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New vaccine trial aims to train immune system against leukemia after transplant

NCT ID NCT03679650

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

28 people

The number who actually took part.

Started

Oct 2018

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.