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DC AML Vaccine for Acute Myeloid Leukemia
Phase 2
Waitlist Available
Led By Jacalyn Rosenblatt, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is investigating whether an experimental vaccine can help keep leukemia in remission. The vaccine will be given to patients who have achieved remission with chemotherapy.
Who is the study for?
This trial is for adults with Acute Myeloid Leukemia (AML) who are in remission after chemotherapy. They must have recovered from severe chemo side effects, be able to produce at least two doses of the vaccine, and not have HIV or a history of other cancers. Participants need to agree to use contraception and cannot have serious illnesses like significant heart disease or active autoimmune disorders.Check my eligibility
What is being tested?
The trial tests the safety of a Dendritic Cell AML Fusion Vaccine (DC AML vaccine), designed to help the immune system recognize and destroy leukemia cells, preventing relapse after chemotherapy. Patients receive this investigational vaccine alone as part of post-chemotherapy treatment.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to vaccines such as soreness at injection site, fever, fatigue, and allergic responses. Since it's an immunotherapy that targets cancer cells, there might also be risks associated with immune system activation.
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
Toxicity
Secondary outcome measures
Disease Response
Immune Response
T-cell and Immune Response
Trial Design
1Treatment groups
Experimental Treatment
Group I: Group 1Experimental Treatment1 Intervention
DC AML Fusion Vaccine
Find a Location
Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,273 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,525 Total Patients Enrolled
Medivation, Inc.Industry Sponsor
75 Previous Clinical Trials
11,179 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I will have tests to check for tiny amounts of cancer after vaccination.I have not had any other type of cancer, or it meets the study's specific exceptions.I will not receive the vaccine if I opt for a stem cell transplant during remission.I agree to use birth control during the study.I have acute myeloid leukemia either newly diagnosed or at first relapse.I am 18 years old or older.My cancer is in complete remission after chemotherapy, with very few cancer cells found in my bone marrow.I have recovered from severe side effects of my previous cancer treatment.I have serious heart problems like heart failure or unstable chest pain.I have an autoimmune condition, but it's not Type II diabetes, vitiligo, or stable hyperthyroidism.All my severe side effects from chemotherapy have gone away.I have received at least 2 doses of the fusion vaccine.I do not have a serious illness like a major infection or heart disease.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
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.
Is recruitment for this research still ongoing?
"Clinicaltrials.gov displays that, while this clinical trial was initially published on May 1st 2010 and last modified in January 25th 2022, it is not presently enrolling patients. However, there are 820 other trials currently searching for individuals to participate."
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