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Acute Myelogenous LeukemiaPhase 1NCT03679650

Dendritic Cell/AML Fusion Cell Vaccine Following Allogeneic Transplantation in AML Patients

A Phase 1 study testing DC/AML fusion cells in people with Acute Myelogenous Leukemia, run by Beth Israel Deaconess Medical Center at 2 sites in United States.

Active, not recruiting

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

Official record

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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) Decitabine, a chemotherapy drug 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 cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesUnited States
Study dates
11 Oct 2018to 31 Dec 2026
Phase
Phase 1

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 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
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  • 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

Who cannot join

  • 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:
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: A Phase I Clinical Trial of Dendritic Cell/AML Fusion Cell Vaccine Alone and in Conjunction With Decitabine Following Allogeneic Transplantation in AML Patients

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)
  • Decitabine, a chemotherapy drug
Read the detailed description

This research study is a Phase I clinical trial, which tests the safety of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. This study is investigating the DC/AML vaccine with and without the drug decitabine as a possible treatment for AML in the post-transplant setting.

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

The FDA has approved decitabine as a treatment option for this disease.

The FDA has not approved the combination of the DC/AML vaccine with decitabine as a treatment option for any disease,

In this research study, the investigators are determining if the DC/AML vaccine can be used safely in subjects with acute leukemia after they have undergone a transplant, and whether the DC/AML vaccine alone is capable of producing immune responses against leukemia. 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 DC/AML 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.

Decitabine is thought to act as an anti-metabolite. It seems to work by having a toxic effect on the abnormal bone marrow cells. It also appears to affect the DNA in genes that control cell growth. This promotes normal specialization and blood cell growth, so that the body is better able to make red blood cells, white blood cells, and platelets.

Being tested
DC/AML fusion cells
Keywords
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 cellsBiological

    An investigational agent that tries to help the immune system to recognize and fight against cancer cells

Study groups in NCT03679650
Study groupRoleWhat they receive
AML Patient who are undergoing allogeneic transplantationExperimental* Patients will be vaccinated with DC/AML fusion cells * Four days of GM-CSF given subcutaneously at the site of vaccination * Patients will receive 2 vaccines, 3 weeks apart, with the potential for a booster vaccine * Patients will be treated with 5 days of decitabine in the post-transplant setting
Receives: Biological: DC/AML fusion cells
AML Patient who are undergoing transplantationExperimental* Patients will be vaccinated with DC/AML fusion cells * Four days of GM-CSF given subcutaneously at the site of vaccination * Patients will receive 2 vaccines, 3 weeks apart, with the potential for a booster vaccine
Receives: Biological: DC/AML fusion cells

What is being measured

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

  1. The fold-increase in AML specific T cells in peripheral blood and bone marrow

    The fold-increase in AML specific T cells in the peripheral blood and bone marrow

    Measured: 12 months

Secondary outcomes (7)

  1. Complete Remission

    Patients in complete remission

    Measured: 12 months

  2. Complete Remission with Incomplete Count Recovery

    Patients in complete remission with incomplete count recovery

    Measured: 12 Months

  3. Complete Remission with Incomplete Platelet Recovery

    Patients in complete remission with incomplete platelet recovery

    Measured: 12 months

  4. Partial Remission (PR)

    Patients in Partial Remission

    Measured: 12 months

  5. Rate of Relapse

    Rate of relapse seen in patients

    Measured: 12 months

  6. Stable Disease

    Patients with stable disease

    Measured: 12 Months

  7. Relapse free survival

    Patients with relapse free survival

    Measured: 12 Months

Timeline

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

  1. First posted20 Sep 2018
  2. Study start11 Oct 2018
  3. Primary completion31 Mar 2026
  4. Study completion31 Dec 2026 (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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03679650
Sponsor's protocol ID
18-202
Other IDs
1P50CA206963-01A1
Status last verified
Sep 2026
First submitted
17 Sep 2018
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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