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Alkylating agents
Polatuzumab Vedotin + Chemotherapy for Large B-Cell Lymphoma
Phase 1
Recruiting
Led By Ryan Lynch
Research Sponsored by University of Washington
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 30 days after last dose of polatuzumab or first administration of alternate therapy
Awards & highlights
Study Summary
This trial is testing polatuzumab vedotin, a new treatment for aggressive large B-cell lymphoma, in combination with other drugs.
Who is the study for?
This trial is for adults with untreated aggressive large B-cell lymphoma. Participants must have proper kidney and liver function, no severe allergies to monoclonal antibodies or chemotherapy components, and agree to use effective contraception. Those with prior systemic treatment for lymphoma (except corticosteroids), certain other health conditions, or who are pregnant cannot join.Check my eligibility
What is being tested?
The trial tests polatuzumab vedotin combined with chemotherapy drugs like cyclophosphamide, doxorubicin, etoposide, prednisone, rituximab against aggressive large B-cell lymphoma. Polatuzumab vedotin targets cancer cells specifically to deliver a toxic agent that kills them.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, low blood cell counts leading to increased infection risk or bleeding problems, fatigue, nausea and vomiting from chemotherapy drugs. Liver or kidney function may also be affected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after last dose of polatuzumab or first administration of alternate therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after last dose of polatuzumab or first administration of alternate therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
The proportion of patients who are unable to complete 6 cycles of therapy for reasons other than disease progression
Side effects data
From 2016 Phase 2 & 3 trial • 86 Patients • NCT030020384%
Gastrointestinal intolerance
2%
Impaired liver function test
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azathioprine
Rituximab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (polatuzumab vedotin, combination chemotherapy)Experimental Treatment7 Interventions
Patients receive rituximab IV on day 1, polatuzumab vedotin IV on day 1, prednisone PO BID on days 1-5, etoposide IV on days 1-4, doxorubicin IV on days 1-4, and cyclophosphamide IV on day 5. Patients also receive filgrastim SC 24-72 hours after the last dose of each treatment cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Cyclophosphamide
1995
Completed Phase 3
~3770
Filgrastim
2000
Completed Phase 3
~3670
Rituximab
1999
Completed Phase 4
~1880
Etoposide
2010
Completed Phase 3
~2440
Doxorubicin
2012
Completed Phase 3
~7940
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,847,888 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,849 Total Patients Enrolled
Ryan LynchPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
4 Previous Clinical Trials
69 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My CLL/SLL has transformed into a more aggressive form.I have had cancer before, but it might not affect my eligibility.I have an aggressive type of large B-cell lymphoma that hasn't been treated.I do not have any major uncontrolled health conditions.I can take care of myself and am up and about more than 50% of my waking hours.I have had a brain infection called progressive multifocal leukoencephalopathy.My heart's pumping ability is normal or above.I cannot take certain medications due to adverse reactions.I have been diagnosed with Burkitt lymphoma.I have had an organ transplant.I have mild to no nerve damage symptoms.I have received treatment for lymphoma, but not including corticosteroids.I have received treatment for a slow-growing type of lymphoma.I have had major surgery recently.I have recently used monoclonal antibodies or been part of a drug trial.I am currently on medication for an infection.My HIV infection is not under control.I am scheduled for a full course of chemoimmunotherapy.I am 18 years old or older.I have taken a pregnancy test and it was negative.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (polatuzumab vedotin, combination chemotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many test subjects are participating in the ongoing clinical trial?
"Confirmed. Evidently, this clinical trial is currently enrolling participants - it was published on October 27th 2020 and last revised on November 22nd 2022. The investigators are recruiting 50 patients from a single medical centre."
Answered by AI
To what maladies is Rituximab typically prescribed?
"Rituximab is often utilized to treat merkel cell cancer but it has been proven effective for a variety of other medical conditions including ophthalmia, sympathetic, and prostate cancer."
Answered by AI
Is there still availability for participants in this experiment?
"Affirmative. Clinicaltrials.gov indicates that this trial, which was initially published on October 27th 2020, is actively recruiting individuals for participation. 50 participants need to be enrolled from a single site."
Answered by AI
What other exploratory investigations have been conducted concerning Rituximab?
"Presently, 1674 investigations are being conducted on Rituximab. Of those trials, 366 have advanced to the Phase 3 stage at this time. Although most studies occur in Bethesda, Maryland, there are 61190 sites administering tests for this medication worldwide."
Answered by AI
Has Rituximab been granted sanction from the FDA?
"Due to the limited clinical data on Rituximab, its safety rating is only 1. This is a Phase 1 trial after all, so there are no guarantees of efficacy or safety."
Answered by AI
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