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Vaccine

Combination Immunotherapy for Non-Hodgkin Lymphoma

Phase 1 & 2
Waitlist Available
Led By Yi Lin
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

Summary

This trial is studying a combination of treatments for non-Hodgkin lymphoma. Dendritic cell therapy uses a person's own tumor cells and white blood cells to create a vaccine. Cryosurgery freezes and kills cancer cells. Pembrolizumab is a monoclonal antibody that helps the body's immune system attack 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD)
Combined Modality Therapy
Secondary outcome measures
Complete response
Disease free survival rate
Duration of response
+5 more
Other outcome measures
Change in immunologic correlates
Radiologic analysis

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
Pembrolizumab
FDA approved
Streptococcus pneumoniae type 19f capsular polysaccharide antigen
FDA approved
Cryosurgery
2015
Completed Phase 4
~540

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.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,390 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,255 Previous Clinical Trials
3,835,395 Total Patients Enrolled
Yi LinPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
13 Total Patients Enrolled

Media Library

Dendritic Cell Therapy (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03035331 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Treatment (pembrolizumab, dendritic cell therapy, cryosurgery)
Non-Hodgkin's Lymphoma Clinical Trial 2023: Dendritic Cell Therapy Highlights & Side Effects. Trial Name: NCT03035331 — Phase 1 & 2
Dendritic Cell Therapy (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03035331 — Phase 1 & 2
~0 spots leftby Aug 2024