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Alkylating agents

Polatuzumab Vedotin Combo for Lymphoma (POLARGO Trial)

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
Histologically-confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS) or history of transformation of indolent disease to DLBCL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up until month 2 of the post-treatment follow-up period (up to approx. 55 months)
Awards & highlights

POLARGO Trial Summary

This trial is testing a new drug for people with a certain kind of blood cancer that has come back or resisted other treatments. The new drug will be given with two other drugs that are standard for this cancer. The study has two parts, first to see if it is safe and then to see if it works better than the standard treatment.

Who is the study for?
This trial is for adults with relapsed or refractory diffuse large B-cell lymphoma who have had at least one prior therapy. They should not be planning a stem cell transplant, must agree to use contraception if of childbearing potential, and cannot have severe allergies to monoclonal antibodies or certain chemotherapy drugs.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Polatuzumab Vedotin combined with Rituximab, Gemcitabine, and Oxaliplatin (R-GemOx) against R-GemOx alone in patients whose lymphoma has returned after treatment or did not respond well to previous therapies.See study design
What are the potential side effects?
Possible side effects include allergic reactions related to infusion, nerve damage (peripheral neuropathy), low blood counts leading to increased infection risk, fatigue, liver issues, and gastrointestinal symptoms like nausea or constipation.

POLARGO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree to not have sex or use birth control and not donate sperm.
Select...
I have been diagnosed with a specific type of lymphoma (DLBCL).
Select...
My cancer came back after being gone for 6 months or never responded to treatment.
Select...
I have received at least one treatment for my condition.
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I can take care of myself and am up and about more than half of the day.

POLARGO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up until month 2 of the post-treatment follow-up period (up to approx. 55 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up until month 2 of the post-treatment follow-up period (up to approx. 55 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Stage 1: Percentage of Participants with Adverse Events (AEs)
Stage 2: Overall Survival (OS)
Secondary outcome measures
Stage 1: Best Overall Response (BOR)
Stage 1: Event Free Survival (EFS)
Stage 1: Overall Survival (OS)
+25 more
Other outcome measures
Stage 1: Observed Plasma Concentrations of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (acMMAE) and Unconjugated MMAE (ng/mL)
Stage 2: Observed Plasma Concentrations of Polatuzumab Vedotin Antibody-Conjugated Mono-Methyl Auristatin E (acMMAE) and Unconjugated MMAE (ng/mL)

POLARGO Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Pola-R-GemOx (Stage 2)Experimental Treatment4 Interventions
Participants will receive polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle administered IV and rituximab 375 mg/m^2 administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m^2 administered IV and oxaliplatin 100 mg/m^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration.
Group II: Pola-R-GemOx (Stage 1)Experimental Treatment4 Interventions
Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) for a maximum dose of 240 mg per cycle (mg/cycle) administered intravenously (IV) and rituximab 375 milligrams per square meter (mg/m^2) administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m^2 administered IV and oxaliplatin 100 mg/m^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration.
Group III: R-GemOx (Stage 2)Active Control3 Interventions
Participants will receive rituximab 375 mg/m^2 administered IV on Day 1. Participants will receive gemcitabine 1000 mg/m^2 administered IV and oxaliplatin 100 mg/m^2 administered IV on Day 2. Each cycle will consist of 21 days with up to 8 cycles of treatment administration.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Gemcitabine
2017
Completed Phase 3
~2070
Rituximab
1999
Completed Phase 4
~1880
Oxaliplatin
2011
Completed Phase 4
~2560

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,784 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,232 Total Patients Enrolled

Media Library

Gemcitabine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04182204 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Polatuzumab Vedotin completed the necessary steps for federal approval in the United States?

"Polatuzumab Vedotin has been evaluated for safety and our team rates it as a 3."

Answered by AI

How many hospitals in America are participating in this clinical research?

"There are 20 recruiting patients for this clinical trial such as Memorial Sloan Kettering - Monmouth in Middletown, St. Joseph Mercy - Brighton in Brighton, and IHA Hematology Oncology Consultants - Ann Arbor; Michigan Orthopedic Center in Ypsilanti,to name a few other locations."

Answered by AI

Are there any ongoing or previous clinical trials that have studied Polatuzumab Vedotin?

"Polatuzumab Vedotin was first studied in the year 1993 at National Institutes of Health Clinical Center, 9000 Rockville Pike. Since then there have been 2116 completed studies. There are presently 1165 active studies, with many of these trials running out of Middletown, New jersey."

Answered by AI

What are the indications for Polatuzumab Vedotin?

"Polatuzumab Vedotin can be used as a treatment for three types of cancer: diffuse large b-cell lymphoma (dlbcl), small cell lung cancer (sclc), and head and neck carcinoma."

Answered by AI

Are recruitment efforts for this trial ongoing?

"Yes, this information is accurate. The clinical trial was posted on February 7th 2020 and has been actively recruiting since. The study requires 100 patients from 3 sites."

Answered by AI

How many people are taking part in this clinical trial?

"To start the clinical trial, 216 eligible patients must enroll. These participants can come from different locations, such as Memorial Sloan Kettering - Monmouth in Middletown, New jersey and St. Joseph Mercy - Brighton in Brighton, Michigan."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
2020. "A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04182204.
~25 spots leftby Sep 2024
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