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Alkylating agents
Polatuzumab Vedotin + Combination Chemotherapy for Lymphoma
Phase 2
Recruiting
Led By Dipenkumar Modi, M.D.
Research Sponsored by Barbara Ann Karmanos Cancer Institute
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 12 months
Awards & highlights
Study Summary
This trial is testing polatuzumab vedotin in combination with chemotherapy to treat patients with previously untreated double or triple hit lymphoma.
Who is the study for?
This trial is for patients with previously untreated high-grade B-cell lymphoma, including double or triple hit and double expressor subtypes. Participants must have a measurable lesion, normal heart function (LVEF >= 45%), adequate blood counts, and agree to use effective contraception if of childbearing potential. They should be able to follow the study protocol and have a life expectancy of at least 24 weeks.Check my eligibility
What is being tested?
The trial is testing polatuzumab vedotin combined with chemotherapy drugs like rituximab, cyclophosphamide, doxorubicin hydrochloride, and prednisone against lymphoma. The goal is to see if this combination works better than standard chemotherapy alone in treating aggressive forms of B-cell lymphoma.See study design
What are the potential side effects?
Possible side effects include reactions related to the infusion process, damage to healthy cells causing low blood counts leading to increased infection risk or bleeding problems, fatigue from treatment burden on the body's resources, organ inflammation due to immune system activation by monoclonal antibodies like polatuzumab vedotin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of complete remission
Secondary outcome measures
Duration of response (DOR)
Incidence of adverse events
Overall response rate (ORR)
+1 moreOther outcome measures
Biomarker assessment
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (polatuzumab vedotin, R-CHP)Experimental Treatment7 Interventions
Patients receive prednisone PO, prednisolone IV, or methylprednisolone IV on days 1-5. Patients also receive rituximab IV, polatuzumab vedotin IV over 30-90 minutes, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1. 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
Cyclophosphamide
1995
Completed Phase 3
~3770
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Prednisolone
2005
Completed Phase 4
~2720
Methylprednisolone
2015
Completed Phase 4
~2280
Prednisone
2014
Completed Phase 4
~2370
Rituximab
1999
Completed Phase 4
~1880
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Find a Location
Who is running the clinical trial?
Barbara Ann Karmanos Cancer InstituteLead Sponsor
163 Previous Clinical Trials
9,207 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,498 Total Patients Enrolled
Dipenkumar Modi, M.D.Principal Investigator - Barbara Ann Karmanos Institute
Barbara Ann Karmanos Cancer Institute
3 Previous Clinical Trials
104 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot participate if you have had a severe allergic reaction to any of the drugs in the treatment plan or have an allergy to ingredients used to make the drugs.You have had other types of cancer that could make it harder to follow the rules of this study or understand the results. There are some exceptions, but not all types of cancer are allowed.You have a certain type of high-grade B-cell lymphoma called HGBL NOS subtype.You have not received any treatment for cancer with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy or experimental drugs before starting the clinical trial, except for some specific cases.You have a type of lymphoma called primary mediastinal (thymic) large B-cell lymphoma.You have Burkitt lymphoma.You have a type of lymphoma called double expressor lymphoma, which is identified by certain proteins being overproduced in your body.Before starting treatment, the study team needs to confirm that they have a tissue sample from your tumor. They may start your treatment before the sample is verified, but they will check the sample's quality as soon as possible.You have a tumor that can be measured by CT scan or MRI and is at least 1.5 cm in size.You are expected to live for at least 24 more weeks.You have read and signed a form that shows you understand the study and agree to participate.You have a type of lymphoma called double hit lymphoma (DHL) or triple hit lymphoma (THL) confirmed by a special test called fluorescence in situ hybridization (FISH). This means that certain genes in your cells are not working properly.You are able to perform your daily activities with minimal to no assistance.You have a type of lymphoma called high grade B-cell lymphoma with specific genetic changes involving MYC and BCL2 and/or BCL6.The study requires a sample of your tissue from a previous biopsy or surgery. It can be in the form of a tissue block or slides. The study team will need to review your pathology report and confirm your diagnosis before you can participate. If the initial sample is not sufficient, additional samples may be needed.You have any underlying medical condition that may affect the safety or accuracy of the study results.Taking Evushield or other anti-viral medications after exposure to COVID-19 will not disqualify you from participating in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (polatuzumab vedotin, R-CHP)
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.
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