45 Participants Needed

DC/AML Vaccine + Decitabine for AML

Recruiting at 1 trial location
JR
Overseen ByJacalyn Rosenblatt, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must not be on any non-FDA approved study agents and should not require active treatment with systemic steroids or immunosuppressive therapy for autoimmune or inflammatory disorders.

What data supports the effectiveness of the DC/AML Vaccine + Decitabine treatment for AML?

Research shows that dendritic cell vaccines, like the DC/AML vaccine, can help the immune system fight leukemia by increasing specific immune responses in patients with AML. Additionally, a study found that a similar dendritic cell vaccine was well tolerated and led to encouraging long-term survival rates in AML patients.12345

Is the DC/AML Vaccine + Decitabine treatment generally safe for humans?

Research on dendritic cell vaccines for acute myeloid leukemia (AML) shows that they are generally well tolerated, with no severe adverse side effects reported in several studies. Patients experienced mild and temporary reactions at the injection site, and the treatment was considered safe in both younger and older AML patients.13678

How is the DC/AML Vaccine + Decitabine treatment different from other treatments for AML?

The DC/AML Vaccine + Decitabine treatment is unique because it combines a dendritic cell-based vaccine, which uses the patient's own immune cells to target leukemia, with Decitabine, a drug that modifies DNA to enhance immune response. This approach aims to improve the immune system's ability to recognize and attack leukemia cells, offering a novel strategy compared to traditional chemotherapy.2391011

What is the purpose of this trial?

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

Research Team

Jacalyn M. Rosenblatt, MD - Beth Israel ...

Jacalyn Rosenblatt, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for adults over 18 with Acute Myelogenous Leukemia (AML) who've had a recent allogeneic transplant. They must be in remission, have good organ function, and not have severe ongoing graft-versus-host disease or other serious illnesses. Participants need to agree to use birth control and can't be on non-FDA approved study drugs or have autoimmune diseases needing steroids.

Inclusion Criteria

I have AML and have had cells stored for future treatment as per specific protocols.
I agree to use birth control during the study.
Donor chimerism of bone marrow >60%
See 17 more

Exclusion Criteria

My leukemia has spread to my brain or spinal cord.
Pregnant patients
Patients with a known history of HIV
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the DC/AML fusion cell vaccine and decitabine post-transplant

6 weeks
2 vaccines, 3 weeks apart, with potential for a booster

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • DC/AML Fusion Vaccine
  • Decitabine
Trial Overview The trial is testing a cancer vaccine called Dendritic Cell/AML Fusion vaccine alongside Decitabine, a chemotherapy drug. It aims to see if this combination helps AML patients stay in remission after an allogeneic transplant by boosting the body's immune response against leukemia cells.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: AML Patient who are undergoing transplantationExperimental Treatment1 Intervention
* 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
Group II: AML Patient who are undergoing allogeneic transplantationExperimental Treatment2 Interventions
* 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials
872
Recruited
12,930,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Dana-Farber Cancer Institute

Collaborator

Trials
1,128
Recruited
382,000+

Findings from Research

In a study involving 20 patients with acute myeloid leukemia (AML) in first complete remission, the autologous dendritic cell vaccine FDC101 was well tolerated, with only mild side effects, and resulted in 55% of patients remaining in remission over a 2-year period.
The five-year overall survival rate was 75%, indicating that this vaccine therapy could be a promising maintenance treatment for AML patients not eligible for stem cell transplantation, especially for older patients.
WT1 and PRAME RNA-loaded dendritic cell vaccine as maintenance therapy in de novo AML after intensive induction chemotherapy.Fløisand, Y., Remberger, M., Bigalke, I., et al.[2023]
Acute myeloid leukemic (AML) blasts can differentiate into leukemic dendritic cells, which may help present leukemic antigens and improve treatment for AML patients with minimal residual disease.
Advancements in culture methods have made it possible to use leukemic dendritic cells in clinical settings, but additional strategies are needed to enhance vaccine effectiveness and address the immune system's tolerance in patients.
Leukemia-derived dendritic cells: towards clinical vaccination protocols in acute myeloid leukemia.Houtenbos, I., Westers, TM., Ossenkoppele, GJ., et al.[2007]
Vaccination with autologous dendritic cells (DCs) derived from leukemic blasts in five AML patients was well tolerated, with no severe adverse effects reported, and resulted in stable conditions for three patients lasting 5.5 to 13 months.
The vaccination led to a significant increase in CD8+ T cells that specifically recognized a leukemia-associated antigen, indicating an enhanced immune response against AML, as evidenced by increased granzyme B release and a shift towards a type 1 T helper cell cytokine pattern.
Immunotherapy for patients with acute myeloid leukemia using autologous dendritic cells generated from leukemic blasts.Li, L., Giannopoulos, K., Reinhardt, P., et al.[2023]

References

WT1 and PRAME RNA-loaded dendritic cell vaccine as maintenance therapy in de novo AML after intensive induction chemotherapy. [2023]
Leukemia-derived dendritic cells: towards clinical vaccination protocols in acute myeloid leukemia. [2007]
Immunotherapy for patients with acute myeloid leukemia using autologous dendritic cells generated from leukemic blasts. [2023]
Dendritic cell vaccination in acute myeloid leukemia. [2021]
Fusion hybrids of dendritic cells and autologous myeloid blasts as a potential cellular vaccine for acute myeloid leukaemia. [2020]
A phase I/II feasibility vaccine study by autologous leukemic apoptotic corpse-pulsed dendritic cells for elderly AML patients. [2022]
Quantitative expression of Toll-like receptor-2, -4, and -9 in dendritic cells generated from blasts of patients with acute myeloid leukemia. [2008]
Dendritic Cells of Leukemic Origin: Specialized Antigen-Presenting Cells as Potential Treatment Tools for Patients with Myeloid Leukemia. [2021]
Conjugation of TLR7 Agonist Combined with Demethylation Treatment Improves Whole-Cell Tumor Vaccine Potency in Acute Myeloid Leukemia. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Dendritic cell vaccine therapy for acute myeloid leukemia: questions and answers. [2019]
Research progress on dendritic cell vaccines in cancer immunotherapy. [2023]
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