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Chemotherapy
Polatuzumab Vedotin + Rituximab for B-Cell Lymphoma
Phase 2
Recruiting
Led By Patrick Reagan
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- One cycle of anthracycline containing chemotherapy such as R-CHOP or R-miniCHOP given urgently for aggressive disease.
Histologically-confirmed DLBCL, NOS, NOS, high grade B-cell lymphoma with MYC, BCL2 and/or BCL6 rearrangements, high grade B-cell lymphoma, NOS, and grade 3b follicular lymphoma by 2016 WHO classification by site hematopathologist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of enrollment until date of death from any cause up to 24 months
Awards & highlights
Study Summary
This trial is testing a new cancer drug in patients 75 and older with a specific type of lymphoma.
Who is the study for?
This trial is for men and women aged 75 or older with DLBCL, including those who've had certain prior treatments for indolent lymphoma but not an anthracycline regimen. They must have adequate organ function, no serious medical issues that could affect the study, and agree to contraception if applicable.Check my eligibility
What is being tested?
The effectiveness and safety of polatuzumab vedotin combined with R-miniCHP (rituximab, cyclophosphamide, doxorubicin hydrochloride hydrate [doxorubicin], prednisone) are being tested in patients over 75 years old with diffuse large B-cell lymphoma (DLBCL).See study design
What are the potential side effects?
Potential side effects include reactions related to infusion of the drugs, changes in blood counts leading to increased infection risk or bleeding problems, possible damage to organs like the heart or liver from chemotherapy drugs, and nerve damage causing numbness or tingling.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received one cycle of a specific chemotherapy for my aggressive disease.
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My lymphoma diagnosis fits specific types identified by a 2016 classification.
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I am 75 years old or older.
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I can care for myself but may not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of enrollment until date of death from any cause up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of enrollment until date of death from any cause up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival
Secondary outcome measures
Overall Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental: Polatuzumab Vedotin and R-CHOPExperimental Treatment5 Interventions
The dose of polatuzumab vedotin for each patient will be 1.8 mg/kg (IV for 21 days)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~1880
Cyclophosphamide
1995
Completed Phase 3
~3770
Doxorubicin
2012
Completed Phase 3
~7940
Prednisone
2014
Completed Phase 4
~2370
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
840 Previous Clinical Trials
534,211 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,104 Total Patients Enrolled
Patrick ReaganPrincipal InvestigatorUniversity of Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received one cycle of a specific chemotherapy for my aggressive disease.I am not suitable for standard R-CHOP treatment due to my age or health conditions.I have completed treatment for my stage 1 cancer.I had another cancer but have been in remission for over 3 years without treatment.I am currently on dialysis.I have had a stem cell transplant from a donor.I understand the need for reliable contraception or have considered sperm banking.I have not been treated for aggressive B-cell lymphoma or HT before.My bilirubin levels are within the normal range, or slightly higher if due to specific conditions.My kidney function, measured by creatinine clearance, is good.I have received treatment for lymphoma symptoms with specific medications.My platelet count is at least 75,000, unless it's low due to my aggressive B-cell lymphoma.My lymphoma diagnosis fits specific types identified by a 2016 classification.I have active hepatitis B.I am 75 years old or older.My white blood cell count is healthy for treatment.I have mild to severe nerve damage in my hands or feet.I understand the study details and am willing to sign the consent form.I have another active cancer that might affect the study's results.You have had an organ transplant in the past, or have a condition called post-transplant lymphoproliferative disorder.My diagnosis is either primary mediastinal B-cell lymphoma or EBV positive DLBCL.My heart's pumping ability is significantly reduced.I can care for myself but may not be able to do heavy physical work.I agree to either not have sex or use a condom, and not donate sperm.My biopsy confirmed I have a transformed lymphoma and I haven't had anthracycline treatment.I will not have unprotected sex or donate sperm for 5 months after my last dose.I have low grade prostate cancer and am being monitored without active treatment.My lymphoma has both slow-growing and aggressive features.I have only had anthracycline once for urgent lymphoma treatment.I have or had lymphoma in my brain or spinal cord.I have taken corticosteroids for lymphoma symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Polatuzumab Vedotin and R-CHOP
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.
What are Polatuzumab vedotin's primary indications?
"Polatuzumab vedotin is an effective treatment for lung cancer, thyroiditis, and polyangium."
Answered by AI
Has Polatuzumab vedotin been cleared for use by the FDA?
"Polatuzumab vedotin's safety is supported by Phase 2 clinical data, but there is currently no efficacy data, so it received a score of 2."
Answered by AI
How many people are eligible to enroll in this trial at most?
"That is correct, the listing on clinicaltrials.gov does show that this particular trial is looking for enrolment from patients. The original posting date was September 20th 2021 with the most recent update being January 6th 2022. There is a need for 39 participants at 1 location."
Answered by AI
Is this study presently looking for new participants?
"The trial, which was posted on September 20th 2021 and updated January 6th 2022 according to clinicaltrials.gov, is still recruiting patients for the study."
Answered by AI
Are there other similar studies to the one involving Polatuzumab vedotin?
"Polatuzumab vedotin is currently being trialled in 1468 ongoing studies, with 310 of those trials in Phase 3. Many of the locations for these trials are situated in Bethesda, Maryland; however, there are 51307 total trial sitesfor Polatuzumab vedotin."
Answered by AI
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