Actively Recruiting
A Phase 2 Study of Epcoritamab-R-GemOx With Consolidative ASCT and Additional Epcoritamab in Relapsed/Refractory Transplant-Eligible Diffuse Large B-Cell Lymphoma
Led by City of Hope Medical Center ยท Updated on 2026-04-24
43
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a treatment approach for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are eligible for stem cell transplant but whose cancer has not responded well to prior therapies. The trial evaluates epcoritamab combined with rituximab, gemcitabine, and oxaliplatin (R-GemOx) given as salvage therapy before autologous stem cell transplant (ASCT). Epcoritamab is a bispecific antibody designed to bring immune T cells and lymphoma cells together to help the immune system target the cancer. Participants receive epcoritamab by subcutaneous injection on specific days during each 14-day cycle along with R-GemOx chemotherapy on day 1 for up to three cycles, with the option for one additional cycle depending on response. After salvage therapy, eligible patients undergo ASCT. Those who respond but cannot have ASCT may receive consolidation therapy with epcoritamab over several 28-day cycles to further treat the lymphoma. Throughout the study, participants will have blood samples taken and imaging scans including PET/CT to monitor response. Bone marrow biopsies and tissue biopsies may also be performed as needed. After treatment, follow-up visits occur at 30 and 60 days, then at 12 and 24 months to assess treatment outcomes such as complete response and survival, as well as monitor side effects and overall health.
CONDITIONS
Brief Title
Epcoritamab, Rituximab, Gemcitabine and Oxaliplatin (R-GemOx) as Salvage Therapy Before Autologous Stem Cell Transplant for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent and assent when appropriate
- Agreed to allow use of archival tumor tissue or received PI approval for exceptions
- At least 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Histologically confirmed diagnosis of DLBCL, transformation of indolent B-cell lymphoma, High grade B-cell lymphoma (HGBCL), or primary mediastinal large B-cell lymphoma
- Biopsy-proven relapsed or refractory disease after at least one prior chemoimmunotherapy
- Eligible for high-dose chemotherapy and autologous stem cell transplant
- Fully recovered from prior anti-cancer therapy toxicities except alopecia
- Positive for CD20 by immunohistochemistry
- Adequate blood counts and organ function within specified limits
- Seronegative or controlled HIV, hepatitis B or C infection
- Women of childbearing potential with negative pregnancy test and agreement to use effective contraception
- Male participants agreeing to use contraception or abstinence during and after treatment
- Meet institutional infectious disease testing requirements
- ECOG of 2 or less before consolidation therapy
- No active grade 3 or higher infection before consolidation therapy
- No active malignancy requiring therapy except certain treated skin or cervical cancers
- No symptomatic cardiac or central nervous system lymphoma involvement
- No history of progressive multifocal leukoencephalopathy (PML)
- Able to tolerate subcutaneous injections
- Able to comply with study procedures
You will not qualify if you...
- Autologous or allogeneic stem cell transplant within 1 year before study therapy
- Chemotherapy, biological therapy, or immunotherapy within 21 days prior to study except single R-GemOx cycle
- Recent radiotherapy or major surgery within 4 weeks before study therapy
- Prior solid organ transplant
- Live vaccination within 4 weeks before or during study participation
- Use of medications that decrease T-cell activity except low-dose prednisone
- Active central nervous system lymphoma involvement
- Significant uncontrolled cardiovascular disease or recent heart events
- Clinically significant liver disease or alcohol abuse
- Severe allergic reactions to study drugs or components
- Active uncontrolled infections or recent infections needing antibiotics
- Current seizure disorder requiring treatment
- Peripheral neuropathy grade above 1 except related to lymphoma
- Other active malignancies interfering with study safety or efficacy
- Toxicities from prior therapy not resolved to grade 0 or 1 except alopecia
- Pregnant or breastfeeding females
- Unable to tolerate subcutaneous injections
- Any other condition contraindicating study participation in investigator's judgment
- Inability to comply with study procedures due to feasibility or logistics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessments
Duration - Up to approximately 6 weeks
Participants receive epcoritamab subcutaneously and R-GemOx chemotherapy every 14 days for up to 3 cycles to treat lymphoma. One additional cycle may be given if response is observed and deemed necessary.
Up to 4 visits every 14 days for treatment administration
Duration - Variable based on transplant procedure and recovery
Participants who respond to salvage therapy undergo autologous stem cell transplant as part of their treatment.
1 procedure with additional hospital visits for recovery as needed
Duration - Up to approximately 6 months
Participants receive additional epcoritamab subcutaneous injections in cycles every 28 days for up to 6 cycles to consolidate treatment response if unable to proceed to ASCT or after ASCT.
Multiple visits for epcoritamab injections on days 1, 8, and 15 of cycle 1, then days 1 and 15 of subsequent cycles
Duration - Up to 2 years
Participants are monitored for safety and treatment outcomes after completion of study treatment.
Visits at 30 and 60 days post-treatment, then at 12 and 24 months
Trial Site Locations
Total: 3 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope Atlanta Cancer Center
Newnan, Georgia, United States, 30265
Not Yet Recruiting
3
City of Hope at Chicago
Zion, Illinois, United States, 60099
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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