New vaccine trial aims to train immune system against leukemia after transplant
NCT ID NCT03679650
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a custom-made cancer vaccine (DC/AML fusion vaccine) for people with acute myeloid leukemia (AML) who have recently had a stem cell transplant. The vaccine is designed to teach the body's immune cells to recognize and attack remaining leukemia cells. Some participants also receive a low-dose chemotherapy drug (decitabine) to boost the vaccine's effect. The goal is to see if the vaccine is safe and can increase leukemia-fighting immune cells.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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28 people
The number who actually took part.
- Started
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Oct 2018
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with AML who have undergone AML cell harvest and cryopreservation as per protocol 16-593 or companion protocol 18-232. * Patients must have had a minimum of 5x107 cells cryopreserved. * Patients must be day 25-45 following allogeneic transplantation from either: * Group A: HLA 8/8 or 7/8 matched related donor or HLA 8/8 matched unrelated donor, as determined by antigen or allele level typing at HLA A,B,C, and HLA DRB1. OR * Group B: Haplo-identical donor * Patients must be ≥ 18 years old * ECOG performance status ≤2 (Appendix A) * Participants must have normal organ and marrow function as defined below: * Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease) * AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal * Creatinine ≤ 2.0 mg/dl * Absolute neutrophil count \> 1000 * Platelet count \> 50,000 * The effects of DC/AML fusion 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. * No evidence of ongoing grade 2 or higher aGVHD * Must be on prednisone \<20mg or other steroid equivalent * Donor chimerism of bone marrow \>60% * Resolution of all transplant related grade III-IV toxicity as per CTC criteria 4.0 * Complete remission defined by absence of circulating blasts and less than 5% blasts in the bone marrow * Ability to understand and the willingness to sign a written informed consent document. Eligibility Prior to Initiating Vaccination (Groups A and B) * Assessments to be done between Day 45-75 post-transplant. * At least 2 doses of fusion vaccine were produced * No ongoing grade II-IV acute GVHD * Prednisone requirement of \< 20mg a day or steroid equivalent * Participants must have normal organ and marrow function as defined below: * Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease) * AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal * Creatinine ≤ 2.0 mg/dl * Absolute neutrophil count \> 1000 * Platelet count \> 50,000 * No uncontrolled acute infection * No CTCAE grade ≥ 3 non-hematologic toxicity * No serious intercurrent illness such as active acute infection, or significant cardiac disease characterized by clinically significant arrhythmia, active ischemic coronary disease or symptomatic congestive heart failure. * Participants must be in a complete remission Pre-Treatment Criteria Prior to Decitabine (Group A Cohort 2) * Assessments to be done within 3 days prior to initiation of therapy. * Participants must have normal organ and marrow function as defined below: * Total bilirubin ≤ 2.0 mg/dL (unless patient has Gilbert's disease) * AST(SGOT)/ALT(SGPT) ≤ 3 × institutional upper limit of normal * Creatinine ≤ 2.0 mg/dl * Absolute neutrophil count \> 1000 * Platelet count \> 50,000 Exclusion Criteria: * Because of compromised cellular immunity, patients with a known history of HIV are excluded * Leukemia with active CNS involvement * 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. * Participants may not be receiving any other Non-FDA approved study agents at the start of vaccination * Uncontrolled intercurrent illness including uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements. * Autoimmune or inflammatory disorders requiring active treatment with systemic steroids or immunosuppressive therapy limited to the following: * GI Disorders: (including inflammatory bowel disease \[e.g., ulcerative colitis, Crohn's disease\] * Systemic lupus erythematosus * Wegener's syndrome \[granulomatosis with polyangiitis\] * Myasthenia gravis * Graves' disease * Rheumatoid arthritis * Hypophysitis * Uveitis
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New transplant recipe aims to tame Graft-Versus-Host disease
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- Immune cell 'Bridge' offers new hope for tough leukemia
- Cord blood transplant offers hope for young blood cancer patients