Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Subjects with relapsed large cell lymphoma will receive 3 cycles of combination therapy consisting of GDP and epcoritamab. Each cycle will last 21 days. GDP consists of gemcitabine 1000 mg/m2 IV on Days 1 and 8, cisplatin 75 mg/m2 IV on Day 1, and dexamethasone 40 mg orally on Days 1 through 4. Epcoritamab will be administered subcutaneously (SC) on Days 1, 8, and 15. Patients will receive granulocyte colony stimulating factor (G-CSF) between Day 8 through Day 10 of each cycle of combination therapy. Patients will then undergo radiology imaging for disease assessment. Patients may proceed to SCT(autologous or allogeneic) or CAR T-cell therapy or epcoritamab monotherapy upon completion of Cycle 3 per investigator discretion. The rationale for subjects not proceeding to autoSCT or CAR T-cell therapy will be captured in the eCRFs. Patients who do not undergo SCT or CAR T-cell therapy may have the option to receive study treatment with epcoritamab monotherapy following completion of Cycle 3. Epcoritamab monotherapy will be offered to selected subjects who become ineligible to undergo SCT or CAR T-cell therapy (such as social situation, change in subject decision). The decision to offer epcoritamab monotherapy will be per investigator's discretion. However, subjects must have demonstrated a response to the combination therapy (partial remission or complete remission) per disease assessment scans prior to offering epcoritamab monotherapy. Epcoritamab monotherapy should begin 2 weeks following Cycle 3 Day 15. Monotherapy will consist of epcoritamab 48 mg administered subcutaneously on Days 1 and 15 of each 28 day cycle for Cycle 4 to Cycle 9 or until unacceptable toxicity, or disease progression per the Lugano Criteria.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony histologicznie nawrotowy chłoniak z dużych komórek B-komórkowych (CD20+)
- •Widoczne guzy w badaniu PET o wielkości powyżej 1,5 cm (węzły) lub powyżej 1 cm (guzy poza węzłami)
- •Wcześniejsze leczenie chemioterapią (co najmniej jeden schemat)
- •Zdolność do przeszczepienia komórek macierzystych lub terapii CAR T (według opinii lekarza)
- •Ogólny stan zdrowia pozwalający na udział w badaniu (ECOG 0-2)
✗ Disqualifies
- •Chłoniak Burkitta
- •Chłoniak limfoplazmatyczny
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 10, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (4)
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, United States
Karmanos Cancer Center (Wayne State University)
Detroit, United States
University of Texas Southwestern Medical Center
Dallas, United States
University of Virginia Health System
Charlottesville, United States
Trial contact
Dipenkumar Modi, MD
Allison Lipps
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/11/2026.
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