Study on Memory-like NK Cell Therapy After Partial Match Donor Stem Cell Transplant
Sponsor: Washington University School of Medicine
ClinicalTrials ID:NCT02782546
This clinical trial is testing a new treatment using memory-like NK cells after a partial match stem cell transplant to improve survival rates in patients with high-risk leukemia. The study will monitor safety and stop if there are high rates of complications.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is exploring a new treatment approach for patients with high-risk leukemia who are undergoing a stem cell transplant from a partially matched donor. The treatment involves using special immune cells called memory-like NK cells to help improve survival rates. The study aims to increase the chances of being leukemia-free 100 days after the transplant from less than 10% to 30%. Safety checks will be conducted regularly, and the study will be paused if there are high rates of complications like graft failure or severe immune reactions.
Eligibility Criteria
Inclusion Criteria
- Have a type of leukemia called AML that hasn't responded to at least two rounds of treatment or has returned after treatment.
- Be 18 years or older.
- Have a partially matched donor available.
- If leukemia has spread to the brain, it must be treated and clear for at least two weeks before joining the study.
- Be in good overall health with a performance status above 60%.
- Have good organ function, including:
- Total bilirubin less than 2 mg/dl.
- Liver enzymes (AST/ALT) less than 3 times the normal limit.
- Normal kidney function or creatinine clearance above 60 mL/min.
- Oxygen levels in the blood at least 90% on room air.
- Heart's pumping ability at least 40%.
- Be able to stop taking most immune-suppressing medications before starting the study.
- Women of childbearing age must have a negative pregnancy test and agree to use two forms of birth control during the study.
- Be able to understand and sign a consent form.
Exclusion Criteria
- Have relapsed after a previous stem cell transplant.
- Have a high number of leukemia cells in the blood.
- Have uncontrolled infections or known infections like HIV or hepatitis.
- Have specific antibodies against the donor.
- Have severe heart problems or new lung issues.
- Be allergic to any study medications.
- Have taken experimental drugs recently.
- Be pregnant or breastfeeding.
Donor Inclusion Criteria:
- Be a related donor, like a sibling or child.
- Be 18 years or older.
- Be a partial match with the recipient.
- Be in good health and able to donate cells.
- Be able to understand and sign a consent form.
Donor Exclusion Criteria:
- Have infections like hepatitis or HIV.
- Be pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Washington University School of Medicine | 63110 | St Louis | Missouri |
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