Pilot Study of Memory-like Natural Killer Cells After Half-Matched Family Stem Cell Transplant in High-Risk Acute Myeloid Leukemia
Sponsor: Washington University School of Medicine
ClinicalTrials ID:NCT06158828
This study is testing a new approach to improve stem cell transplants for children and young adults with high-risk acute myeloid leukemia (AML). It involves using a half-matched family donor and adding special immune cells to help fight the cancer.
Patient Parameters
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Program Overview
This study aims to improve the success of stem cell transplants for children and young adults with high-risk acute myeloid leukemia (AML). Participants will receive a stem cell transplant from a half-matched family member. One week after the transplant, they will get an infusion of special immune cells called memory-like natural killer (ML NK) cells, along with a drug called interleukin-2. This approach is designed to reduce complications and enhance the effectiveness of the transplant by preventing graft-versus-host disease (GvHD) while boosting the body's ability to fight cancer.
Eligibility Criteria
Inclusion Criteria
- Have high-risk acute myeloid leukemia (AML) in complete remission or a leukemia-free state.
- Meet specific high-risk features if newly diagnosed with AML in first remission.
- Have AML in second remission or therapy-related AML in first remission.
- AML that developed from myelodysplastic syndrome (MDS).
- Previous stem cell transplant is allowed if in remission.
- Be 30 years old or younger.
- Have a performance status score above 60%.
- Have adequate organ function, including liver, kidney, heart, and lungs.
- Agree to use effective birth control during and after the study.
- Be able to understand and sign a consent form, or have a guardian who can.
- Have a family donor who is a half-match and willing to donate cells.
Exclusion Criteria
- Have active graft-versus-host disease (GvHD).
- Have another active cancer.
- Be on other experimental treatments.
- Have active disease in the central nervous system or outside the bone marrow.
- Have allergies to study drugs.
- Cannot stop medications that interfere with ML NK cells.
- Have significant antibodies against donor cells.
- Have another major health condition that prevents transplant.
- Have Fanconi Anemia or Down Syndrome.
- Have uncontrolled illness or infection.
- Be pregnant or breastfeeding.
Donor Eligibility Criteria:
- Must be at least 18 years old.
- Must be a half-match family member.
- Must meet specific health criteria.
- Must be willing to donate cells twice.
- Must not be pregnant or breastfeeding.
- Must be able to understand and sign a consent form.
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