DC/AML Fusion Vaccine for Acute Myeloid Leukemia

Not currently recruiting at 3 trial locations
EK
EK
Jacalyn Rosenblatt, MD profile photo
Overseen ByJacalyn Rosenblatt, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Beth Israel Deaconess Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new cancer vaccine as a potential treatment for Acute Myelogenous Leukemia (AML), a type of blood cancer. The study tests a vaccine made from a fusion of dendritic cells and AML cells to boost the body’s immune response against the cancer. Participants will either receive the DC/AML Fusion Vaccine or undergo close monitoring with regular lab tests and bone marrow biopsies. The trial seeks individuals diagnosed with AML who have achieved remission after treatment, particularly those requiring no more than two rounds of chemotherapy. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to potential advancements in AML treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot use immunosuppressive medication within 14 days before the first vaccine dose. Some exceptions apply, like certain types of steroids.

Is there any evidence suggesting that the DC/AML Fusion Vaccine is likely to be safe for humans?

Research shows that the DC/AML Fusion Vaccine is generally safe for people with Acute Myelogenous Leukemia (AML). Studies have found that most individuals tolerate this vaccine well. In a previous study, patients experienced minor side effects, common with vaccines, such as mild reactions like fever or tiredness, but no serious side effects were reported.

For those considering joining a clinical trial, it is reassuring that early studies have not identified any major safety issues with the DC/AML Fusion Vaccine. This information can provide confidence in its safety for potential participants.12345

Why do researchers think this study treatment might be promising?

Most treatments for Acute Myeloid Leukemia (AML) involve chemotherapy and stem cell transplants, which target rapidly dividing cancer cells but can also harm healthy cells. However, the DC/AML Fusion Vaccine offers a unique approach by using a patient's own immune cells to specifically target and attack leukemia cells. This personalized vaccine combines dendritic cells (DCs) with AML cells to stimulate the immune system more effectively. Researchers are excited because this method could potentially lead to more precise and less toxic treatments compared to traditional options.

What evidence suggests that the DC/AML vaccine might be an effective treatment for AML?

Research has shown that the DC/AML Fusion Vaccine, which participants in this trial may receive, holds promise for treating Acute Myelogenous Leukemia (AML). In an earlier study, researchers successfully created the vaccine for almost all patients, demonstrating its reliable production. Another study found that this vaccine could activate the immune system, aiding the body in fighting cancer cells. Early trial results suggest that the vaccine might enhance the body's ability to attack leukemia cells. Although more research is needed, these initial findings offer hope for future AML treatment. Participants in the observation arm will undergo monitoring with routine labs and bone marrow biopsies.14678

Who Is on the Research Team?

JR

Jacalyn Rosenblatt, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 55 or older with Acute Myelogenous Leukemia (AML) who are in remission after chemotherapy. They must have normal organ and marrow function, not be pregnant, agree to use contraception, and can't have autoimmune diseases or other cancers within the last 5 years (except certain skin cancers).

Inclusion Criteria

All my severe side effects from chemotherapy have gone away.
I can take care of myself but might not be able to do heavy physical work.
My liver and kidney functions are within normal ranges.
See 10 more

Exclusion Criteria

I have not received a live vaccine in the last 30 days.
I am choosing to have a stem cell transplant from a donor during my remission.
I do not have serious heart problems like heart failure, chest pain, or irregular heartbeat.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants undergo chemotherapy to achieve remission before entering the trial

Varies

Treatment

Participants receive the DC/AML Fusion Vaccine to stimulate immune responses against leukemia

12 weeks
6 visits (in-person)

Observation

Participants are monitored with routine labs and bone marrow biopsies

12 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • DC/AML Fusion Vaccine

Trial Overview

The study is testing a cancer vaccine called Dendritic Cell/AML Fusion vaccine against observation only. Participants will either receive this experimental vaccine to help prevent AML from returning or they'll be observed without receiving the vaccine.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: ObservationExperimental Treatment1 Intervention
Group II: DC/AML VaccineExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials
872
Recruited
12,930,000+

Celgene

Industry Sponsor

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649
Recruited
130,000+
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Citations

Final Results of Phase 1 Trial of Dendritic Cell/AML Fusion ...

Fusion vaccine was successfully generated in 26 of 27 patients. One patient relapsed prior to leukapheresis, one had insufficient DCs and 6 patients did not ...

Randomized Phase II Trial of Dendritic Cell/AML Fusion Cell ...

Here we report the results of the multicenter randomized phase II clinical trial (NCT03059485) of DC/AML fusion cell vaccination in AML patients ...

Study Details | NCT03059485 | DC/AML Fusion Cell ...

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, ...

Dendritic Cell/AML Fusion Cell Vaccine in Treating ...

Giving dendritic cell/AML fusion cell vaccine may work better in treating patients with acute myeloid leukemia is capable of producing immune responses against ...

A Phase I Clinical Trial of Dendritic Cell/AML fusion ...

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

Blockade of PD-1 in Conjunction With the Dendritic Cell ...

The purpose of this research study is to determine the safety of the Dendritic Cell AML Fusion Vaccine (DC AML vaccine) after participants have achieved a ...

Final Results of Phase 1 Trial of Dendritic Cell/AML Fusion ...

We report final results of a phase 1 clinical trial (NCT03679650) evaluating the use of DC/AML fusion vaccine, in which patient-derived AML cells are fused ...

Dendritic Cells as a Therapeutic Strategy in Acute Myeloid ...

The vaccines, likewise, were safe and well tolerated by AML patients [88]. Other researchers introduced WT1 mRNA into moDCs of the 30 AML ...