This study looks at how well removing certain T cells from donor stem cells helps prevent a condition called graft-versus-host disease in young people with blood cancers. Graft-versus-host disease happens when transplanted cells attack the body’s normal tissues. By taking out naive T cells before the transplant, doctors hope to stop this from occurring.
This is a Phase 2 trial, which means it is looking at how well the treatment works and how safe it is. The trial is FDA-regulated, and it hopes to include about 68 participants.
Who can join
The trial is open to children and young adults aged 6 months to 26 years. They must have specific types of blood cancers and be suitable for a stem cell transplant. Both boys and girls can join, and there may also be healthy volunteers. The trial team will check if each person meets the eligibility requirements.
Conditions
Acute Biphenotypic Leukemia, Acute Leukemia, Acute Leukemia of Ambiguous Lineage, Acute Lymphoblastic Leukemia, Acute Undifferentiated Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Blastic Plasmacytoid Dendritic Cell Neoplasm, Blasts Under 25 Percent of Bone Marrow Nucleated Cells, Blasts Under 5 Percent of Bone Marrow Nucleated Cells, Mixed Phenotype Acute Leukemia, Myelodysplastic Syndrome With Excess Blasts-1, Myelodysplastic Syndrome/Acute Myeloid Leukemia, Burkitt Leukemia, Chronic Monocytic Leukemia, Lymphoblastic Lymphoma, Mast Cell Leukemia, Myeloproliferative Neoplasm
Age group
Child, Adult
Sex
All sexes
The study team makes the final call on eligibility.
What happens in the study
Participants will be randomly assigned to one of two groups. Everyone will receive a type of chemotherapy before the transplant. One group will get stem cells with naive T cells removed, while the other group will receive regular stem cells. Participants will also receive medications to help prevent graft-versus-host disease and undergo various health checks throughout the study.
Where
This trial is running at 10 locations in the United States. 6 of them are currently recruiting.
Children's Hospital of Los Angeles
Los Angeles, California
Recruiting
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania
Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio
Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington
Recruiting
Oregon Health and Science University
Portland, Oregon
Recruiting
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa
Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia
Not Yet Recruiting
Dana Farber / Boston Children's Hospital
Boston, Massachusetts
Not Yet Recruiting
The first 8 of 10 sites are listed here. The registry record has the full list.