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ACTIVE NOT RECRUITING
NCT05498220
PHASE2

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

Sponsor: UNC Lineberger Comprehensive Cancer Center

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2023-02-17

Completion Date

2026-11-07

Last Updated

2025-09-02

Healthy Volunteers

No

Interventions

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 )

Locations (1)

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States