NK Cell Infusions for Acute Myeloid Leukemia
(EXCEL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing if giving special immune cells from a donor to children and young adults with high-risk AML can help their immune system fight cancer and infections better after a bone marrow transplant.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.
Is NK cell infusion safe for humans?
How does the NK cell infusion treatment for acute myeloid leukemia differ from other treatments?
NK cell infusion for acute myeloid leukemia is unique because it uses natural killer (NK) cells that are activated and expanded to target leukemia cells, offering a novel immunotherapy approach. Unlike traditional chemotherapy, this treatment leverages the body's immune system to fight cancer, potentially with fewer side effects.24567
What data supports the effectiveness of the treatment Ex-Vivo Expanded Natural Killer Cell Infusions for Acute Myeloid Leukemia?
Research shows that natural killer (NK) cells have strong antileukemia properties, and studies have demonstrated that infusing these cells can help some patients achieve remission. In one study, 4 out of 8 patients with relapsed acute myeloid leukemia achieved complete remission after receiving memory-like NK cells, indicating the potential effectiveness of NK cell infusions.45789
Who Is on the Research Team?
Michael L Pulsipher, MD
Principal Investigator
Children's Hospital Los Angeles
Are You a Good Fit for This Trial?
This trial is for children and young adults up to 25 years old with high-risk acute myeloid leukemia (AML) who are undergoing a specific bone marrow transplant. They must have certain genetic mutations or minimal residual disease, be recovering from chemotherapy, and have good performance status and organ function. Those with Fanconi Anemia, Down syndrome, active extramedullary disease, serious infections, or prior transplants cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Conditioning and Transplant
Participants undergo a myeloablative conditioning regimen with busulfan and cyclophosphamide, followed by HLA-haploidentical hematopoietic cell transplant
NK Cell Infusion
Participants receive three fixed dose infusions of ex-vivo expanded NK cells
Follow-up
Participants are monitored for safety, GVHD incidence, and immune reconstitution
What Are the Treatments Tested in This Trial?
Interventions
- Ex-Vivo Expanded Natural Killer Cell Infusions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Michael Pulsipher, MD
Lead Sponsor
Michael Pulsipher
Lead Sponsor
Children's Hospital Los Angeles
Lead Sponsor
Nationwide Children's Hospital
Collaborator
Seattle Children's Hospital
Collaborator