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Chemotherapy
Polatuzumab Vedotin + R-GDP for Diffuse Large B-Cell Lymphoma
Phase 2
Recruiting
Led By Christopher Dittus, DO, MPH
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat lymphoma that has come back or not improved after other treatments.
Who is the study for?
This trial is for adults with diffuse large B-cell lymphoma that has returned after one prior treatment. They can be eligible or ineligible for a stem cell transplant, must have an ECOG Performance Status of 0-2, and show active disease on scans. Exclusions include severe allergies to monoclonal antibodies, significant heart or lung issues, hearing loss affecting daily life, pregnancy/breastfeeding intentions within a year post-treatment, and previous polatuzumab vedotin exposure.Check my eligibility
What is being tested?
The study tests the effectiveness of adding polatuzumab vedotin (PV) to the standard rrDLBCL salvage therapy regimen (rituximab-gemcitabine-dexamethasone-cisplatin). PV-RGDP aims to improve response rates in patients whose cancer returned after initial treatment. The combination isn't FDA-approved yet; this trial will assess its efficacy.See study design
What are the potential side effects?
Potential side effects may include reactions related to infusion such as fever and chills, low blood counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or tingling sensations, liver function changes, fatigue and weakness from dexamethasone use.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Complete response rate (CR)
Number of participants with adverse events
Overall Survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment7 Interventions
The subjects with diffuse large B-cell lymphoma were relapsed or refractory after the first treatment and receiving the study protocol treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyaluronidase
2007
Completed Phase 4
~370
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
Rituximab
1999
Completed Phase 4
~1880
Dexamethasone
2007
Completed Phase 4
~2590
GCSF
2009
Completed Phase 2
~350
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Who is running the clinical trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,289 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,099 Total Patients Enrolled
Christopher Dittus, DO, MPHPrincipal InvestigatorDivision of Hematology | Lymphoma Program Lineberger Comprehensive Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe infections that could increase my risk during the study.I have been treated with polatuzumab vedotin before.I can take care of myself and am up and about more than half of my waking hours.I finished my last cancer treatment at least 14 days ago and have recovered from its side effects.I have minor or no breathing issues and my oxygen levels are above 91% without assistance.I am not pregnant, breastfeeding, nor planning to become pregnant within a year after the last treatment dose.My recent scans show active cancer.I have or had another cancer that won't affect this study's treatment.I cannot take gemcitabine, cisplatin, dexamethasone, or similar medications due to adverse reactions.I have only had one previous treatment for my condition.I may or may not be eligible for a stem cell transplant using my own cells.I do not have hearing loss that affects my daily activities.I have heart problems that cause symptoms.My biopsy shows I have DLBCL or high-grade B-cell lymphoma, not Burkitt's, and it's my first relapse.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA given Polatuzumab vedotin (PV) their blessing?
"Polatuzumab vedotin (PV) is a Phase 2 drug, so there is only some data supporting its safety."
Answered by AI
Are there any current vacancies for participants in this clinical trial?
"According to the website clinicaltrials.gov, this study is not presently looking for candidates as recruitment has closed. The trial was originally posted on 10/27/2022 and last edited on 10/13/2022; however, there are 1809 other trials that patients can participate in."
Answered by AI
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