Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults

STATUS

Recruiting
days left to enroll

69
participants needed

50
sponsor

Alice Bertaina

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Updated on 19 February 2024

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cancer

cardiovascular disease

renal function

direct bilirubin

ejection fraction

immunosuppression

hla-a

graft versus host disease

hematologic malignancy

arrhythmia

congestive heart failure

alt/ast

hla-drb1

Summary

The purpose of the CliniMACS TCR-Biotin System and CliniMACS CD19 is to improve the safety and efficacy of allogeneic HLA-partially matched related or unrelated donors HSCT when no matched donors are available, to treat malignant and nonmalignant disorders for which HSCT is the recommended best available therapy. Initially this device will be used in a single-center, open-label, single-arm, phase II clinical trial to evaluate the efficacy of haploidentical PBSC grafts depleted of TCR/+ and CD19+ cells using the CliniMACS TCR/CD19 System in children and adults with hematological and non-hematological malignancies.

Details

Condition	Blood disorder
Age	1years - 60years
Treatment	Allogeneic Stem Cell Transplant, CliniMACS TCR α/β Reagent Kit and CliniMACS CD19
Clinical Study Identifier	NCT04249830
Sponsor	Alice Bertaina
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age < 60 years and > 1 month
	Life expectancy > 10 weeks
	Patients deemed eligible for allogeneic HSCT per institutional guidelines
	Patients with life-threatening hematological malignancies and non-malignant disorders that could benfit from HSCT
	A minimum genotypic identical match of 5/10 is required
	The donor and recipient must be identical, as determined by high resolution typing, in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and HLA-DRB1
	Lansky/Karnofsky score > 50
	Signed written informed consent
	Male and female subjects of childbearing potential must agree to use an effective means of birth control to avoid pregnancy throughout the transplant procedure, while on immunosuppression, and if the subject experiences any chronic GvHD
Exclusion Criteria
	Pregnant or lactating females
	Greater than Grade II acute GvHD or severe, unmanaged chronic extensive GvHD due to a previous allograft at the time of inclusion
	Dysfunction of liver (ALT/AST > 10 times upper normal value, or direct bilirubin > 3 times upper normal value), or unmanageable dysfunction of renal function
	Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or left ventricular ejection fraction < 30%)
	Current active infectious disease (including positive HIV serology or viral RNA)
	Serious concurrent uncontrolled medical disorders
	Lack of patient's/parents'/guardian's informed consent
	Any severe concurrent disease which, in the judgement of the sponsor-investigator, would place the patient at increased risk during participation in the study

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Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults