Study on Memory-like NK Cell Therapy After Partial Match Donor Stem Cell Transplant

Sponsor: Washington University School of Medicine

Sponsor score: 40

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

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

FACILITYZIPCITYSTATE
Washington University School of Medicine63110St LouisMissouri

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