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Polatuzumab Vedotin + Chemotherapy for Richter Syndrome
Study Summary
This trial is testing a new cancer drug, Polatuzumab vedotin, to see if it is effective and safe when combined with other existing cancer drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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 • NCT01691898Trial Design
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Who is running the clinical trial?
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- I have not had major surgery in the last 4 weeks, except for minor lymph node biopsies.I do not have any major health issues that could interfere with the study.I agree to follow strict birth control measures or remain abstinent during and for 5 months after treatment.I am HIV positive.I have moderate to severe numbness, tingling, or pain in my hands or feet.I do not have any current infections or major infections in the last 4 weeks.I have active hepatitis C or B, or had hepatitis B with a negative PCR.I had cancer before, but it was treated and hasn't come back in 3 years, except for non-melanoma skin or cervical cancer.I agree to use effective birth control or remain abstinent during and for 12 months after the study.I am currently on targeted CLL therapy but haven't changed or added new treatments recently.My blood tests show normal bone marrow function.I can perform all self-care but may not be able to work.You are expected to live for at least 6 months.I have CLL that has transformed into DLBCL, confirmed by a biopsy.I do not have serious heart conditions like recent heart attacks or unstable heart disease.My cancer has spread to my brain or central nervous system.I am 18 years old or older.I have received treatment for Richter's transformation before.I had a stem cell transplant for CLL less than 6 months ago.My condition is Richter's Transformation, not the DLBCL type.You have had serious allergic reactions in the past to certain types of medications called humanized or murine monoclonal antibodies.
- Group 1: Polatuzumab vedotin plus R-EPCH
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is enrollment still open for this investigation?
"Affirmative. The information available on clinicaltrials.gov attests that this medical study, which was initially shared on September 24th 2021, is actively seeking participants. Specifically, 20 individuals need to be enrolled from one location."
What is the current enrollment capacity for this clinical trial?
"Affirmative. Clinicaltrials.gov confirms that this medical trial, uploaded on September 24th 2021, is actively enrolling patients for participation. Currently, 20 participants must be found among 1 site."
Has the Federal Drug Administration sanctioned Polatuzumab Vedotin?
"Our team at Power evaluated the safety of Polatuzumab Vedotin and assigned it a rating of 2, as this is only in Phase 2 trials; indicating that there exists some evidence for its safety but no studies showing efficacy."
Has Polatuzumab Vedotin been tested in any prior research experiments?
"Presently, 1570 studies in regards to Polatuzumab Vedotin are ongoing. Of these trials, 346 are at the Phase 3 stage and 59006 different medical sites have been tapped for research purposes - with Bethesda, Maryland serving as a major hub of activity."
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