Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults
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|ClinicalTrials.gov Identifier: NCT04249830|
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : January 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hematologic Diseases||Biological: Allogeneic Stem Cell Transplant Device: CliniMACS TCR α/β Reagent Kit and CliniMACS CD19||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogeneic Hematopoietic Stem Cell Transplantation From an HLA-partially Matched Related or Unrelated Donor After TCR αβ+T Cells/CD19+ B Cell Depletion in Children and Young Adults Affected by Malignant or Non-Malignant Hematological Disorders|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||February 2025|
|Estimated Study Completion Date :||February 2025|
Experimental: Stem Cell Transplant
The participant will undergo a stem cell transplant using donor cells that have been manipulated through an investigational device. Participants will be followed for outcomes for two years.
Biological: Allogeneic Stem Cell Transplant
The allogeneic stem cell transplant involves transferring the stem cells from a healthy person (donor) to the participant via infusion.
Device: CliniMACS TCR α/β Reagent Kit and CliniMACS CD19
The CliniMACS™system can be used to selectively enrich or reduce specific cell populations based on the magnetic cell selection (MACS) technology developed by Miltenyi Biotec. Cell mixtures can be separated in a magnetic field using one or more immunomagnetic- labeled antibodies specific for the cell types of interest (e.g.TCR αβ+ T cells and CD19+ B cells from HPC(A) products).
- Number of participants with successful engraftment at day 42 after HSCT [ Time Frame: Day 42 after HSCT ]
- Number of participants with grade II-IV acute GvHD at day 100 after HSCT [ Time Frame: Through Day 100 after HSCT ]
- Number of participants with grade III-IV acute GvHD at day 100 after HSCT [ Time Frame: Through Day 100 after HSCT ]
- Number of participants with chronic GVHD at 1 year after HSCT [ Time Frame: 1 year after HSCT ]
- Leukemia-free survival at 1 year after HSCT [ Time Frame: 1 year after HSCT ]Leukemia-free survival defined as the time of enrollment to disease relapse or death from any cause.
- Leukemia-free survival at 2 years after HSCT [ Time Frame: 2 years after HSCT ]Leukemia-free survival defined as the time of enrollment to disease relapse or death from any cause.
- Number of participants with secondary graft failure at 1 year after HSCT [ Time Frame: 1 year after HSCT ]
- Number of participants with secondary graft failure at 2 years after HSCT [ Time Frame: 2 years after HSCT ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04249830
|United States, California|
|Lucile Packard Children's Hospital||Recruiting|
|Palo Alto, California, United States, 94306|
|Contact: Study Team 650-497-2447 firstname.lastname@example.org|
|Sub-Investigator: David Shyr, MD|
|Sub-Investigator: Alison Holzer-Speed, PhD|
|Principal Investigator:||Alice Bertaina, MD, PhD||Associate Professor of Pediatrics, Stem Cell Transplantation|