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Polatuzumab Vedotin + R-CHP vs R-CHOP for Diffuse Large B-Cell Lymphoma (POLARIX Trial)
POLARIX Trial Summary
This trial will compare the effects of two different treatments for people with a type of blood cancer called diffuse large B-cell lymphoma.
POLARIX Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPOLARIX Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 1 & 2 trial • 231 Patients • NCT01691898POLARIX Trial Design
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Who is running the clinical trial?
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- I have had treatment for DLBCL, but only a node biopsy.I have not received any live vaccines in the last 28 days.I do not have any active infections or significant infections in the last 2 weeks.I have been diagnosed with a specific type of lymphoma in the chest area.I have been diagnosed with Burkitt lymphoma.I haven't taken cancer-killing drugs or anti-CD20 antibodies in the last 5 years.I cannot take CHOP chemotherapy due to allergies or past reactions.I take more than 30 mg/day of prednisone or its equivalent for reasons other than lymphoma symptom control.I have no other cancers that could interfere with this study.I have the demyelinating type of Charcot-Marie-Tooth disease.I have a specific type of lymphoma affecting my brain, skin, or body cavities.I haven't used any monoclonal antibody treatments in the last 3 months.I do not have major heart or lung diseases that could interfere with the study.I have had progressive multifocal leukoencephalopathy in the past.I am able to care for myself and perform daily activities.My heart pumps well, with an ejection fraction of 50% or more.I might have active or latent tuberculosis.I have CD20-positive DLBCL and have not been treated for it.I agree to use birth control or remain abstinent and not donate eggs.I agree to not have unprotected sex or donate sperm.I can provide samples of my tumor either from previous or new biopsies.I have had radiation therapy to the chest area near the heart.I haven't had major surgery in the last 4 weeks, except for diagnostic purposes.I do not have significant liver problems like hepatitis, alcohol abuse, or cirrhosis.I have tested positive for HTLV-1.I have a history of slow-growing lymphoma.My blood counts are within normal ranges.My diagnosis is grey-zone lymphoma, between DLBCL and Hodgkin.I have had an organ transplant.I have been diagnosed with a specific type of lymphoma called follicular lymphoma grade 3B.I have nerve damage in my hands or feet that affects my daily activities.
- Group 1: R-CHOP plus Polatuzumab Vedotin Placebo
- Group 2: R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What is the total subject pool for this clinical research?
"Unfortunately, this study is no longer admitting patients. The trial was originally posted on November 16th, 2017 and the last update was on August 29th, 2022. There are presently 1816 other clinical trials for diffuse large b-cell lymphoma (dlbcl) and 1489 trials for Polatuzumab Vedotin that are actively recruiting participants."
In how many different medical facilities is this research being conducted today?
"64 patients are currently enrolled, with CancerCare Manitoba (CCMB) in Winnipeg, Texas Oncology San Antonio Medical Center in San Antonio, and Oncology Associates of Southwest Virginia, Inc. in Blacksburg being some of the notable enrolment sites. There are also 64 other locations where patients have joined this trial."
What are the most similar trials to Polatuzumab Vedotin in terms of purpose and design?
"Polatuzumab Vedotin was first researched in 1993 at the National Institutes of Health Clinical Center. As of now, there have been 2421 completed clinical trials and 1489 ongoing studies. A large portion of these live trials are being conducted out of Winnipeg, Manitoba."
Has Polatuzumab Vedotin completed the necessary steps for FDA approval?
"Polatuzumab Vedotin has received a 3 for safety from our team at Power. This is because Polatuzumab Vedotin is in Phase 3 trials, which means that though there is data supporting efficacy, multiple rounds of tests have been conducted to support safety."
What are the conditions that Polatuzumab Vedotin is approved to treat?
"Polatuzumab Vedotin can be used to attack and eliminate lung cancers, small cell lung cancer (sclc), as well as thyroiditis."
Are we looking for more people to participate in this experiment?
"This trial is no longer recruiting patients. The last update to the posting was on 8/29/2022 and it was first posted on 11/16/2017. There are 1816 other trials currently enrolling patients with diffuse large b-cell lymphoma (dlbcl) and 1489 trials for Polatuzumab Vedotin that are actively seeking patients."
Can adults of any age participate in this research project?
"In order to take part in this clinical trial, patients must be aged between 18-80. There are 697 other studies for those under 18 and 2861 for seniors."
How can I sign up to help test this new medication?
"This study is looking for 1000 participants that have diffuse large b-cell lymphoma (dlbcl) and are between 18-80 years old. The most important requirements for applicants are as follows: Must be able to provide either archival or freshly collected tumor tissue, Male participants must agree to use a condom during intercourse and not donate sperm, Participants must be previously untreated with CD20-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS) including germinal center B-cell type, activated B"
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