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New treatment option for Acute Myeloid Leukemia
Official title Adoptive T Cell Therapy With DC/AML Fusion Vaccine Plus Decitabine and Venetoclax in AML
ClinicalTrials.gov ID: NCT07374029
What this study is testing
What is DC/AML Fusion Vaccine?
DC/AML Fusion Vaccine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Prior to Tumor Collection
- Patients must have AML at initial diagnosis for which decitabine/venetoclax is planned as standard of care therapy. This can include patients with...
- Patients with AML in first relapse after cytotoxic and/or targeted therapy for which decitabine and venetoclax therapy is appropriate standard of...
- ECOG performance status ≤ 2 (Appendix A)
- Participants must have normal organ and marrow function as defined below:
You likely can't join if
- Prior to Tumor Collection
- 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...
- Patients who have received a prior allogeneic transplant will be excluded.
- Because of compromised cellular immunity, patients who have active human immunodeficiency virus (HIV), untreated hepatitis C virus (HCV) or evidence...
See the full eligibility criteria
Who can join
- Prior to Tumor Collection
- 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...
- 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...
- ECOG performance status ≤ 2 (Appendix A)
- Participants must have normal organ and marrow function as defined below:
- total bilirubin≤ 2.0 mg/dL
- AST/ALT ≤ 3 × institutional upper limit of normal
- creatinine ≤ 2.0 mg/dl
- The effects of vaccine stimulated T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of...
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- Prior to Tumor Collection
- 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: people with hypothyroidism (eg, following Hashimoto syndrome) stable on...
- Patients who have received a prior allogeneic transplant will be excluded.
- Because of compromised cellular immunity, patients who have active human immunodeficiency virus (HIV), untreated hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
- Patients must not have active significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia.
- Patients must not be pregnant. All premenopausal patients will undergo pregnancy testing. Men will agree to not father a child while on protocol treatment. Men and women will practice effective birth control while...
- Patients must have obtained a response of PR or better to decitabine and venetoclax as defined in Section 11.
- Resolution of all HMA/venetoclax related grade III-IV toxicity as per CTC criteria 4.0, other than grade 3 anemia.
- Laboratories:
- ANC ≥ 1,000/µL
- Platelets ≥ 50,000/uL
- Bilirubin ≤ 2.0 mg/dL
- Creatinine ≤ 2.0 mg/dL
- AST/ALT ≤ 3.0 x ULN Exclusion Criteria Prior to Leukapheresis
- Patients must not have serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart...
- Patients who, with their treating physician, choose to proceed with an allogeneic transplant at the time of remission will not be eligible for leukapheresis
- Patients with active systemic autoimmune disease requiring ongoing systemic therapy are excluded. The following is an exception to this criterion: people with hypothyroidism (eg, following Hashimoto syndrome) stable on...
- Current or prior use of immunosuppressive medication within 14 days prior to first T cell infusion. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (eg...
- Known human immunodeficiency virus (HIV), untreated hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
- Female people who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control from starting treatment, including dosing interruptions through 90...
- Male people who are not employing an effective method of birth control from starting vaccine, including dosing interruptions through 90 days after receipt of the last dose of treatment. Refrain from sperm cell donation...
- Patient completed 4 cycles of decitabine and venetoclax without evidence of disease recurrence or progression
- Resolution of all chemotherapy related grade III-IV toxicity as per CTC criteria 4.0, other than grade 3 anemia, at the time of initiation of cycle 5, 6, or 7 of decitabine/venetoclax therapy.
- Laboratories:
- ANC ≥ 1,000/µL
- Platelets ≥ 50,000/uL
- Bilirubin ≤ 2.0 mg/dL
- Creatinine ≤ 2.0 mg/dL
- AST/ALT ≤ 3.0 x ULN
- Generation of adequate yield of T cells to meet dosing requirement
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.