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Monoclonal Antibodies
Rituximab + Vaccine Therapy + GM-CSF for Lymphoma
Phase 2
Waitlist Available
Research Sponsored by Favrille
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tumor must be accessible to biopsy or biopsy material available for preparation of autologous immunoglobulin idiotype-KLH conjugate vaccine (FavId™)
Histologically confirmed indolent B-cell non-Hodgkin's lymphoma of Grade 1 or 2 follicular lymphoma subtype
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying giving rituximab together with vaccine therapy and GM-CSF to see how well it works in treating patients with indolent B-cell non-Hodgkin's lymphoma.
Who is the study for?
This trial is for patients with a slow-growing type of blood cancer called indolent B-cell non-Hodgkin's lymphoma, specifically grade 1 or 2 follicular lymphoma. Participants need to have measurable disease after a node biopsy and accessible tumor tissue for vaccine preparation. It excludes those with other subtypes like mantle cell or CNS involvement.Check my eligibility
What is being tested?
The study tests the combination of rituximab (a monoclonal antibody), a personalized cancer vaccine made from the patient's own cells, and GM-CSF, which boosts immune cells. The goal is to see if this trio is more effective in killing cancer cells in patients with certain types of non-Hodgkin's lymphoma.See study design
What are the potential side effects?
Rituximab may cause infusion reactions, infections due to low white blood cell counts, fatigue, and body aches. Vaccines could lead to injection site reactions and flu-like symptoms. GM-CSF can result in bone pain and swelling at the injection site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor can be biopsied or there's biopsy material available for a specific vaccine preparation.
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My lymphoma is a low-grade type known as Grade 1 or 2 follicular.
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I am able to get out of my bed or chair and move around.
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I have not had any other cancer in the last 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free survival by Kaplan-Meier
Secondary outcome measures
Duration of response
Immune response by cellular or humoral anti-idiotype response positive
Overall response rate (partial and complete response) at month 6 and any time
+2 moreFind a Location
Who is running the clinical trial?
FavrilleLead Sponsor
5 Previous Clinical Trials
830 Total Patients Enrolled
5 Trials studying Lymphoma
830 Patients Enrolled for Lymphoma
John F. Bender, PharmDStudy ChairFavrille
3 Previous Clinical Trials
718 Total Patients Enrolled
3 Trials studying Lymphoma
718 Patients Enrolled for Lymphoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will use birth control during and for 30 days after the study.I have had radiation therapy before.My lymphoma has not spread to my brain or spinal cord.My tumor can be biopsied or there's biopsy material available for a specific vaccine preparation.My lymphoma is not of a specific type (mantle cell, marginal zone, MALT-type, small lymphocytic, or grade 3 follicular).I have not received any cancer treatments before.My lymphoma is a low-grade type known as Grade 1 or 2 follicular.I am able to get out of my bed or chair and move around.I have not had any other cancer in the last 5 years.I don't have any health or mental conditions that would stop me from following the study's requirements.
Research Study Groups:
This trial has the following groups: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.
Does this treatment carry any life-threatening risks for patients?
"While there is limited data supporting the efficacy of this treatment, what evidence exists points to it being a safe intervention. We've given it a score of 2."
Answered by AI
Are patients being sought for this clinical trial at present?
"Unfortunately, this particular clinical trial is not looking for patients at the moment. However, there are over 1700 other trials that might be a match for you. The original study was posted on August 1st 2004 and updated January 9th 2014 according to information found on clinicaltrials.gov"
Answered by AI
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