AzTrials
AzTrials

Acute Myelogenous LeukemiaPhase 2NCT03059485

DC/AML Fusion Cell Vaccine vs Observation in Patients Who Achieve a Chemotherapy-induced Remission

A Phase 2 study testing DC/AML Fusion Vaccine and Observation in people with Acute Myelogenous Leukemia, run by Beth Israel Deaconess Medical Center at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This research study is studying a cancer vaccine called Dendritic Cell/AML Fusion vaccine (DC/AML vaccine) as a possible treatment for Acute Myelogenous Leukemia (AML). The interventions involved in this study are: -Dendritic Cell/AML Fusion vaccine (DC/AML vaccine) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myelogenous Leukemia
What is being tested?
DC/AML Fusion Vaccine and Observation
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
4 sitesUnited States
Study dates
1 Jun 2017to 4 Jun 2027
Phase
Phase 2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have AML at initial diagnosis or at first relapse
  • Patients must be ≥ 55 years old
  • ECOG performance status ≤2 (Appendix A)
  • Patients must have normal organ and marrow function as defined below:
  • total bilirubin ≤ 2.0 mg/dL AST(SGOT)/ALT(SGPT) ≤3 × institutional upper limit of normal creatinine ≤ 2.0 mg/dl
  • 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.
Show all 13Show fewer
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patients must have obtained a complete remission with chemotherapy defined by the absence of circulating blasts, and less than 5% blasts on bone marrow examination following hematopoietic recovery
  • Patient required no more than 2 cycles of chemotherapy or 4 cycles of a hypomethylating agent (alone or in conjunction with venetoclax) to achieve remission.
  • Resolution of all chemotherapy related grade III-IV toxicity as per CTC criteria 4.0
  • Laboratories:
  • Absolute Neutrophil Count >1,000/uL Platelets > 50,000/uL Bilirubin < 2.0 mg/dL Creatinine <2.0 mg/dL AST/ALT < 3.0 x ULN
  • For patients with evidence of minimal residual disease prior to vaccination, assessment of minimal residual disease status by cytogenetics or FISH will be followed post vaccination.

Who cannot join

  • -Active or prior documented autoimmune or inflammatory disorders including but not limited to the following:
  • --GI Disorders: (including inflammatory bowel disease [eg, ulcerative colitis, Crohn's disease], diverticulitis (with the exception of a prior episode that has resolved), celiac disease, or other serious gastrointestinal chronic conditions associated with diarrhea.
  • Systemic lupus erythematosus
  • Wegener's syndrome [granulomatosis with polyangiitis]
  • Myasthenia gravis
  • Graves' disease
Show all 39Show fewer
  • Rheumatoid arthritis
  • Hypophysitis
  • Uveitis
  • The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment..
  • Because of compromised cellular immunity, patients who have a Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
  • Patients must not have 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 receiving protocol treatment.
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: non-invasive cancer (such as, any in situ cancers) and basal cell or squamous cell carcinoma of the skin.
  • Prior allogeneic transplant
  • Step 2: Eligibility Criteria Prior to Randomization
  • 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 randomization
  • Active or prior documented autoimmune or inflammatory disorders including but not limited to the following:
  • GI Disorders: (including inflammatory bowel disease [eg, ulcerative colitis, Crohn's disease], diverticulitis (with the exception of a prior episode that has resolved), celiac disease, or other serious gastrointestinal chronic conditions associated with diarrhea.
  • Systemic lupus erythematosus
  • Wegener's syndrome [granulomatosis with polyangiitis]
  • Myasthenia gravis
  • Graves' disease
  • Rheumatoid arthritis
  • Hypophysitis
  • Uveitis
  • The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment.
  • Current or prior use of immunosuppressive medication within 14 days prior to first dose of vaccine. 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), hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
  • History of hypersensitivity to durvalumab or any excipient
  • Receipt of live attenuated vaccination within 30 days prior the first vaccine
  • 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 vaccine, including dosing interruptions through 90 days after receipt of the last vaccine. Refrain from egg cell donation during vaccination and for at least 90 days after the last vaccine.
  • 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 vaccine. Refrain from sperm donation during vaccination and for at least 90 days after the last vaccine.
  • Step 3: Eligibility Criteria Prior to Treatment or Observation
  • Resolution of all chemotherapy related grade III-IV toxicity as per CTC criteria 4.0
  • Laboratories:
  • WBC > 2.0 X 103/uL Platelets > 50,000/uL Bilirubin < 2.0 mg/dL Creatinine <2.0 mg/dL AST/ALT < 3.0 x ULN
  • At least 2 doses of fusion vaccine were produced (Arm A only)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02214

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: A Randomized Phase II Clinical Trial of Dendritic Cell/AML Fusion Cell Vaccine Versus Observation in Patients Who Achieve a Chemotherapy-induced Remission

This research study is studying a cancer vaccine called Dendritic Cell/AML Fusion vaccine (DC/AML vaccine) as a possible treatment for Acute Myelogenous Leukemia (AML).

The interventions involved in this study are:

-Dendritic Cell/AML Fusion vaccine (DC/AML vaccine)

Read the detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved the DC/AML vaccine as a treatment for any disease.

The FDA (the U.S. Food and Drug Administration) has not approved durvalumab as a treatment for AML.

In this research study, the investigators are determining if the DC/AML vaccine can be used safely in subjects with acute leukemia after finishing chemotherapy, and whether the DC/AML vaccine is capable of producing immune responses against leukemia alone. Cancer cells are foreign to the body and have unique markers that distinguish them from normal cells. These markers can potentially serve as targets for the immune system. An immune response is any reaction by the immune system; a complex system that is responsible for distinguishing us from everything foreign to us, and for protecting us against infections and foreign substances.

The Dendritic Cell Fusion Vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells. Unlike a standard vaccine that is used to prevent infections, cancer vaccines are being studied to see if they can fight cancers that are already in the body. Laboratory studies have shown that when dendritic cells and tumor cells are brought together, the dendritic cells can stimulate immune responses against the tumor and, in some cases, cause the tumor to shrink.

Being tested
DC/AML Fusion Vaccine, Observation
Keywords
Leukemia
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DC/AML Fusion VaccineBiological

    The Dendritic Cell Fusion Vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells

  • ObservationOther

    Traditional care provided by the hospital.

Study groups in NCT03059485
Study groupRoleWhat they receive
DC/AML VaccineExperimental- Patients will be vaccinated with DC/AML Fusion Vaccine
Receives: Biological: DC/AML Fusion Vaccine; Other: Observation
ObservationExperimental- Patients will be monitored with routine labs and bone marrow biopsies
Receives: Other: Observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Measured: 2 years

Secondary outcomes (2)

  1. Overall Survival

    Measured: 2 years

  2. Assessing Toxicity using CTCAE version 4.03

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2017
  2. Study start1 Jun 2017
  3. Primary completion4 Dec 2026 (estimated)
  4. Study completion4 Jun 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03059485
Sponsor's protocol ID
16-593
Status last verified
Sep 2026
First submitted
15 Feb 2017
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DC/AML Fusion Vaccine and Observation in people with Acute Myelogenous Leukemia, run by Beth Israel Deaconess Medical Center at 4 sites 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 13 inclusion and 39 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03059485.

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 29 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in