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Cancer Vaccine
DC/AML Fusion Vaccine for Acute Myeloid Leukemia
Phase 2
Recruiting
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
ECOG performance status ≤2 (Appendix A)
Patients must have normal organ and marrow function as defined below: total bilirubin ≤ 2.0 mg/dL AST(SGOT)/ALT(SGPT) ≤3 × institutional upper limit of normal creatinine ≤ 2.0 mg/dl
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing the safety and effectiveness of a cancer vaccine called DC/AML in people with AML.
Who is the study for?
This trial is for adults aged 55 or older with Acute Myelogenous Leukemia (AML) who are in remission after chemotherapy. They must have normal organ and marrow function, not be pregnant, agree to use contraception, and can't have autoimmune diseases or other cancers within the last 5 years (except certain skin cancers).Check my eligibility
What is being tested?
The study is testing a cancer vaccine called Dendritic Cell/AML Fusion vaccine against observation only. Participants will either receive this experimental vaccine to help prevent AML from returning or they'll be observed without receiving the vaccine.See study design
What are the potential side effects?
Potential side effects of the DC/AML Fusion Vaccine aren't detailed here but may include typical immune responses such as fever, fatigue, injection site reactions, and possibly allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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My liver and kidney functions are within normal ranges.
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My condition is either newly diagnosed AML or AML at first relapse.
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I am 55 years old or older.
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My cancer responded completely to chemotherapy, with almost no cancer cells found in my bone marrow.
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
Progression Free Survival
Secondary outcome measures
Assessing Toxicity using CTCAE version 4.03
Overall Survival
Trial Design
2Treatment groups
Experimental Treatment
Group I: ObservationExperimental Treatment1 Intervention
- Patients will be monitored with routine labs and bone marrow biopsies
Group II: DC/AML VaccineExperimental Treatment2 Interventions
- Patients will be vaccinated with DC/AML Fusion Vaccine
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
837 Previous Clinical Trials
13,010,197 Total Patients Enrolled
CelgeneIndustry Sponsor
636 Previous Clinical Trials
128,779 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,079 Previous Clinical Trials
340,905 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.I am choosing to have a stem cell transplant from a donor during my remission.All my severe side effects from chemotherapy have gone away.I can take care of myself but might not be able to do heavy physical work.I do not have serious heart problems like heart failure, chest pain, or irregular heartbeat.My liver and kidney functions are within normal ranges.I agree to use birth control or abstain from sex during the study.I am not pregnant, and I will use effective birth control during the treatment.I do not have a serious illness like a major infection or heart disease.I haven't taken strong immune-weakening medicines in the last 14 days, except for minor exceptions like skin creams or asthma inhalers.I had cancer before, but it was either non-invasive or skin cancer, or I've been cancer-free for 5 years.I do not have serious autoimmune or inflammatory conditions, except for stable thyroid issues, vitiligo, alopecia, or untreated psoriasis.I am not pregnant, breastfeeding, and if of childbearing potential, I am using effective birth control.I am a male not using birth control and will not donate sperm for 90 days after my last vaccine dose.I have received at least 2 doses of the fusion vaccine.My condition is either newly diagnosed AML or AML at first relapse.I have HIV, hepatitis C, or active hepatitis B.I am 55 years old or older.I achieved remission with up to 2 chemotherapy cycles or 4 cycles of a specific drug treatment.My cancer responded completely to chemotherapy, with almost no cancer cells found in my bone marrow.I have had a transplant from a donor.My minimal residual disease will be monitored after vaccination.
Research Study Groups:
This trial has the following groups:- Group 1: Observation
- Group 2: DC/AML 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 enrollment opportunities still available for this clinical trial?
"Affirmative. The clinical trial is actively searching for applicants to join the team, as evidenced on clinicaltrials.gov. It was first published on June 1st 2017 and most recently modified on April 14th 2022; concurrently, they are accepting 75 participants across 5 sites."
Answered by AI
What is the upper limit for participants in this clinical trial?
"This clinical trial necessitates 75 compliant participants, who can join from locales such as Massachusetts General Hospital in Madison or Dana Farber Cancer Institute in Atlanta."
Answered by AI
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