Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma

• Status: Not yet recruiting
• Trial end date: 2025-06-01

Summary

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) on Day 9 or 10 of each cycle of combination therapy.

Patients will then undergo radiology imaging for disease assessment. Patients can proceed to autoSCT or epcoritamab monotherapy upon completion of Cycle 3 per investigator discretion. The rationale for subjects not proceeding to autoSCT will be captured in the eCRFs.

Hematopoietic stem cell mobilization and collection will be performed according to institutional standards. Patients who do not undergo autoSCT may remain on study treatment and continue epcoritamab monotherapy following completion of Cycle 3. Epcoritamab monotherapy may continue from Cycle 4 to Cycle 9, or until unacceptable toxicity, or disease progression per the Lugano Criteria.

• Phase: Phase 2

Details

• Lead Sponsor: Dipenkumar Modi
• Collaborator: Genmab