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NCT05852717 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma
A Phase 2 study of Refractory Cancer and Relapsed Cancer, sponsored by Dipenkumar Modi.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 4
- Study locations
NCT05852717: Recruiting Phase 2 study of Refractory Cancer and Relapsed Cancer, sponsored by Dipenkumar Modi.
NCT05852717 is a Phase 2 study of Refractory Cancer and Relapsed Cancer that is actively recruiting participants, run by Dipenkumar Modi. The registered enrollment target is 32 participants, below the 128-participant average among 15 other Refractory Cancer trials with a reported enrollment target (75% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05852717, a Phase 2 study of Refractory Cancer and Relapsed Cancer, is actively recruiting participants, sponsored by Dipenkumar Modi.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 4
- Study locations
Study 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) 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.
Primary Outcome
CR rate is defined as proportion of subjects with a CR based on the Lugano Criteria 2022 following 3 cycles of combination treatment.
Conditions Studied
Interventions
- DRUG Epcoritamab
- PROCEDURE AutoSCT OR CAR T-cell Therapy
- DRUG GDP
Study Locations (4)
Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis
Michigan
- Karmanos Cancer Center (Wayne State University) - Detroit
Texas
- University of Texas Southwestern Medical Center - Dallas
Virginia
- University of Virginia Health System - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2023-10-31 |
| Est. Completion | 2028-11 |
| Phase | Phase 2 |
What NCT05852717 shows while recruiting
NCT05852717 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 128-participant average among 15 other Refractory Cancer trials with a reported enrollment target (75% lower).
The record links to 3 conditions, with Refractory Cancer appearing as the primary indexed condition, and to 3 interventions - of which Epcoritamab is the first listed.
NCT05852717 reports a single indexed study location in Indiana, Michigan, Texas.
Frequently Asked Questions
What is clinical trial NCT05852717 about?
NCT05852717 is a clinical study titled "Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma". 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. Epco...
What is the current status of trial NCT05852717?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2023-10-31. Estimated completion is 2028-11.
What conditions does trial NCT05852717 study?
This clinical trial studies the following conditions: Refractory Cancer, Relapsed Cancer, Large Cell Lymphoma, Diffuse.
What interventions are being tested in trial NCT05852717?
The interventions under investigation include: Epcoritamab (DRUG), AutoSCT OR CAR T-cell Therapy (PROCEDURE), GDP (DRUG).
Who is sponsoring clinical trial NCT05852717?
This trial is sponsored by Dipenkumar Modi, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05852717 being conducted?
This trial has 4 study locations across Indiana, Michigan, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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