Study on Using KIR-Favorable Donors for Transplants in Children with Certain Blood Cancers
Sponsor: Michael Pulsipher
ClinicalTrials ID:NCT02646839
This clinical trial is exploring a new approach to bone marrow transplants for children with specific blood cancers, using donors with favorable genetic markers to improve outcomes.
Patient Parameters
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Program Overview
This study is testing a new method of bone marrow transplantation for children with acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), and myelodysplastic syndrome (MDS). The focus is on using donors with specific genetic markers, known as KIR-favorable donors, to see if this can improve survival rates. The study will also look at how different genetic variations in these markers affect the success of the transplant.
Description
Bone marrow transplants are a common treatment for children with high-risk blood cancers like ALL and AML. However, not all children have a perfectly matched donor available. This study is looking at using partially matched family donors with specific genetic markers, called KIR-favorable donors, to see if this can lead to better outcomes.
The study will compare this approach to other methods, such as using umbilical cord blood, which is another option when a fully matched donor isn't available. Researchers will also examine how different genetic variations in these markers affect the success of the transplant.
Previous research has shown promising results using this method, with high survival rates in children who received transplants from KIR-favorable donors. This study aims to confirm these findings in a larger group of patients across multiple centers.
The study will also explore the cost-effectiveness of this approach and how it compares to other transplant methods. By understanding the role of these genetic markers, researchers hope to improve the success rates of bone marrow transplants for children with these serious conditions.
Eligibility Criteria
Inclusion Criteria
- Children with ALL, AML, or MDS who are eligible for a bone marrow transplant and agree to participate in the study.
- Children with ALL undergoing a specific type of genetic testing as part of the study.
- Children who need a specific type of cell depletion treatment will be included in a separate part of the study.
For the main part of the study:
- Children under 22 years old.
- Children with high-risk ALL in their first remission or in their second remission under certain conditions.
- Children with MDS or high-risk AML based on specific genetic factors or treatment responses.
- Children who have not had a previous bone marrow transplant.
- Children without a fully matched sibling or unrelated donor available.
- Children with a suitable family donor who is a partial match and has favorable genetic markers.
- Children in good overall health, with specific organ function levels and performance scores.
- Children or their guardians must be able to give informed consent.
- Children must have adequate lung, kidney, heart, and liver function based on medical tests.
Exclusion Criteria
- Pregnant or breastfeeding females, due to potential risks to the baby.
- Children with HIV or uncontrolled infections.
- Children with active leukemia in the central nervous system or other areas outside the bone marrow.
- Children with certain genetic disorders that have a poor prognosis.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Children's Hospital Oakland | 94609 | Oakland | California |
| Stanford University Medical Center | 94305 | Palo Alto | California |
| Rady Children's Hospital | 92123 | San Diego | California |
| University of California, San Francisco | 94143 | San Francisco | California |
| Lurie Children's Hospital | 60611 | Chicago | Illinois |
| New York Medical Center | 10595 | Valhalla | New York |
| Children's Hospital of Philadelphia | 19104 | Philadelphia | Pennsylvania |
| Vanderbilt University - Monroe Carell Jr. Children's Hospital | 37232 | Nashville | Tennessee |
| University of Utah, Primary Children's Hospital | 84112 | Salt Lake City | Utah |
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