Actively Recruiting
Adoptive T Cell Therapy With DC/AML Fusion Vaccine Plus Decitabine and Venetoclax in AML
Led by David Avigan · Updated on 2026-05-05
30
Participants Needed
1
Research Sites
241 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Adoptive T Cell Therapy With DC/AML Fusion Vaccine Plus Decitabine and Venetoclax in AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have AML at initial diagnosis with planned decitabine/venetoclax therapy, including those with IDH or FLT-3 mutations
- Patients with AML in first relapse appropriate for decitabine and venetoclax therapy
- ECOG performance status 2 or less
- Normal organ and marrow function: total bilirubin ≤ 2.0 mg/dL; AST/ALT ≤ 3 x institutional upper limit; creatinine ≤ 2.0 mg/dL
- Agreement to use adequate contraception if of child-bearing potential
- Ability to understand and sign informed consent
- Response of partial remission or better to decitabine/venetoclax prior to leukapheresis
- Resolution of grade III-IV toxicity related to HMA/venetoclax except grade 3 anemia
- Laboratory values prior to leukapheresis: ANC ≥ 1,000/µL; platelets ≥ 50,000/µL; bilirubin ≤ 2.0 mg/dL; creatinine ≤ 2.0 mg/dL; AST/ALT ≤ 3 x ULN
- Completion of 4 cycles of decitabine and venetoclax without disease progression before treatment with DC/AML primed T cells and fusion vaccine
- Generation of adequate T cell yield to meet dosing requirements
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Patients appropriate for intensive induction therapy at initial diagnosis
- Active systemic autoimmune disease requiring ongoing systemic therapy (except stable hypothyroidism or paraneoplastic autoimmune manifestations)
- Prior allogeneic transplant
- Active HIV, untreated hepatitis C, or active hepatitis B infection
- Active significant cardiac disease such as symptomatic congestive heart failure, unstable angina, or significant arrhythmia
- Pregnancy or breastfeeding; unwillingness to use effective birth control
- Serious intercurrent illness such as infection needing IV antibiotics
- Patients choosing an allogeneic transplant at remission time
- Use of immunosuppressive medication within 14 days prior to first T cell infusion, except for certain steroid uses
- Female patients not employing effective birth control from treatment start through 90 days post-treatment
- Male patients not employing effective birth control from vaccine start through 90 days post-treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
D
David Avigan, MD
CONTACT
E
Emma Logan, MSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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