What side effects are associated with this type of intervention?

Common treatments for Large B-Cell Lymphoma, such as Polatuzumab Vedotin, often involve targeted therapies and chemotherapy combinations. Polatuzumab Vedotin, which targets CD79b positive cancer cells, can cause side effects including peripheral neuropathy, neutropenia, thrombocytopenia, anemia, and fatigue. Other similar treatments, like Rituximab combined with chemotherapy agents (e.g., ifosfamide, carboplatin, and etoposide), may result in additional side effects such as infusion reactions, infections, gastrointestinal disturbances, and myelosuppression. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Polatuzumab Vedotin is an FDA-approved treatment for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that targets CD79b positive cancer cells. Similar FDA-approved treatments include Rituximab, a monoclonal antibody that targets CD20 on B-cells, often used in combination with chemotherapy agents like cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP regimen). Another related drug is Brentuximab Vedotin, which targets CD30 and is used for certain types of lymphoma. These treatments utilize targeted delivery mechanisms to improve efficacy and reduce toxicity.

What other types of research exist?

Promising novel alternatives to Polatuzumab Vedotin for Large B-Cell Lymphoma patients include: 1) CAR T-cell therapies such as Axicabtagene Ciloleucel and Tisagenlecleucel, which have shown significant efficacy in relapsed/refractory DLBCL. 2) Bispecific antibodies like Glofitamab and Epcoritamab, which target CD20 and CD3, engaging T-cells to kill lymphoma cells. 3) Novel small molecules such as Selinexor, a selective inhibitor of nuclear export, which has shown activity in DLBCL. These therapies represent cutting-edge advancements and offer new hope for patients.

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Alkylating agents

Combination Therapy for Lymphoma

Q: What is the mechanism of action of this treatment?

The most common treatments for Large B-Cell Lymphoma include targeted therapies, monoclonal antibodies, and chemotherapy. Polatuzumab Vedotin is a targeted therapy that combines a monoclonal antibody (polatuzumab) with a cytotoxic agent (vedotin). The antibody specifically binds to CD79b, a protein expressed on the surface of B-cell lymphoma cells, allowing for targeted delivery of vedotin, which kills the cancer cells. This targeted approach minimizes damage to healthy cells and reduces side effects. Monoclonal antibodies like rituximab target CD20 on B-cells, marking them for destruction by the immune system. Chemotherapy drugs, such as ifosfamide, carboplatin, and etoposide, work by killing rapidly dividing cells, including cancer cells. These treatments are crucial for Large B-Cell Lymphoma patients as they offer more effective and less toxic options compared to traditional chemotherapy alone.

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

Must not have

History of or current progressive multifocal leukoencephalopathy (PML)

Females only: Pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Approved for 20 Other Conditions

No Placebo-Only Group

Summary

This trial studies a combination of drugs to treat patients with diffuse large B-cell lymphoma that has come back or did not respond to previous treatments. The treatment includes a targeted drug that delivers a toxin to cancer cells, an antibody that stops cancer growth, and chemotherapy drugs that kill or stop the division of cancer cells. The goal is to see if this combination is safe and effective.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have never had, nor do I currently have, a brain infection known as PML.

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I am not pregnant or breastfeeding.

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I am currently on medication for an infection.

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I haven't had major surgery in the last 4 weeks, except for diagnostic purposes.

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I have had a solid organ transplant.

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I have not had heart problems, stroke, or a heart attack in the last 6 months.

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My lymphoma has spread to my brain or spinal cord.

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I am not a candidate for a stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Response (CR) Rate After Two Cycles of PolaR-ICE Salvage Therapy

Number of Unacceptable Toxicities of PolaR-ICE Salvage Therapy (Phase 2 Stage)

Number of Unacceptable Toxicities of PolaR-ICE Salvage Therapy (Safety lead-in Stage)

Secondary study objectives

Overall Response Rate (ORR) of the PolaR-ICE Salvage Therapy

Other study objectives

Biomarker analysis

Circulating tumor deoxyribonucleic acid (ctDNA) analysis

Awards & Highlights

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.

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

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Large B-Cell Lymphoma include targeted therapies, monoclonal antibodies, and chemotherapy. Polatuzumab Vedotin is a targeted therapy that combines a monoclonal antibody (polatuzumab) with a cytotoxic agent (vedotin). The antibody specifically binds to CD79b, a protein expressed on the surface of B-cell lymphoma cells, allowing for targeted delivery of vedotin, which kills the cancer cells. This targeted approach minimizes damage to healthy cells and reduces side effects. Monoclonal antibodies like rituximab target CD20 on B-cells, marking them for destruction by the immune system. Chemotherapy drugs, such as ifosfamide, carboplatin, and etoposide, work by killing rapidly dividing cells, including cancer cells. These treatments are crucial for Large B-Cell Lymphoma patients as they offer more effective and less toxic options compared to traditional chemotherapy alone.