ORR) of r/r transplant-eligible DLBCL patients following epcoritamab + R-GemOx.
II. Estimate the proportion of r/r transplant-eligible DLBCL patients who successfully undergo autologous stem cell transplant (ASCT) following epcoritamab + R-GemOx, including rate of stem cell mobilization failure.
III. Estimate progression-free survival (PFS), duration of response (DOR), and overall survival (OS) for r/r transplant-eligible DLBCL patients following epcoritamab + R-GemOx (with/without subsequent ASCT and epcoritamab consolidation).
IV. Evaluate the toxicity of epcoritamab + R-GemOx and the toxicity of epcoritamab consolidation in r/r DLBCL.
EXPLORATORY OBJECTIVES:
I. Assess CR rate, ORR, PFS, DOR, and OS separately for r/r DLBCL patients receiving epcoritamab + R-GemOx with and without prior chimeric antigen receptor (CAR) T.
II. Assess DOR/PFS/OS for patients with CR/PR after epcoritamab + R-GemOx but do not proceed to ASCT.
III. Assess kinetics of circulating tumor deoxyribonucleic acid (ctDNA) in r/r DLBCL patients receiving epcoritamab + R-GemOx and the impact of minimal residual disease (MRD) on patient outcomes.
OUTLINE:
SALVAGE THERAPY: Patients receive epcoritamab subcutaneously (SC) on day 8 of cycle 1 and days 1 and 8 of subsequent cycles and R-GemOx on day 1 of each cycle. Cycles repeat every 14 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or partial response (PR) after cycle 3 may receive one additional cycle at the treating physician's discretion. Patients with CR or PR after completion of Salvage Therapy who are unable to proceed to ASCT may receive Consolidation Therapy as below.
ASCT: Patients undergo ASCT.
CONSOLIDATION: Patients receive epcoritamab SC on days 1, 8, and 15 of cycle 1 and on days 1 and 15 of subsequent cycles. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Patients also undergo blood sample collection and positron emission tomography and computed tomography (PET/CT) throughout the study. Patients also undergo bone marrow biopsy and/or aspiration as clinically indicated and may undergo tissue biopsy on study.
After completion of study treatment, patients are followed up at 30 and 60 days, and then at 12 and 24 months.
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.
Documented of the participant and/or legally authorized representative.
Agreement to allow the use of from diagnostic tumor biopsies
Biopsy-proven disease after 1 prior line of chemoimmunotherapy and:
CAR-naïve patients (Cohort 1)
CAR-experienced patients (Cohort 2)
Without bone marrow involvement: (ANC) ≥ 1,000/mm\^3
Without bone marrow involvement: ≥ 100,000/mm\^3. With bone marrow involvement: Platelets ≥ 75,000/mm\^3
≥ 8g/dL
Total ≤ 1.5 X (ULN)
Seronegative for antigen/antibody (Ag/Ab) combo, virus (HCV), active virus (HBV) (surface antigen negative) OR
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Meets other institutional and federal requirements for infectious disease titer requirements
Agreement by females and males of childbearing potential* to use an effective method of or abstain from heterosexual intercourse for the course of the study and after completion of study treatment as described below separately for males and females.
Female participants must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for at least 6 months after the last dose of gemcitabine, 9 months after the last dose of oxaliplatin, and 12 months after the last dose of rituximab, 12 months after the final dose of epcoritamab and 3 months after the final dose of tocilizumab (as applicable), whichever is longer. Women must refrain from donating eggs during this same period.
For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agree to refrain from donating sperm, as defined below:
Exclusion Criteria:
Vaccination with within 4 weeks of the first dose of study drug or is expected to need any live vaccination during study participation including at least 3 months following the last dose of study treatment.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
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.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SALVAGE THERAPY: Patients receive epcoritamab SC on day 8 of cycle 1 and days 1 and 8 of subsequent cycles and R-GemOx on day 1 of each cycle. Cycles repeat every 14 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients with CR or PR after cycle 3 may receive one additional cycle at the treating physician's discretion. Patients with CR or PR after completion of Salvage Therapy who are unable to proceed to ASCT may receive Consolidation Therapy as below. ASCT: Patients undergo ASCT. CONSOLIDATION: Patients receive epcoritamab SC on days 1, 8, and 15 of cycle 1 and on days 1 and 15 of subsequent cycles. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and PET/CT throughout the study. Patients also undergo bone marrow biopsy and/or aspiration as clinically indicated and may undergo tissue biopsy on study.
Procedure: Autologous Hematopoietic Stem Cell Transplantation · Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Procedure: Bone Marrow Aspiration · Procedure: Bone Marrow Biopsy · Procedure: Computed Tomography · Biological: Epcoritamab · Drug: Gemcitabine · Drug: Oxaliplatin · Procedure: Positron Emission Tomography · Biological: Rituximab
Undergo ASCT
Also known as: AHSCT, Autologous, Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell Transplant, Autologous Stem Cell Transplantation, Stem Cell Transplantation, Autologous
Undergo tissue biopsy
Also known as: Biopsy, BIOPSY_TYPE, Bx
Undergo blood sample collection
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo bone marrow aspiration
Undergo bone marrow biopsy
Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow
Undergo CT
Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography
Given SC
Also known as: Anti-CD20/CD3 Bispecific Antibody GEN3013, DuoBody-CD3xCD20, Epcoritamab-bysp, Epkinly, GEN 3013, GEN-3013, GEN3013, Tepkinly
Given gemcitabine
Also known as: dFdC, dFdCyd, Difluorodeoxycytidine
Given oxaliplatin
Also known as: 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, Elplat, JM 83, JM-83, JM83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, RP54780, SR 96669, SR-96669, SR96669
Undergo PET
Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
Given rituximab
Also known as: ABP 798, ABP-798, ABP798, BI 695500, BI-695500, BI695500, Blitzima, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT P10, CT-P10, CTP10, GP 2013, GP-2013, GP2013, IDEC 102, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, IDEC102, Ikgdar, Mabtas, MabThera, Monoclonal Antibody IDEC-C2B8, PF 05280586, PF-05280586, PF05280586, Riabni, Ritemvia, Rituxan, Rituximab ABBS, Rituximab ARRX, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar GP2013, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, Rituximab Biosimilar SIBP-02, rituximab biosimilar TQB2303, Rituximab PVVR, Rituximab-abbs, Rituximab-arrx, Rituximab-blit, Rituximab-pvvr, Rituximab-rite, Rituximab-rixa, Rituximab-rixi, Rixathon, Riximyo, RTXM 83, RTXM-83, RTXM83, Ruxience, Truxima
Complete response (CR)
Defined as achieving a best response of CR during/after epcoritamab + rituximab, gemcitabine and oxaliplatin (R-GemOx) salvage therapy (prior to autologous stem cell transplantation \[ASCT\] or any non-protocol anti-lymphoma therapy) in a response-evaluable participant. Will be estimated by the binomial proportion along with the 95% exact binomial confidence interval
Time frame: Up to 2 years
Overall response
Defined as achieving a best response of CR or partial response (PR) during/after epcoritamab + R-GemOx salvage therapy (prior to ASCT or any non-protocol anti-lymphoma therapy) in a response-evaluable participant. Will be estimated by the binomial proportion along with the 95% exact binomial confidence interval.
Time frame: Up to 2 years
Ability to proceed to ASCT
Defined as being able to proceed to and also receive an ASCT after epcoritamab + R-GemOx salvage therapy. Will be estimated by the binomial proportion along with the 95% exact binomial confidence interval.
Time frame: Up to 2 years
Progression-free survival
Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.
Time frame: From start of protocol treatment to time of disease relapse/progression or death due to any cause, whichever occurs earlier, assessed up to 2 years
Duration of response
Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.
Time frame: From the time of first achieving CR/PR during/after epcoritamab + R-GemOx salvage therapy to time of disease relapse/progression or death due to any cause, whichever occurs earlier, assessed up to 2 yrs
Overall survival
Will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation.
Time frame: Time in a participant from start of protocol treatment to time of death due to any cause, assessed up to 2 years
Stem cell mobilization failure
Defined as failure to collect adequate CD34 stem cells (within 3 attempts) in a participant who attempt stem cell collection. Will be estimated by the binomial proportion along with the 95% exact binomial confidence interval.
Time frame: Up to 2 years
Incidence of adverse events
Toxicities will be coded and collected per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, except that cytokine-release syndrome and Immune effector cell-associated neurological toxicity syndrome will be coded and collected per American Society for Transplantation and Cellular Therapy criteria.
Time frame: Up to 2 years
Started Jul 2026 (actual). Primary completion is estimated for Oct 2029, 38 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 38 months is below that.
Counting every sponsor, half of 264 studies reached it within 53 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 · Rituximab
Lymphoma, Large B-Cell, Diffuse →