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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
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 moreOther 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
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,142 Total Patients Enrolled
1,381 Trials studying Lymphoma
382,389 Patients Enrolled for Lymphoma
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,773 Total Patients Enrolled
62 Trials studying Lymphoma
27,932 Patients Enrolled for Lymphoma
Yi LinPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
13 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any experimental drugs for my cancer in the last 28 days or within 4 half-lives of the drug.My follicular lymphoma has become resistant to treatment after transforming.I have an active brain or spinal cord tumor.I have a lung condition not caused by an infection.My biopsy confirms I have non-Hodgkin lymphoma, but not CLL, CNS lymphoma, or Burkitt's.I am fully active or can carry out light work.I have not received a live vaccine in the last 30 days.My aggressive NHL did not respond well to my last chemotherapy or came back within a year after my stem cell transplant.I have aggressive non-Hodgkin lymphoma and cannot or have not undergone a stem cell transplant.I have at least 3 tumors, with one larger than 2 cm, suitable for freezing and vaccine treatment.I haven't had any cancer treatments except for minor skin cancers or in situ cervical cancer in the last 6 months.I haven't had chemotherapy or radiation in the last 2 weeks and have recovered from side effects.I have an autoimmune disease like Crohn's or lupus and needed treatment recently or have a hard-to-control history.I have a slow-growing type of non-Hodgkin lymphoma and have been treated with a rituximab-based therapy.I have aggressive non-Hodgkin lymphoma and have undergone at least 2 treatment regimens.I have aggressive NHL and have been treated with an anti-CD20 drug, unless my tumor doesn't have CD20.I have severe heart issues or had a recent heart attack or unstable chest pain.I am 18 years old or older.I am currently breastfeeding.I have not had major surgery within the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, dendritic cell therapy, cryosurgery)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study open to new participants?
"The information accessible on clinicaltrials.gov states that this trial is no longer searching for participating patients, as the last update to its page took place on August 9th 2022. Although recruitment has ended, 3813 other trials are still actively looking for volunteers at present time."
Answered by AI
How many individuals have been enrolled in this research endeavor?
"This research trial is no longer seeking patients. It was posted on March 27th 2017 and edited for the final time on August 9th 2022. If you are hoping to join a clinical study, there are currently 2832 trials recruiting those with relapse, plus an additional 981 studies enrolling people who would like to receive Pneumococcal 13-valent Conjugate Vaccine."
Answered by AI
How have past research endeavors explored the efficacy of Pneumococcal 13-valent Conjugate Vaccine?
"Currently, there are 981 active trials for the Pneumococcal 13-valent Conjugate Vaccine with 127 of these studies in Phase 3. Although Houston, Texas is the most popular location to conduct research on this vaccine, over 36 thousand medical centers across the world are carrying out relevant experiments."
Answered by AI
What is the typical indication for Pneumococcal 13-valent Conjugate Vaccine?
"The Pneumococcal 13-valent Conjugate Vaccine is normally prescribed to those with inoperable melanoma, as well as to individuals who have a heightened chance of recurrence or are afflicted by microsatellite instability."
Answered by AI
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