Polatuzumab vedotin (PV) for Diffuse Large B-cell Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Lineberger Comprehensive Cancer Center, Chapel Hill, NC
Diffuse Large B-cell Lymphoma+3 More
Polatuzumab vedotin (PV) - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Diffuse Large B-cell Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Diffuse Large B-cell Lymphoma

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Up to 2 years

Up to 2 years
Number of participants with adverse events
Overall Survival (OS)
Progression free survival (PFS)
Month 4
Complete response rate (CR)
Overall response rate (ORR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Diffuse Large B-cell Lymphoma

Trial Design

1 Treatment Group

Single Arm
1 of 1
Experimental Treatment

44 Total Participants · 1 Treatment Group

Primary Treatment: Polatuzumab vedotin (PV) · No Placebo Group · Phase 2

Single ArmExperimental Group · 7 Interventions: Hyaluronidase, Gemcitabine, GCSF, Polatuzumab vedotin (PV), Dexamethasone, Cisplatin, Rituximab · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyaluronidase
2007
Completed Phase 4
~370
Gemcitabine
2017
Completed Phase 3
~2940
GCSF
2009
Completed Phase 2
~350
Dexamethasone
2007
Completed Phase 4
~2420
Cisplatin
2013
Completed Phase 3
~3340
Rituximab
1999
Completed Phase 3
~1510

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Closest Location: Lineberger Comprehensive Cancer Center · Chapel Hill, NC
2007First Recorded Clinical Trial
1 TrialsResearching Diffuse Large B-cell Lymphoma
22 CompletedClinical Trials

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,482 Previous Clinical Trials
563,301 Total Patients Enrolled
1 Trials studying Diffuse Large B-cell Lymphoma
9 Patients Enrolled for Diffuse Large B-cell Lymphoma
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
303 Previous Clinical Trials
71,303 Total Patients Enrolled
2 Trials studying Diffuse Large B-cell Lymphoma
40 Patients Enrolled for Diffuse Large B-cell Lymphoma
Christopher Dittus, DO, MPHPrincipal InvestigatorDivision of Hematology | Lymphoma Program Lineberger Comprehensive Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Subjects must be 18 years of age or older.
You have a performance status of 0-2.
You are eligible for autologous stem cell transplant.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.