Condition: Large Cell Lymphoma, Diffuse · Relapsed Cancer · Refractory Cancer · Sponsor: Dipenkumar Modi
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 we…
This description comes directly from the study's public registry record.
Dipenkumar Modi, MD · 313-576-8739 · modid@karmanos.org
Allison Lipps · 317-634-5842 · alipps@hoosiercancer.org
Always discuss trial participation with your own doctor first.
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis, Indiana, United States | Recruiting |
| Karmanos Cancer Center (Wayne State University) | Detroit, Michigan, United States | Recruiting |
| University of Texas Southwestern Medical Center | Dallas, Texas, United States | Recruiting |
| University of Virginia Health System | Charlottesville, Virginia, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05852717