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Combination Therapy for Lymphoma
Study Summary
This trial is testing polatuzumab vedotin, rituximab, ifosfamide, carboplatin, and etoposide to see if it can effectively treat patients with relapsed or refractory diffuse large B-cell lymphoma.
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.Trial Design
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Who is running the clinical trial?
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- I have never had, nor do I currently have, a brain infection known as PML.I am not pregnant or breastfeeding.You have had serious allergic reactions to similar drugs or substances like the ones being used in the study.My cancer returned or didn't respond after one treatment including CD20 therapy and chemotherapy.I am eligible for high-dose chemotherapy and a stem cell transplant.I do not have active hepatitis B or C, or it is under control.I am on a low dose of steroids or none for my lymphoma, not exceeding 10 mg/day of prednisone or its equivalent.I am currently on medication for an infection.I have recovered from side effects of cancer treatment, except for hair loss.I can perform all my self-care but may not be able to do heavy physical work.I agree to provide tissue samples from a biopsy taken after my first treatment.I haven't used growth factors within a week before my white blood cell count test, unless my low count is due to my illness.I have been diagnosed with a specific type of lymphoma called diffuse large B-cell.My blood clotting time is normal or managed if I'm on blood thinners.My blood clotting tests are within normal limits, or if I'm on blood thinners, they're properly adjusted.I have a tumor that is larger than 1.5 cm, confirmed by a CT or PET/CT scan.I have HIV but it's under control with medication.My hemoglobin level is at least 8 g/dL without recent transfusions.I haven't had a platelet transfusion in the last 7 days.I haven't had major surgery in the last 4 weeks, except for diagnostic purposes.I agree to use birth control or not have sex to prevent pregnancy during and after the study.I have had a solid organ transplant.I have not had heart problems, stroke, or a heart attack in the last 6 months.My lymphoma has spread to my brain or spinal cord.I finished my lymphoma treatment at least 2 weeks ago.I am not a candidate for a stem cell transplant.I have no active cancer needing treatment, except possibly treated skin cancer or cervical cancer.I am capable of having children and have not been surgically sterilized.
- Group 1: Treatment (PolaR-ICE)
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- 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
Are there any limits on the amount of patients who can join this clinical trial?
"This particular clinical trial is not seeking new participants at this moment in time. The study was first posted on 18th January 2021 and received its latest update on 24th October 2022. However, there are 2776 other trials involving refractory diffuse large b cell lymphoma (dlbcl) patients that are actively recruiting right now and 1875 trials for Polatuzumab Vedotin if you're interested in alternative studies."
What are the main goals of this research project?
"The purpose of this study is to monitor the response rate to polatuzumab vedotin (Pola) added to rituximab, ifosfamide, carboplatin, and etoposide (PolaR-ICE) salvage therapy over two cycles. The primary outcome measure will be complete response (CR) rate, while secondary outcomes include progression-free survival (PFS), overall response rate (ORR), and overall survival (OS). Data will be collected using the product limit method of Kaplan and Meier, with median PFS and OS estimated when available."
Has Polatuzumab Vedotin received regulatory approval from the FDA?
"Polatuzumab Vedotin is a medication that our team has deemed as having a 2 out of 3 chance of being safe. This estimate comes from the fact that this drug is currently in Phase 2 trials, meaning there is some evidence to support safety but not efficacy."
Can people with the relevant medical condition participate in this trial right now?
"This study is no longer enrolling patients. The trial was originally posted on 1/18/2021 and last edited on 10/24/2022. However, at the moment there are 2776 other trials recruiting participants with refractory diffuse large b cell lymphoma (dlbcl) and 1875 studies for Polatuzumab Vedotin admitting patients."
Are there any other ongoing research projects utilizing Polatuzumab Vedotin?
"Polatuzumab Vedotin was initially studied at the National Institutes of Health Clinical Center in 1993. This medication has been subject to 2642 clinical trials since its inception, with 1875 of those trials still active. A large number of these ongoing studies are based out of Atlanta, Georgia."
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