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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Dipenkumar Modi
Study ID
NCT05852717
Phase
PHASE2
Status
Recruiting
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Conditions

  • Large Cell Lymphoma, Diffuse
  • Refractory Cancer
  • Relapsed Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AutoSCT OR CAR T-cell Therapy — PROCEDURE
    Autologous stem cell transplant (AutoSCT) or CAR T-cell therapy will be performed after Cycle 3 of receiving epcoritamab and GDP
  • GDP — DRUG
    Gemcitabine Cisplatin Dexamethasone
  • Epcoritamab — DRUG
    Epcoritamab

Study Details

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.

Key Dates

Start date
Oct 31, 2023
Status verified
May 2026
Primary completion
Nov 24, 2027
Completion
Nov 24, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GDP + Epcoritamab + AutoSCT or CAR T-cell therapy
    Cycles 1-3 (Cycle = 21 days) Epcoritamab will be administered by subcutaneous injection Days 1, 8, and 15. Epcoritamab Day 1: 0.16mg, Day 8: 0.8mg, Day 15: 48mg except Cycle 2-Epcoritamab will administered at 48mg on Days 1, 8 and 15 Gemcitabine will be administered by IV infusion on Days 1 and 8. Gemcitabine Days 1,8: 1,000mg/m\^2 Cisplatin will be administered by IV infusion on Day 1. Cisplatin Day 1: 75mg/m\^2 Dexamethasone will be given by mouth on Days 1-4. Dexamethasone Days 1-4: 40mg After completion of Cycle 3 Autologous stem cell transplant (AutoSCT) OR CAR T-cell therapy
  • Experimental: GDP + Epcoritamab + Epcoritamab Maintenance
    Cycles 1-3 (Cycle = 21 days) Epcoritamab will be administered by subcutaneous injection Days 1, 8, and 15 of each Cycle. Epcoritamab Day 1: 0.16mg, Day 8: 0.8mg, Day 15: 48mg except Cycle 2-Epcoritabab will administered at 48mg on Days 1, 8 and 15 Gemcitabine will be administered by IV infusion on Days 1 and 8 of each Cycle. Gemcitabine Days 1,8: 1,000mg/m\^2 Cisplatin will be administered by IV infusion on Day 1 of each Cycle. Cisplatin Day 1: 75mg/m\^2 Dexamethasone will be given by mouth on Days 1-4 of Cycle 1 ONLY. Dexamethasone Days 1-4: 40mg Cycles 4-9 (Cycle =28 Days) Epcoritamab will be administered by subcutaneous injection on Days 1, 8, and 15 of Cycles 4-9.

Primary Outcome Measure

Complete Response (CR) [ Time Frame: 4 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Varun mITTAL, MD (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer Center (Wayne State University)DetroitMichigan48201
Mary Jo O'Loughlin
[email protected]
313-578-4405
Dipenkumar Modi, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical CenterDallasTexas75390
Michael McCane
[email protected]
Elif Yilmaz, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia Health SystemCharlottesvilleVirginia22908
Sandy J Soler
[email protected]
Emily Ayers, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Indianapolis, IN

By research site
Indiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INKarmanos Cancer Center (Wayne State University)· Detroit, MIUniversity of Texas Southwestern Medical Center· Dallas, TXUniversity of Virginia Health System· Charlottesville, VA

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