Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT

Sijia Gu

Status

Enrolling

Conditions

Child, Only

Graft-Versus-Host Disease

Haploidentical Hematopoietic Stem Cell Transplantation

Hematopoietic Stem Cell Transplantation

Treatments

Procedure: TCRαβ Depleted haploidentical HCT

Study type

Interventional

Funder types

Other

Identifiers

NCT06423131

SCMCIRB-K2024030-2

Details and patient eligibility

About

This is a single-center prospective, non-randomized controlled clinical study in China using CliniMACS TCRα/β+ cell depleted stem cell haploidentical donors versus conventional Beijing protocol for haploidentical hematopoietic stem cell transplantation in children.

Full description

1:1 non-randomized controlled clinical study in single center using CliniMACS TCRα/β+ cell depleted stem cell versus conventional Beijing protocol for haploidentical hematopoietic stem cell transplant. The purpose of this study is to obtain 30% decrease grade II-IV aGVHD and better qulity of life for TCRα/β+ cell depleted haploidentical stem cell transplantaion.

Enrollment

110 estimated patients

Sex

All

Ages

8 weeks to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 8 weeks to 18 years
Children who meet the indicators haploidentical hematopoietic cell transplantation
No HLA ≥ 9/10 donor or not suitable for this type of donor due to illness
Informed consent must be signed (by the patient or legal representative)

Exclusion criteria

Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher than 400 U/L
Chronic active viral hepatitis
Ejection fraction <50%
Respiratory failure necessitating supplemental oxygen
Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study
Patients unwilling or unable to comply with the protocol or unable to give informed consent
Concurrent severe or uncontrolled infection