What side effects are associated with this type of intervention?

Dendritic cell therapy for Non-Hodgkin's Lymphoma can cause flu-like symptoms, injection site reactions, and fatigue. Cryosurgery may lead to localized pain, swelling, and potential damage to nearby tissues. Pembrolizumab, a monoclonal antibody, is associated with immune-related adverse events such as skin reactions, endocrine disorders, pneumonitis, and colitis. These treatments aim to leverage the body's immune system to target cancer cells but come with a range of potential side effects that need to be managed carefully.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma that align with the mechanisms being studied in the trial involving dendritic cell therapy, cryosurgery, and pembrolizumab. Rituximab, a monoclonal antibody targeting CD20 on B-cells, was one of the first immunotherapies approved for NHL, enhancing the immune system's ability to attack cancer cells. More recently, CAR T-cell therapies such as axicabtagene ciloleucel and tisagenlecleucel have been approved, which involve modifying a patient's T-cells to better target and kill lymphoma cells. While cryosurgery is less commonly used in NHL, it remains a valuable option for localized treatment. Pembrolizumab, an anti-PD-1 monoclonal antibody, is being explored for its potential to enhance immune response in NHL, although it is more commonly approved for other cancers.

What other types of research exist?

Promising novel alternatives for treating Non-Hodgkin's Lymphoma in 2024 include CAR T-cell therapy, bispecific T-cell engagers (BiTEs), and novel immune checkpoint inhibitors like nivolumab and ipilimumab. CAR T-cell therapy involves modifying a patient's T-cells to target cancer cells, while BiTEs are designed to direct T-cells to cancer cells. These therapies have shown significant efficacy in clinical trials and represent advanced options for NHL treatment.

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Vaccine

Combination Immunotherapy for Non-Hodgkin Lymphoma

Phase 1 & 2

Waitlist Available

Led By Yi Lin, MD, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Transformed FL must have had therapy for FL and be refractory to chemotherapy for DLBCL

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Must not have

Active CNS malignancy

Evidence of interstitial lung disease or active, non-infectious pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests a combination of a personalized vaccine, a freezing technique to kill cancer cells, and an immune-boosting drug in patients with non-Hodgkin lymphoma. The goal is to improve treatment effectiveness by enhancing the immune response and directly targeting cancer cells.

Who is the study for?

Adults with biopsy-proven non-Hodgkin lymphoma, excluding certain types, who have undergone previous treatments (at least one regimen for indolent NHL or two regimens for aggressive NHL) can join. They must have measurable lesions suitable for cryoablation and vaccine injections, be in good physical condition (ECOG PS 0 or 1), and meet specific blood count and organ function criteria. Pregnant women, nursing mothers, those with severe diseases or active malignancies requiring treatment are excluded.

What is being tested?

The trial is testing the combination of dendritic cell therapy made from a patient's own tumor cells and white blood cells, cryosurgery to freeze cancer cells, and pembrolizumab—an antibody that may boost the immune system's attack on cancer. The study aims to determine the best dose and assess side effects while evaluating how well this approach treats non-Hodgkin lymphoma.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in various organs; infusion-related reactions; fatigue; possible complications from cryosurgery like damage to nearby tissues; plus general risks associated with vaccines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My follicular lymphoma has become resistant to treatment after transforming.

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I am fully active or can carry out light work.

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I have a slow-growing type of non-Hodgkin lymphoma and have been treated with a rituximab-based therapy.

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I have aggressive non-Hodgkin lymphoma and have undergone at least 2 treatment regimens.

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I have aggressive NHL and have been treated with an anti-CD20 drug, unless my tumor doesn't have CD20.

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I have aggressive non-Hodgkin lymphoma and cannot or have not undergone a stem cell transplant.

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I am 18 years old or older.

Exclusion Criteria

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

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I have an active brain or spinal cord tumor.

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I have a lung condition not caused by an infection.

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I haven't had chemotherapy or radiation in the last 2 weeks and have recovered from side effects.

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I have an autoimmune disease like Crohn's or lupus and needed treatment recently or have a hard-to-control history.

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I am currently breastfeeding.

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I have not had major surgery within the last 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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

Maximum tolerated dose (MTD)

Combined Modality Therapy

Secondary study objectives

Complete response

Duration of response

Incidence of adverse events

+4 more

Other study objectives

Change in immunologic correlates

Radiologic analysis

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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 (pembrolizumab, dendritic cell therapy, cryosurgery)Experimental Treatment6 Interventions

Patients receive pembrolizumab IV on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive dendritic cell therapy IT on days 2, 8, and 15 of cycles 2 and 3, and day 2 of cycles 4 and 5. Patients undergo cryosurgery on day 2 of cycle 2 and receive pneumococcal 13-valent conjugate vaccine by injection on day 2 of cycles 2-5. Treatment repeats every 21 days for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients who are CR, PR, or SD after completion of therapy, may receive pembrolizumab for an additional 18 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Streptococcus pneumoniae type 19f capsular polysaccharide antigen

FDA approved

Pembrolizumab

FDA approved

Cryosurgery

2015

Completed Phase 4

~550

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

Dendritic cell therapy involves using a patient's own tumor cells and white blood cells to create a vaccine that stimulates the immune system to recognize and attack cancer cells. Cryosurgery kills cancer cells by freezing them, causing cell death and reducing tumor size. Pembrolizumab is a monoclonal antibody that enhances the immune response by blocking the PD-1 pathway, which tumors use to evade immune detection. These treatments are significant for NHL patients as they offer targeted approaches to boost the body's natural defenses against cancer, potentially leading to more effective and personalized treatment outcomes.