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NCT05498220 · ClinicalTrials.gov registry record · Phase 2
Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma
A Phase 2 study of Diffuse Large B Cell Lymphoma, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT05498220: Active Phase 2 study of Diffuse Large B Cell Lymphoma, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT05498220 is a Phase 2 study of Diffuse Large B Cell Lymphoma that is active but no longer recruiting, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 5 participants, below the 219-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05498220, a Phase 2 study of Diffuse Large B Cell Lymphoma, is active but no longer recruiting, sponsored by UNC Lineberger Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aimed to evaluate the efficacy of a novel regimen consisting of polatuzumab vedotin in combination with rituximab, gemcitabine, dexamethasone, and cisplatin (PV-RGDP) for the treatment of diffuse large B-cell lymphoma that either came back or did not improve after the treatments (rrDLBCL). This combination has not been approved by the Food and Drug Administration (FDA) for the treatment of rrDLBCL. Salvage therapy (treatment after standard treatment failed) needs to be improved. Rituximab, gemcitabine, dexamethasone, and cisplatin combination is a standard therapy for rrDLBCL and polatuzumab vedotin (PV) is a novel antibody-drug conjugate targeting CD79b. PV has shown efficacy in the setting of rrDLBCL and can improve the response rates of standard salvage therapy. This study will focus on subjects in the first relapse (one prior regimen) and will include both subjects who are transplant eligible and those who are transplant ineligible.
Primary Outcome
ORR is defined as the number of subjects who received the study treatment, and achieved complete response (CR) or partial response (PR) by Lugano classification. Complete Response: Complete metabolic response on Positron emission tomography (PET) image or Target nodes/nodal masses must regress to ≤ 1.5 cm in the largest transverse diameter (LDi) or no extra lymphatic sites of disease on Computerized Tomography (CT). Partial Response: Score of 4 or 5 with reduced uptake compared with baseline a
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Rituximab
- DRUG Gemcitabine
- DRUG Hyaluronidase
- DRUG Polatuzumab vedotin (PV)
Study Locations (1)
North Carolina
- Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2023-02-17 |
| Est. Completion | 2026-11-07 |
| Phase | Phase 2 |
What the registry record for NCT05498220 still lists
NCT05498220 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 219-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cisplatin is the first listed.
NCT05498220 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05498220 about?
NCT05498220 is a clinical study titled "Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma". This study aimed to evaluate the efficacy of a novel regimen consisting of polatuzumab vedotin in combination with rituximab, gemcitabine, dexamethasone, and cisplatin (PV-RGDP) for the treatment of diffuse large B-cell lymphoma that either came back or did not improve after the treatments (rrDLBCL)...
What is the current status of trial NCT05498220?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2023-02-17. Estimated completion is 2026-11-07.
What conditions does trial NCT05498220 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma.
What interventions are being tested in trial NCT05498220?
The interventions under investigation include: Cisplatin (DRUG), Rituximab (DRUG), Gemcitabine (DRUG), Hyaluronidase (DRUG), Polatuzumab vedotin (PV) (DRUG).
Who is sponsoring clinical trial NCT05498220?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05498220 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diffuse Large B Cell Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05498220's enrollment target sits among peer trials
5 115th of 114 the lowest of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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