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AzTrials

Diffuse Large B-Cell LymphomaPhase 2NCT05451810

A 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

A Phase 2 study testing Epcoritamab in people with Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma, run by Genmab at 72 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Classic Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Epcoritamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
72 sitesin 2 countries
Study dates
17 Aug 2022to Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Life expectancy >3 months on standard of care (SOC) treatment.
  • Meets the following disease activity criteria:
  • -- Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL):
  • Documented CD20+ mature B-cell neoplasm according to the the 5th edition of World Health Organization (WHO) classification of Haematolymphoid Tumours, based on most recent representative pathology report;
  • Diffuse large B-cell lymphoma, not otherwise specified (NOS) (de novo or transformed from follicular lymphoma (FL) or Marginal Zone Lymphoma [MZL]);
  • High-grade B-cell Lymphoma including "double-hit" or "triple-hit" DLBCL (technically classified in WHO 2022 or 2016 as high-grade B-cell lymphoma [HGBCL], with MYC and BCL2 and/or BCL6 translocations).
Show all 28Show fewer
  • Follicular large B-cell lymphoma (FLBL, formerly FL grade 3B);
  • Relapsed or refractory disease and previously treated with at least 1 prior systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody-containing therapy; Note: Relapsed disease is defined as disease that previously responded to therapy but progressed >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response to prior therapy, or progressed within 6 months after completion of therapy (including maintenance therapy).
  • Either failed prior autologous hematopoietic stem cell transplantation (HSCT), or ineligible for autologous HSCT including but not limited to age, Eastern Cooperative Oncology Group (ECOG) performance status, participant decision, comorbidities and/or insufficient response to prior treatment.
  • R/R Follicular Lymphoma:
  • Documented CD20+ mature B-cell neoplasm according to the 5th edition of WHO classification of Haematolymphoid Tumours, based on representative pathology report;
  • --- Classic FL (cFL) (previously FL grade 1, 2, or 3a) without clinical or pathological evidence of transformation;
  • Relapsed or refractory disease and previously treated with at least 2 prior lines of systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody containing therapy; Note: Relapsed disease is defined as disease that previously responded to therapy but progressed >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response to prior therapy, or progressed within 6 months after completion of therapy (including maintenance therapy).
  • Previously treated with an alkylating agent or lenalidomide;
  • Relapsed or refractory to the last prior line therapy. Previous lymphoma therapy is defined as 1 of the following: At least 2 months of single-agent therapy, at least 2 consecutive cycles of combination therapy, autologous HSCT, immunomodulatory therapy, or radioimmunotherapy.
  • Has at least one target lesion defined as:
  • >= 1 measurable nodal lesion (long axis > 1.5 cm) and/or >= 1 measurable extranodal lesion (long axis > 1.0 cm) on CT (or MRI) AND
  • FDG PET scan demonstrating positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites.
  • Must have ECOG performance status 0 - 2.
  • Must have acceptable organ (renal, liver, and hematologic) function within the screening period prior to the first dose of study drug:
  • Absolute neutrophil count (ANC) >= 1.0 × 10^9/L (growth factor support allowed in case of bone marrow involvement, but participant must have not received growth factor within 14 days prior to screening lab collection);
  • Hemoglobin >= 8.0 g/dL (RBC transfusions permitted, but participants must not have received blood transfusions within 7 days prior to Screening lab collection);
  • Platelet count >= 75 × 10^9/L, or >= 50 × 10^9/L in the presence of bone marrow involvement or splenomegaly (platelet transfusions are permitted, but participants must not have received blood transfusions within 7 days prior to Screening lab collection);
  • International normalized ratio (INR) (or Prothrombin Time [PT]) and aPTT <= 1.5 × upper limit of normal (ULN), unless receiving anticoagulation
  • Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) <= 3.0 × upper limit of normal (ULN); unless due to hepatic involvement of disease or non-hepatic origin. For participants with hepatic involvement of disease, serum AST and serum ALT <= 5.0 × ULN
  • Direct bilirubin <= 2 × ULN;
  • Estimated creatine clearance (CrCl) as calculated by Cockcroft-Gault Formula >= 45 mL/min, or estimated glomerular filtration rate (eGFR) as calculated by Modification of Diet in Renal Disease [MDRD] equation >= 45 mL/min;
  • Lymphocyte count < 5 × 10^9/L.

Who cannot join

  • Have a primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening as confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan (brain) and, if clinically indicated, by lumbar puncture.
  • Uncontrolled Human Immunodeficiency Virus (HIV) infection. HIV viral load that is undetectable and controlled with medication for at least 1 year prior to enrollment is allowed. Note: If participant has no history of HIV infection, HIV testing does not need to be conducted at screening unless it is required per local guidelines or institutional standards.

Trial locations and contacts

72 sites in 2 countries.

72 sites in 2 countries

United States70 sites

  • University of New Mexico /ID# 252434

    Albuquerque, New Mexico, 87102-4517

  • Lehigh Valley Hospital-Cedar Crest /ID# 244984

    Allentown, Pennsylvania, 18103-6202

  • Emory University, Winship Cancer Institute /ID# 246056

    Atlanta, Georgia, 30322

  • Texas Oncology - Austin Midtown /ID# 247656

    Austin, Texas, 78705

  • Our Lady Of The Lake Regional Medical Center /ID# 255008

    Baton Rouge, Louisiana, 70808

  • American Oncology Partners of Maryland /ID# 244968

    Bethesda, Maryland, 20817

  • Beverly Hills Cancer Center /ID# 255327

    Beverly Hills, California, 90211

  • Tufts Medical Center /ID# 246074

    Boston, Massachusetts, 02111-1552

  • Massachusetts General Hospital /ID# 245239

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center /ID# 248651

    Boston, Massachusetts, 02215-5400

  • Rocky Mountain Cancer Centers - Boulder /ID# 247653

    Boulder, Colorado, 80303

  • St. Luke's Hospital - Chesterfield /ID# 247815

    Chesterfield, Missouri, 63017

  • University of Illinois at Chicago /ID# 245038

    Chicago, Illinois, 60607

  • Oncology Hematology Care, Inc. /ID# 246182

    Cincinnati, Ohio, 45236-2725

  • Maryland Oncology Hematology /ID# 254192

    Columbia, Maryland, 21044-3128

  • OhioHealth Arthur G.H. Bing, MD Cancer Center /ID# 260803

    Columbus, Ohio, 43214-3908

  • Texas Oncology-Presbyterian Cancer Center Dallas /ID# 262659

    Dallas, Texas, 75231

  • Texas Oncology - Dallas - Worth Street /ID# 262956

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center /ID# 244552

    Dallas, Texas, 75390-7208

  • University of Iowa Health Care /ID# 258227

    Des Moines, Iowa, 50314-3017

  • Spoknwrd Clinical Trials /ID# 265232

    Easton, Pennsylvania, 18045

  • Willamette Valley Cancer Institute and Research Center /ID# 246410

    Eugene, Oregon, 97401-6043

  • Parkview Comprehensive Cancer Center /ID# 244545

    Fort Wayne, Indiana, 46845

  • Compassionate Cancer Care Research Group - Fountain Valley /ID# 246133

    Fountain Valley, California, 92708-7501

  • UCSF Fresno /ID# 263286

    Fresno, California, 93701-2302

  • Virginia Cancer Specialists - Gainesville /ID# 248760

    Gainesville, Virginia, 20155-3257

  • Cancer & Hematology Centers of Western Michigan - East /ID# 244985

    Grand Rapids, Michigan, 49546-7062

  • East Carolina University - Brody School of Medicine /ID# 248989

    Greenville, North Carolina, 27834

  • Prisma Health /ID# 247654

    Greenville, South Carolina, 29605

  • The John Theurer Cancer /ID# 262532

    Hackensack, New Jersey, 07601

  • Hattiesburg Clinic /ID# 244980

    Hattiesburg, Mississippi, 39401

  • Penn State Milton S. Hershey Medical Center /ID# 244979

    Hershey, Pennsylvania, 17033-2360

  • Indiana Blood & Marrow Transpl /ID# 244971

    Indianapolis, Indiana, 46237

  • Cancer Specialists of North Florida /ID# 261842

    Jacksonville, Florida, 32256

  • Florida Cancer Specialists /ID# 260854

    Lake Mary, Florida, 32746-2115

  • Dartmouth-Hitchcock Medical Center - 1 Medical Center Drive /ID# 245003

    Lebanon, New Hampshire, 03756

  • NHO - Nebraska Hematology-Oncology /ID# 263164

    Lincoln, Nebraska, 68506

  • University of Arkansas for Medical Sciences /ID# 244562

    Little Rock, Arkansas, 72205

  • University of California, Los Angeles /ID# 244573

    Los Angeles, California, 90095

  • The West Clinic /ID# 245004

    Memphis, Tennessee, 38120

  • Mount Sinai Medical Center-Miami Beach /ID# 249045

    Miami Beach, Florida, 33140-2948

  • Infirmary Health - Infirmary Cancer Care at Mobile Infirmary /ID# 264630

    Mobile, Alabama, 36607

  • Morristown Medical Center /ID# 244973

    Morristown, New Jersey, 07960-6136

  • Vanderbilt University Medical Center /ID# 260953

    Nashville, Tennessee, 37232

  • New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 264681

    New Hyde Park, New York, 11042

  • Stony Brook University Medical Center /ID# 244631

    New York, New York, 10021

  • New York Cancer and Blood Specialists - New York /ID# 264676

    New York, New York, 10028

  • Icahn School of Medicine at Mount Sinai /ID# 258610

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center-Koch Center /ID# 244628

    New York, New York, 10065-6007

  • Illinois Cancer Specialists /ID# 247655

    Niles, Illinois, 60714

  • Virginia Oncology Associates - Norfolk (Lake Wright) /ID# 265514

    Norfolk, Virginia, 23502

  • University of Oklahoma, Stephenson Cancer Center /ID# 244568

    Oklahoma City, Oklahoma, 73104-5418

  • Memorial Hospital West /ID# 248432

    Pembroke Pines, Florida, 33028

  • UPMC Hillman Cancer Ctr /ID# 244571

    Pittsburgh, Pennsylvania, 15232

  • New York Cancer and Blood Specialists /ID# 259016

    Port Jefferson Station, New York, 11776-8060

  • Blue Ridge Cancer Center /ID# 260597

    Roanoke, Virginia, 24014-2419

  • Oregon Oncology Specialists in Salem /ID# 260570

    Salem, Oregon, 97301-3975

  • Texas Oncology - San Antonio Medical Center /ID# 247658

    San Antonio, Texas, 78240-5251

  • Highlands Oncology Group, PA /ID# 245002

    Springdale, Arkansas, 72762

  • Bennett Cancer Center - Stamford Hospital /ID# 244530

    Stamford, Connecticut, 06902-3602

  • Northwest Medical Specialties - Tacoma /ID# 245045

    Tacoma, Washington, 98405

  • BRCR Medical Center Inc /ID# 262527

    Tamarac, Florida, 33321-2919

  • New York Cancer and Blood Specialists - Bronx /ID# 264690

    The Bronx, New York, 10469

  • Toledo Clinic Cancer Center - Main /ID# 246852

    Toledo, Ohio, 43623

  • Texas Oncology - Northeast Texas /ID# 247657

    Tyler, Texas, 75702

  • MedStar Washington Hospital Center /ID# 246068

    Washington D.C., District of Columbia, 20010

  • Reading Hospital; McGlinn Cancer Institute /ID# 259181

    West Reading, Pennsylvania, 19611-2143

  • Cleveland Clinic Florida /ID# 244532

    Weston, Florida, 33331-3609

  • Wake Forest Univ HS /ID# 245005

    Winston-Salem, North Carolina, 27157

  • Trinity Health St. Joseph Mercy Ann Arbor /ID# 244547

    Ypsilanti, Michigan, 48197-1051

Other trials in United States

Puerto Rico2 sites

  • Pan American Center for Oncology Trials, LLC /ID# 254952

    Rio Piedras, Puerto Rico, 00935

  • Auxilio Mutuo Cancer Center /ID# 254953

    San Juan, Puerto Rico, 00918

Other trials in Puerto Rico

About this study

Official title: A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) When Administered in the Outpatient Setting

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Classic Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) who have received at least 1 prior line of systemic antilymphoma therapy including at least 1 anti-CD20 monoclonal antibody-containing therapy or R/R classic follicular lymphoma (cFL). Adverse events will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R cFL. Study doctors will assess participants in a monotherapy treatment arm of epcoritamab. Participants will receive escalating doses of epcoritamab, until full dose is achieved. Approximately 184 adult participants with R/R DLBCL and R/R cFL will be enrolled in the study in approximately 80 sites in the United States of America.

Read more

Participants will receive escalating doses of subcutaneous epcoritamab, until full dose is achieved, in 28-day cycles.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Being tested
Epcoritamab
Keywords
Relapsed or Refractory Diffuse Large B-Cell Lymphoma, Relapsed or Refractory Classic Follicular Lymphoma, Non-Hodgkins Lymphoma, Cancer, Epcoritamab, ABBV-GMAB-3013, EPCORE
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Recurrence, Lymphoma, Non-Hodgkin, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EpcoritamabDrug

    Also called ABBV-GMAB-3013

    Subcutaneous Injection (SC)

Study groups in NCT05451810
Study groupRoleWhat they receive
Main Cohort: Epcoritamab Diffuse Large B-Cell Lymphoma (DLBCL)ExperimentalParticipants with relapsed or refractory (R/R) DLBCL will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Receives: Drug: Epcoritamab
Main Cohort: Epcoritamab Classic Follicular Lymphoma (cFL)ExperimentalParticipants with R/R cFL will receive SC epcoritamab in 28 day cycles.
Receives: Drug: Epcoritamab
Diversity Enriched Cohort: Epcoritamab DLBCLExperimentalParticipants with R/R DLBCL will receive SC epcoritamab in 28 day cycles.
Receives: Drug: Epcoritamab
Diversity Enriched Cohort: Epcoritamab cFLExperimentalParticipants with R/R cFL will receive SC epcoritamab in 28 day cycles.
Receives: Drug: Epcoritamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Experiencing Grade 3 or Higher Cytokine Release Syndrome (CRS) Events

    Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.

    Measured: Up to 3 Months

  2. Percentage of Participants Experiencing Grade 3 or Higher Immune Cell-Associated Neurotoxicity Syndrome (ICANS) Events

    ICANS events will be graded using ASTCT, with a higher grade indicating higher severity.

    Measured: Up to 3 Months

  3. Percentage of Participants Experiencing Grade 3 or Higher Neurotoxicity (Ntox) Events

    Ntox is defined as the percentage of participants who developed at least 1 Grade 3 or higher Ntox since the initiation of epcoritamab treatment.

    Measured: Up to 3 Months

Secondary outcomes (22)

  1. Best Overall Response (BOR) Determined by Lugano 2014 Criteria Per Investigator Assessment

    BOR is defined as the percentage of participants who achieved best overall response of complete response (CR) or partial response (PR) determined by Lugano 2014 criteria as assessed by investigators.

    Measured: Up to 3 Months

  2. CR Determined by Lugano 2014 Criteria Per Investigator Assessment

    Complete response is defined as the percentage of participants who achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.

    Measured: Up to 3 Months

  3. Diversity Enriched Cohort: Incidence of Treatment-Emergent Adverse Events (TEAEs) by Severity Level

    Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.

    Measured: Up to 3 Months

  4. Diversity Enriched Cohort: Severity of TEAEs by Severity Level

    Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.

    Measured: Up to 3 Months

  5. Diversity Enriched Cohort: Incidence of Serious Adverse Events (SAEs) by Severity Level

    A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

    Measured: Up to 3 Months

  6. Diversity Enriched Cohort: Severity of SAEs by Severity Level

    A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

    Measured: Up to 3 Months

  7. Diversity Enriched Cohort: Median Time to Onset of CRS of Grade 3 or Higher

    Median time to onset of CRS of Grade 3 or higher.

    Measured: Up to 3 Months

  8. Diversity Enriched Cohort: Median Time to Resolution of CRS of Grade 3 or Higher

    Median time to resolution of CRS of Grade 3 or higher.

    Measured: Up to 3 Months

  9. Diversity Enriched Cohort: Median Time to Onset of ICANS of Grade 3 or Higher

    Median time to onset of ICANS of Grade 3 or higher.

    Measured: Up to 3 Months

  10. Diversity Enriched Cohort: Median Time to Resolution of ICANS of Grade 3 or Higher

    Median time to resolution of ICANS of Grade 3 or higher.

    Measured: Up to 3 Months

  11. Diversity Enriched Cohort: Median Time to Onset of Ntox of Grade 3 or Higher

    Median time to onset of Ntox of Grade 3 or higher.

    Measured: Up to 3 Months

  12. Diversity Enriched Cohort: Median Time to Resolution of Ntox of Grade 3 or Higher

    Median time to resolution of Ntox of Grade 3 or higher.

    Measured: Up to 3 Months

  13. Diversity Enriched Cohort: Percentage of Participants Experiencing Any Adverse Events (AE)s

    An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

    Measured: Up to 3 Months

  14. Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of CRS After the First Full Dose of Epcoritamab

    Percentage of participants receiving various interventions for the management of CRS after the first full dose of epcoritamab.

    Measured: Up to 3 Months

  15. Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of ICANS After the First Full Dose of Epcoritamab

    Percentage of participants receiving various interventions for the management of ICANS after the first full dose of epcoritamab.

    Measured: Up to 3 Months

  16. Diversity Enriched Cohort: Percentage of Participants Receiving Various Interventions for the Management of Ntox After the First Full Dose of Epcoritamab

    Percentage of participants receiving various interventions for the management of Ntox after the first full dose of epcoritamab.

    Measured: Up to 3 Months

  17. Diversity Enriched Cohort: Duration of response (DOR)

    Duration of response is defined for participants who achieved BOR of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

    Measured: Up to 3 Months

  18. Diversity Enriched Cohort: Progression-free survival (PFS)

    Progression-free survival is defined as the time in months from the first dose of study drug to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.

    Measured: Up to 3 Months

  19. Diversity Enriched Cohort: Overall survival (OS)

    Overall survival is defined for as the time in months from first dose of epcoritamab to death from any cause.

    Measured: Up to 3 Months

  20. Diversity Enriched Cohort: Time-to-response (TTR)

    Time to response is defined for participants who achieved BOR of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by investigator, as the time in months from first dose of study drug to initial CR/PR.

    Measured: Up to 3 Months

  21. Diversity Enriched Cohort: Duration of CR (DOCR)

    The duration of complete response is defined for participants who achieved BOR of CR (Complete Responders), as the duration from the first CR response to the earliest date of disease progression determined per Lugano 2014 criteria, as assessed by the investigator, or death, whichever occurs first.

    Measured: Up to 3 Months

  22. Diversity Enriched Cohort: Time to Next Treatment

    Time to next treatment is defined as the time from the date of the first dose of study drug to the start of new non-protocol-specified treatment or death from any cause.

    Measured: Up to 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start17 Aug 2022
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
184 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05451810
Sponsor's protocol ID
M23-362
Status last verified
Sep 2026
First submitted
6 Jul 2022
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Epcoritamab in people with Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma, run by Genmab at 72 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Experiencing Grade 3 or Higher Cytokine Release Syndrome (CRS) Events (time frame: Up to 3 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05451810.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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