Expanded Access Protocol Using Alpha/Beta T and CD19+ Depleted PBSC
Sponsor: Children's Hospital of Philadelphia
ClinicalTrials ID:NCT03145545
This protocol expands access to HSCT for patients lacking a fully HLA-matched sibling donor, focusing on those with serious diseases not eligible for other CHOP protocols. It utilizes CliniMACS for alpha/beta T and CD19+ cell depletion to reduce GVHD risk, leveraging CHOP's experience with mismatched donors. Stem cells are processed aseptically per SOPs.
Patient Parameters
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Program Overview
The primary objective of this protocol is to expand access for patients who lack a fully HLA (Human leukocyte antigen) matched sibling donor, and who are candidates for allogeneic hematopoietic stem cell transplant (HSCT). These patients have a serious or immediately life-threatening disease for which HSCT is indicated. These patients are not eligible for other Children's Hospital of Philadelphia Institutional Review Board (IRB) approved protocols that utilize CliniMACs technology for T depletion.
Description
Only 25-30% of patients who may benefit from HSCT have a matched related donor. An unrelated cord blood may not be available due to size or matching criteria, or if a reduced intensity regiment is recommended. The risk of severe graft vs. host disease (GVHD) and other complications is higher with unrelated donors, or partially matched related donors. At the Children's Hospital of Philadelphia (CHOP) there is extensive experience using mismatched unrelated donors or partially matched related donors with complete or partial T depletion to reduce the risk of severe GVHD.
Eligibility Criteria
Exclusion Criteria
- Uncontrolled bacterial, viral, or fungal infections
- Fully HLA matched sibling donor (fully matched related donors including siblings may be included in special circumstances)
- Donor unable to donate peripheral stem cells
- Pregnant Females
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Philadelphia | 19104 | Philadelphia | Pennsylvania |
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