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Alkylating agents

Combination Therapy for Lymphoma

Phase 2
Waitlist Available
Led By Alex F Herrera
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) =< 2
Fully recovered from the acute toxic effects (except alopecia) to =< grade 1 to prior anti-cancer therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

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.

Who is the study for?
This trial is for adults with relapsed or refractory diffuse large B-cell lymphoma who have had one prior treatment including CD20-directed immunotherapy and chemotherapy. They must be in good enough health to undergo high-dose chemotherapy followed by a stem cell transplant, not have severe allergies to similar drugs, no active infections or other cancers, and agree to use birth control.Check my eligibility
What is being tested?
The PolaR-ICE trial tests a combination of polatuzumab vedotin (an antibody-drug conjugate), rituximab (an antibody), and chemotherapy agents ifosfamide, carboplatin, and etoposide as initial salvage therapy. It aims to see if this mix can better kill cancer cells in patients whose disease returned or resisted previous treatment.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, low blood counts leading to increased infection risk or bleeding problems, fatigue, nerve damage causing numbness or tingling sensations, liver issues reflected in blood tests changes, allergic reactions and potential harm to unborn babies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can perform all my self-care but may not be able to do heavy physical work.
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I have recovered from side effects of cancer treatment, except for hair loss.
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I have been diagnosed with a specific type of lymphoma called diffuse large B-cell.
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My blood clotting tests are within normal limits, or if I'm on blood thinners, they're properly adjusted.
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I have a tumor that is larger than 1.5 cm, confirmed by a CT or PET/CT scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response (CR) rate of polatuzumab vedotin (Pola) added to rituximab, ifosfamide, carboplatin, and etoposide (PolaR-ICE) salvage therapy
Incidence of toxicity of PolaR-ICE salvage therapy
Secondary outcome measures
CR rate among patients who were PR at autologous stem cell transplant (ASCT)
Incidence of toxicity of single-agent polatuzumab vedotin (Pola) consolidation therapy
Overall response rate (ORR) to PolaR-ICE
+3 more
Other outcome measures
Biomarker analysis
Circulating tumor deoxyribonucleic acid (ctDNA) analysis

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (PolaR-ICE)Experimental Treatment5 Interventions
SALVAGE THERAPY: Patients receive polatuzumab vedotin IV on day 1, rituximab IV on day 1, etoposide IV on days 1-3, carboplatin IV on day 2, and ifosfamide IV on day 2 or days 1-3. Treatment repeats every 21 days for up to 2-3 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response, partial response or stable disease by C2D15 may receive 1 additional cycle of PolaR-ICE IV. CONSOLIDATION THERAPY: Within 30-60 days after ASCT, patients receive polatuzumab vedotin IV on day 1. Treatment repeats every 21 days for up to 3-4 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
FDA approved
Ifosfamide
FDA approved
Carboplatin
FDA approved
Beta-D-Glucose
Not yet FDA approved
Polatuzumab vedotin
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,626 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,419 Total Patients Enrolled
Alex F HerreraPrincipal InvestigatorCity of Hope Medical Center
11 Previous Clinical Trials
1,520 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04665765 — Phase 2
Large B-Cell Lymphoma Research Study Groups: Treatment (PolaR-ICE)
Large B-Cell Lymphoma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04665765 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04665765 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

What are the main indications for treatment with Polatuzumab Vedotin?

"Polatuzumab Vedotin is an effective initial treatment for Merkel cell cancer, leukemia, and other cancers."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~10 spots leftby Apr 2025