Acute Myeloid LeukemiaPhase 1NCT07374029
Adoptive T Cell Therapy With DC/AML Fusion Vaccine Plus Decitabine and Venetoclax in AML
A Phase 1 study testing DC/AML Fusion Vaccine, T-Cell Therapy and Decitabine in people with Acute Myeloid Leukemia and Acute Myeloid Leukemia, in Relapse, run by David Avigan at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Myeloid Leukemia, in Relapse
- What is being tested?
- DC/AML Fusion Vaccine, T-Cell Therapy and Decitabine
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2026to 1 Oct 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
- 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
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- 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 birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
- 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
Who cannot join
- 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.
- 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.
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- 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 receiving protocol treatment.
- 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 failure
- 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: subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement. Patients with paraneoplastic auto-immune manifestations related to AML are permitted.
- 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. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10mg/day of prednisone or equivalent
- Known human immunodeficiency virus (HIV), untreated hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
- Female subjects 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 days after last dose of treatment. Refrain from egg cell donation while receiving vaccination and for at least 90 days after the last dose of treatment.
- Male subjects 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 while receiving vaccination and for at least 90 days after the last dose of treatment.
- Inclusion Criteria Prior to Treatment with DC/AML Primed T cells and DC/AML fusion vaccine
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
David Avigan, MD, 617-667-9920, davigan@bidmc.harvard.edu
David Avigan, MD
About this study
Official title: A Phase 1, First in Human Study of Adoptive T Cell Therapy With T Cells Stimulated by Dendritic Cell (DC)/Tumor Fusions in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia (AML)
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)
Read the detailed description
The study is a dose escalation phase I clinical trial to evaluate the feasibility, safety, clinical and immune effects of adoptive T cell therapy with DC/AML Primed T cells in participants with acute myeloid leukemia (AML) treated with decitabine and venetoclax.
The U.S. Food and Drug Administration (FDA) has not approved DC/AML Vaxprimed T cells as a treatment for any disease. This is the first time that DC/AML Primed T cells will be given to humans.
The U.S. Food and Drug Administration (FDA) has not approved DC/AML fusion vaccine as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has approved GM-CSF, decitabine and venetoclax as treatment options for acute myeloid leukemia (AML).
It is expected that about 30 people will take part in this research study
- Being tested
- DC/AML Fusion Vaccine, T-Cell Therapy, Decitabine, Venetoclax, GM-CSF
- Keywords
- Acute Myeloid Leukemia (AML), Newly Diagnosed Acute Myeloid Leukemia (AML), Relapsed Acute Myeloid Leukemia (AML)
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC/AML Fusion VaccineBiological
Autologous fusion vaccine of dendritic cells and AML cells, via subcutaneous injection (under the skin) per standard of care.
T-Cell TherapyBiological
Autologous adoptive T cells, via intravenous (into the vein) infusion, per protocol.
DecitabineDrug
A pyrimidine nucleoside analogue, via intravenous infusion, per standard of care.
VenetoclaxDrug
A BCL-2 inhibitor, taken orally per standard of care.
GM-CSFDrug
A Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous injection, per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Adoptive T cell therapy with DC/AML fusion vaccine, decitabine, and venetoclax | Experimental | * 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 Receives: Drug: Decitabine; Drug: Venetoclax |
| Dose-Escalation | Experimental | 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 Receives: Biological: DC/AML Fusion Vaccine; Biological: T-Cell Therapy; Drug: Decitabine; Drug: Venetoclax; Drug: GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Manufacture and Administration Rate of Vaccine-Educated T Cells
Successful manufacture and administration rate is defined as the proportion of enrolled participants for whom autologous vaccine-educated T cells are successfully manufactured and administered per protocol.
Measured: 28 weeks
Maximum Tolerated Dose (MTD) of Vaccine-Educated T Cells
The MTD is defined as the highest dose level that one or fewer participants experiences a dose-limiting toxicity (DLT) or one dose level below the maximum administered dose level where two or more participants experience a DLT.
Measured: 56 Days
Toxicity Rate of Vaccine-Educated T Cells, Including CRS, Neurotoxicity, and Infections
Toxicity rate of vaccine-educated T cells is defined as the proportion of participants who experience at least one toxicity, including cytokine release syndrome, neurotoxicity, or infections, out of all participants who receive at least one T-cell infusion.
Measured: 5 years
Secondary outcomes (4)
Relapse-Free Survival (RFS) at 1 Year Post Administration of Vaccine Educated T Cells
RFS based on Kaplan-Meier method is defined as the time from the first T-cell infusion to the first documented disease relapse or death from any cause. Participants without relapse will be censored at the last disease assessment. Relapse is defined as the reappearance of blasts in the blood, or a bone marrow aspirate and biopsy showing >5% blasts, not attributable to another cause. If there are no circulating blasts, a repeat bone marrow performed >1 week later documenting more than 5% blasts is necessary to meet criteria for relapse.
Measured: 1 year
Relapse-Free Survival (RFS) at 2 Years Post Administration of Vaccine Educated T Cells
RFS based on Kaplan-Meier method is defined as the time from the first T-cell infusion to the first documented disease relapse or death from any cause. Participants without relapse will be censored at the last disease assessment. Relapse is defined as the reappearance of blasts in the blood, or a bone marrow aspirate and biopsy showing >5% blasts, not attributable to another cause. If there are no circulating blasts, a repeat bone marrow performed >1 week later documenting more than 5% blasts is necessary to meet criteria for relapse.
Measured: 2 years
MRD Negative Conversion Rate
MRD negative conversion rate is defined as the proportion of participants who convert from MRD-positive status at baseline to MRD-negative status at a subsequent post-baseline assessment,
Measured: MRD samples are collected up to 6 months after the last cell therapy dose.
Median Overall Survival (OS)
Overall survival (OS), estimated using the Kaplan-Meier method, is defined as the time from registration to death from any cause. Participants without a death event will be censored at the last date they are known to be alive.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start12 Feb 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Avigan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Avigan, Beth Israel Deaconess Medical Center
- Investigators
- David Avigan, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374029
- Sponsor's protocol ID
- 25-593
- Status last verified
- May 2026
- First submitted
- 21 Jan 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First in Human Study of Adoptive T Cell Therapy With T Cells Stimulated by Dendritic Cell (DC)/Tumor Fusions in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT07374029
- Acronym / sponsor ID
- 25-593
- Keywords
- Acute Myeloid Leukemia (AML), Newly Diagnosed Acute Myeloid Leukemia (AML), Relapsed Acute Myeloid Leukemia (AML)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- David AviganUniversity, hospital or other
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
The study is a dose escalation phase I clinical trial to evaluate the feasibility, safety, clinical and immune effects of adoptive T cell therapy with DC/AML Primed T cells in participants with acute myeloid leukemia (AML) treated with decitabine and venetoclax.
The U.S. Food and Drug Administration (FDA) has not approved DC/AML Vaxprimed T cells as a treatment for any disease. This is the first time that DC/AML Primed T cells will be given to humans.
The U.S. Food and Drug Administration (FDA) has not approved DC/AML fusion vaccine as a treatment for any disease. The U.S. Food and Drug Administration (FDA) has approved GM-CSF, decitabine and venetoclax as treatment options for acute myeloid leukemia (AML).
It is expected that about 30 people will take part in this research study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adoptive T cell therapy with DC/AML fusion vaccine, decitabine, and venetoclax | Experimental | Drug: Decitabine, Drug: Venetoclax* 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 |
| Dose-Escalation | Experimental | Biological: DC/AML Fusion Vaccine, Biological: T-Cell Therapy, Drug: Decitabine, Drug: Venetoclax, Drug: GM-CSFA 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- 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)
- Participants must have normal organ and marrow function as defined below:
- 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 birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Key exclusion criteria (24 listed)
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DC/AML Fusion VaccineAutologous fusion vaccine of dendritic cells and AML cells, via subcutaneous injection (under the skin) per standard of care. | Biological | Dose-Escalation |
| T-Cell TherapyAutologous adoptive T cells, via intravenous (into the vein) infusion, per protocol. | Biological | Dose-Escalation |
| DecitabineA pyrimidine nucleoside analogue, via intravenous infusion, per standard of care. | Drug | Adoptive T cell therapy with DC/AML fusion vaccine, decitabine, and venetoclax, Dose-Escalation |
| VenetoclaxA BCL-2 inhibitor, taken orally per standard of care. | Drug | Adoptive T cell therapy with DC/AML fusion vaccine, decitabine, and venetoclax, Dose-Escalation |
| GM-CSFA Granulocyte-Macrophage Colony-Stimulating Factor, via subcutaneous injection, per standard of care. | Drug | Dose-Escalation |
Primary outcome
Successful Manufacture and Administration Rate of Vaccine-Educated T Cells
Time frame: 28 weeks
Successful manufacture and administration rate is defined as the proportion of enrolled participants for whom autologous vaccine-educated T cells are successfully manufactured and administered per protocol.
Maximum Tolerated Dose (MTD) of Vaccine-Educated T Cells
Time frame: 56 Days
The MTD is defined as the highest dose level that one or fewer participants experiences a dose-limiting toxicity (DLT) or one dose level below the maximum administered dose level where two or more participants experience a DLT.
Toxicity Rate of Vaccine-Educated T Cells, Including CRS, Neurotoxicity, and Infections
Time frame: 5 years
Toxicity rate of vaccine-educated T cells is defined as the proportion of participants who experience at least one toxicity, including cytokine release syndrome, neurotoxicity, or infections, out of all participants who receive at least one T-cell infusion.
4 secondary outcomes
Relapse-Free Survival (RFS) at 1 Year Post Administration of Vaccine Educated T Cells
Time frame: 1 year
Relapse-Free Survival (RFS) at 2 Years Post Administration of Vaccine Educated T Cells
Time frame: 2 years
MRD Negative Conversion Rate
Time frame: MRD samples are collected up to 6 months after the last cell therapy dose.
Median Overall Survival (OS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Avigan, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DC/AML Fusion Vaccine, T-Cell Therapy and Decitabine in people with Acute Myeloid Leukemia and Acute Myeloid Leukemia, in Relapse, run by David Avigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Avigan, MD (617-667-9920, davigan@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Manufacture and Administration Rate of Vaccine-Educated T Cells (time frame: 28 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.