Study on Donor-Derived Natural Killer Cell Infusions for Children and Young Adults with High-Risk Acute Myeloid Leukemia Undergoing Transplant
Sponsor: Michael Pulsipher
ClinicalTrials ID:NCT04836390
This clinical trial is testing whether infusions of special immune cells from a donor can help improve outcomes for children and young adults with high-risk acute myeloid leukemia (AML) who are receiving a specific type of bone marrow transplant.
Patient Parameters
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Program Overview
This study is exploring the use of donor-derived natural killer (NK) cells, which are a type of immune cell, to help children and young adults with high-risk acute myeloid leukemia (AML) who are undergoing a bone marrow transplant from a partially matched donor. The goal is to see if these NK cell infusions can help rebuild the immune system, reduce the chances of the cancer coming back, and lower the risk of infections, all without increasing the risk of a condition called graft versus host disease (GVHD).
Eligibility Criteria
Inclusion Criteria
- Age 25 years or younger.
- Diagnosed with high-risk acute myeloid leukemia (AML).
- AML in first complete remission (CR1) with certain high-risk features or in second complete remission (CR2).
- Recovery from previous chemotherapy with a specific level of white blood cells.
- Certain genetic conditions may be eligible with approval.
- Good overall health with a performance status of 70% or higher.
- Adequate kidney, liver, heart, and lung function as determined by specific medical tests.
- Ability to provide informed consent by the patient or their guardian.
Exclusion Criteria
- Active cancer outside the bone marrow.
- Serious ongoing infections that are not responding to treatment.
- Positive pregnancy test in females who can become pregnant.
- Inability to follow medical instructions or attend follow-up appointments.
- Previous bone marrow transplant from another person.
- Diagnosis of Fanconi Anemia or Down syndrome.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Phoenix Children's Hospital | 85016 | Phoenix | Arizona |
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Children's Hospital Colorado | 80045 | Aurora | Colorado |
| AdventHealth Orlando | 32803 | Orlando | Florida |
| Johns Hopkins All Children's Hospital | 33701 | St. Petersburg | Florida |
| Ann & Robert H. Lurie Children's Hospital | 60611 | Chicago | Illinois |
| Washington University, St. Louis | 63110 | St Louis | Missouri |
| New York Medical College | 10595 | Valhalla | New York |
| Cleveland Clinic Lerner College of Medicine | 44195 | Cleveland | Ohio |
| Nationwide Children's Hospital | 43205 | Columbus | Ohio |
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