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Cancer Vaccine

DC/AML Vaccine + Decitabine for AML

Phase 1
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
Patients with AML who have undergone AML cell harvest and cryopreservation as per protocol 16-593 or companion protocol 18-232 and had a minimum of 5x10^7 cells cryopreserved
No evidence of ongoing grade 2 or higher aGVHD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is studying how well the DC/AML vaccine works when given with decitabine in treating patients with AML.

Who is the study for?
This trial is for adults over 18 with Acute Myelogenous Leukemia (AML) who've had a recent allogeneic transplant. They must be in remission, have good organ function, and not have severe ongoing graft-versus-host disease or other serious illnesses. Participants need to agree to use birth control and can't be on non-FDA approved study drugs or have autoimmune diseases needing steroids.Check my eligibility
What is being tested?
The trial is testing a cancer vaccine called Dendritic Cell/AML Fusion vaccine alongside Decitabine, a chemotherapy drug. It aims to see if this combination helps AML patients stay in remission after an allogeneic transplant by boosting the body's immune response against leukemia cells.See study design
What are the potential side effects?
Potential side effects may include typical reactions from vaccines such as soreness at the injection site, fever, fatigue, and allergic responses. Decitabine can cause low blood counts leading to increased infection risk, bleeding issues, nausea, vomiting and liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have AML and have had cells stored for future treatment as per specific protocols.
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I do not have severe ongoing graft-versus-host disease.
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I am 25-45 days post-transplant from a closely matched or half-matched donor.
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My blood cancer is in complete remission with very few cancer cells in my bone marrow.
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I do not have ongoing severe graft-versus-host disease.
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I take less than 20mg of prednisone or its equivalent daily.
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I do not have any untreated or uncontrolled infections.
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I don't have severe side effects from previous treatments.
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My cancer is currently in complete remission.
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My liver, kidney functions, and blood counts are within normal ranges.
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I am taking less than 20mg of prednisone or a similar steroid.
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I have recovered from severe side effects of my transplant.
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At least 2 doses of the vaccine were made for me.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The fold-increase in AML specific T cells in the peripheral blood and bone marrow
Secondary outcome measures
Complete Remission
Complete Remission with Incomplete Count Recovery
Complete Remission with Incomplete Platelet Recovery
+4 more

Side effects data

From 2012 Phase 1 & 2 trial • 25 Patients • NCT01165996
40%
Febrile neutropenia
12%
Death
8%
Neutropenic Fever
8%
bacterial infection
4%
Tooth Extraction
4%
Urinary tract infection
4%
Sepsis
4%
Orthostasis
4%
Orthostatic Hypotension
4%
Acute Left Popliteal DVT
4%
aspiration pneumonia
4%
Dehydration
4%
fever
4%
Furuncle on left groin area
4%
Headache
4%
Hematuria
4%
Hypertension
4%
Hypotension
4%
Left Sided Chest Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I

Trial Design

2Treatment groups
Experimental Treatment
Group I: AML Patient who are undergoing transplantationExperimental Treatment1 Intervention
Patients will be vaccinated with DC/AML fusion cells Four days of GM-CSF given subcutaneously at the site of vaccination Patients will receive 2 vaccines, 3 weeks apart, with the potential for a booster vaccine
Group II: AML Patient who are undergoing allogeneic transplantationExperimental Treatment2 Interventions
Patients will be vaccinated with DC/AML fusion cells Four days of GM-CSF given subcutaneously at the site of vaccination Patients will receive 2 vaccines, 3 weeks apart, with the potential for a booster vaccine Patients will be treated with 5 days of decitabine in the post-transplant setting
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
decitabine
2007
Completed Phase 2
~860

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
837 Previous Clinical Trials
13,010,227 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,926,088 Total Patients Enrolled
Dana-Farber Cancer InstituteOTHER
1,079 Previous Clinical Trials
340,936 Total Patients Enrolled

Media Library

DC/AML Fusion Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03679650 — Phase 1
Acute Myeloid Leukemia Clinical Trial 2023: DC/AML Fusion Vaccine Highlights & Side Effects. Trial Name: NCT03679650 — Phase 1
Acute Myeloid Leukemia Research Study Groups: AML Patient who are undergoing allogeneic transplantation, AML Patient who are undergoing transplantation
DC/AML Fusion Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03679650 — Phase 1

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 vacancies in this clinical trial?

"Verified through clinicaltrials.gov, this research protocol is currently recruiting participants. The trial was initially listed on October 11th 2018 and the information has been refreshed as recently as November 30th 2022."

Answered by AI

What is the current enrollment number for this clinical trial?

"Affirmative. A check of clinicaltrials.gov reveals that this scientific trial, first posted on October 11th 2018, is currently accepting participants for a study protocol. 45 individuals need to be recruited from 2 different medical facilities."

Answered by AI

To what degree can decitabine become hazardous to an individual's health?

"Decitabine has yet to be extensively tested in clinical trials, so our team awarded it a 1 on the safety scale. As this is an early stage trial, there are limited data regarding both efficacy and safety of use."

Answered by AI

What clinical applications is decitabine customarily employed for?

"Decitabine is traditionally used to treat intermediate-2 IPSS risk category, as well as refractory anemias and anemia of high-risk IPSS."

Answered by AI

What other experiments have been conducted to explore the potential of decitabine?

"As of now, 102 clinical trials are evaluating the efficacy and safety of decitabine. Of those studies, 15 have progressed to Phase 3 testing. The majority of these experiments are located in Philadelphia; however, 1483 additional sites across the globe offer this treatment option."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dendritic Cell/AML Fusion Cell Vaccine Following Allogeneic Transplantation in AML Patients
Jacalyn Rosenblatt 2018. "Dendritic Cell/AML Fusion Cell Vaccine Following Allogeneic Transplantation in AML Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03679650.
~3 spots leftby Aug 2024
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