NCT05498220

Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma

A Phase II Trial Evaluating the Efficacy of Polatuzumab Vedotin With Rituximab, Gemcitabine, Dexamethasone, and Cisplatin (PV-RGDP) Chemotherapy for Relapsed or Refractory Diffuse Large B-cell Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Polatuzumab vedotin (PV)	1.8 mg/kg, intravenous, at day 1, in every 21 days
DRUG	Rituximab	375 mg/m2 intravenous, at day 1 or day 2, in every 21 days
DRUG	Hyaluronidase	1,400 mg/23,400 units sub-cutaneous, starts at cycle 2, in every 21 days
DRUG	Gemcitabine	1,000 mg/m2 intravenous at day 1 and 8, in every 21 days
DRUG	Cisplatin	75 mg/m2, intravenous, at day 1, in every 21 days
DRUG	Dexamethasone	40 mg intravenous at day 1, Per oral days at days 2-4
DRUG	GCSF	granulocyte-colony stimulating factor (GCSF )

Timeline

• Start date: 2023-02-17
• Primary completion: 2025-03-07
• Completion: 2025-10-03
• First posted: 2022-08-11
• Last updated: 2026-04-16
• Results posted: 2026-04-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study