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

NCT05498220 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-04-16

Study results available
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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

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 )

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Christopher Dittus, DO, MPH · Division of Hematology | Lymphoma Program Lineberger Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-17
Primary Completion
2025-03-07
Completion
2025-10-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05498220 on ClinicalTrials.gov