T-Cell Therapy + Vaccine + Drugs for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this research study is to test if the combination of a new T cell therapy (dendritic cell (DC) / acute myeloid leukemia (AML) primed T cells), vaccine (DC/AML fusion vaccine) and standard of care decitabine and venetoclax is feasible and safe and effective for treatment of acute myeloid leukemia (AML).
The names of the study drugs involved in this study are:
* DC/AML fusion vaccine (immune cell vaccine)
* Granulocyte-macrophage colony-stimulating factor (GM-CSF) (a type of growth factor or hormone)
* DC/AML Primed T cells (immune cells)
* Decitabine (a type of chemotherapy drug)
* Venetoclax (a type of antineoplastic agent)
Who Is on the Research Team?
David Avigan, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Are You a Good Fit for This Trial?
This trial is for adults with Acute Myeloid Leukemia (AML) at initial diagnosis or first relapse, where decitabine/venetoclax is standard care. Participants must have an ECOG performance status ≤ 2, indicating they are able to walk and care for themselves. They need normal liver function tests and creatinine ≤ 2.0 mg/dl. Women of childbearing potential and men must use contraception.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Decitabine and Venetoclax in cycles, followed by DC/AML Primed T cells and DC/AML fusion vaccine
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored every 3 months for 2 years, then yearly for 3 years
What Are the Treatments Tested in This Trial?
Interventions
- DC/AML Fusion Vaccine
- DC/AML Primed T cells
- Decitabine
- Venetoclax
Trial Overview
The study examines a new T cell therapy combined with a DC/AML fusion vaccine, GM-CSF growth factor, alongside standard chemotherapy drugs decitabine and venetoclax in treating AML. It aims to determine the safety, feasibility, and effectiveness of this combination.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
A standard 3+3 dose escalation design will be used to find the maximum tolerated dose (MTD) of T cells. If less than 1 out of 3 or less than 2 out of 6 participants experience a dose-limiting toxicity (DLT) in a given cohort then escalation will proceed to the next dosing level. If 2 out of 6 participants experience a DLT then the prior dose level will be defined as the MTD. An additional 12 participants will be treated at the MTD. -Cycles 5 - 7 (42-day cycles): * Days 1 - 5: predetermined dose of Decitabine 1x daily * Day 15: predetermined dose of DC/AML Primed T cells 1x daily * Days 1 - 14: predetermined dose of Venetoclax 1x daily * Day 29: predetermined dose of DC/AML fusion vaccine 1x daily * Day 29: predetermined dose of GM-CSF 1x daily Follow up visits monthly for 6 months Longer term follow up every 3 months for 2 years then yearly for 3 years
* Baseline visit * Cycles 1 - 2 (28-day cycles): * Days 1 - 5: predetermined dose of Decitabine 1x daily * Days 1 - 21: predetermined dose of Venetoclax 1x daily * Bone marrow biopsy and aspiration at end of Cycle 2 * Leukapheresis * Cycles 3 - 4 (28-day cycles): * Days 1 - 5: predetermined dose of Decitabine 1x daily * Days 1 - 21: predetermined dose of Venetoclax 1x daily
Find a Clinic Near You
Who Is Running the Clinical Trial?
David Avigan
Lead Sponsor
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