Adoptive T Cell Therapy With DC/AML Fusion Vaccine Plus Decitabine and Venetoclax in AML
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorDavid Avigan
About 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)
Eligibility criteria
Qualifiers
Patients must have AML at initial diagnosis for which decitabine/venetoclax is planned as standard of care therapy. This can include patients with IDH or FLT-3 mutations for whom the addition of targeted therapy agents directed at IDH or FLT-3 mutations to the decitabine/venetoclax regimen is preferred per the treating physician.
Patients with AML in first relapse after cytotoxic and/or targeted therapy for which decitabine and venetoclax therapy is appropriate standard of care. This can include patients with IDH or FLT-3 mutations for whom the addition of targeted therapy agents directed at IDH or FLT-3 mutations to the decitabine/venetoclax regimen is preferred per the treating physician.
ECOG performance status ≤ 2 (Appendix A)
total bilirubin≤ 2.0 mg/dL
Disqualifiers
Patients diagnosed with acute promyelocytic leukemia
Patients treated at initial diagnosis who are appropriate for intensive induction therapy.
Patients with active systemic autoimmune disease requiring ongoing systemic therapy are excluded. The following is an exception to this criterion: subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement. Patients with paraneoplastic auto-immune manifestations related to AML are allowed.
Patients who have received a prior allogeneic transplant will be excluded.
Trial design
Treatments tested in this trial
- DC/AML Fusion Vaccine
- T-Cell Therapy
- Decitabine
- Venetoclax
- GM-CSF
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
David Avigan
Lead sponsor
Beth Israel Deaconess Medical Center
Sponsor institution
Source ClinicalTrials.gov