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Cancer Vaccine
Lymphoma Vaccine for Follicular Lymphoma
Phase 1
Waitlist Available
Led By Eric Jacobsen, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
35 years of age or older
Histologically confirmed follicular lymphoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new lymphoma vaccine to see if it is safe and if it boosts the immune system to better fight the cancer.
Who is the study for?
This trial is for adults over 35 with follicular lymphoma who've had a stem cell transplant at least 6 months ago and responded to recent treatment. They must have a sample of their tumor available, be in good physical condition (ECOG 0 or 1), and not be pregnant or nursing. People with uncontrolled infections, certain psychiatric conditions, HIV/hepatitis, autoimmune diseases requiring treatment, another cancer type, or those who've been in other vaccine trials can't join.Check my eligibility
What is being tested?
The study tests three doses of a personalized cancer vaccine made from the patient's own lymphoma cells modified to produce GM-CSF—a hormone that boosts immune response—against the participant's lymphoma. The goal is to see if this vaccine can enhance the body's natural defense against cancer.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site due to vaccination and immune system responses such as fever or fatigue. Since it involves stimulating the immune system, there might also be risks of inflammation or autoimmunity where the body attacks its own cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 35 years old or older.
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My lymphoma is confirmed to be of the follicular type.
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My follicular lymphoma improved after my last treatment.
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My lymphoma can be or has been sampled for vaccine preparation.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the safety and toxicity of administering vaccine composed of lethally irradiated lymphoma cells admixed with GM-CSF secreting K562 cells in patients with follicular lymphoma.
Secondary outcome measures
To describe the biologic activity of the study vaccine
to determine progression free survival and overall survival.
to determine tumor overall response rate as well as complete and partial response rates
Trial Design
1Treatment groups
Experimental Treatment
Group I: Biological/VaccineExperimental Treatment1 Intervention
Biological/Vaccine: Lethally Irradiated Lymphoma cells with GM-CSF K562 Cells Dose will vary depending upon number of cells collected and when the participant is enrolled on the study: the vaccine is given as an injection under the skin once weekly for 3 weeks then every other week for 3 vaccines.
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,908 Total Patients Enrolled
Eric Jacobsen, MDPrincipal InvestigatorDana-Farber Cancer Institute
5 Previous Clinical Trials
113 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any uncontrolled infections or serious illnesses.I am 35 years old or older.I have recovered from side effects of previous treatments.It has been over 6 months since my stem cell transplant.I have another type of cancer besides the one being treated.I have had a stem cell transplant from a donor.I am on medication for an autoimmune disease.It's been over 4 weeks since my last cancer treatment.I have an autoimmune condition that affects my blood cells.My lymphoma is grade 3 or has transformed from a less aggressive form.My follicular lymphoma improved after my last treatment.My lymphoma can be or has been sampled for vaccine preparation.I am fully active or can carry out light work.My lymphoma is confirmed to be of the follicular type.
Research Study Groups:
This trial has the following groups:- Group 1: Biological/Vaccine
Awards:
This trial has 1 awards, including:- 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.
Are there any remaining spots available in this scientific trial?
"According to clinicaltrials.gov, this study has concluded its patient recruitment phase and is not currently looking for candidates. This trial was initially posted on June 1st 2007, with the last update occurring February 28th 2022. Nevertheless, there are still 1720 other trials actively recruiting patients at present."
Answered by AI
Is the use of lethally irradiated lymphoma cells with GM-CSF K562 Cells approved by the FDA?
"Given the limited data that is available on lethally irradiated lymphoma cells with GM-CSF K562 Cells, it received a score of 1 in terms of safety."
Answered by AI
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