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

Not Applicable

Recruiting

• Conditions: Haploidentical Hematopoietic Stem Cell Transplantation; Graft-Versus-Host Disease; Hematopoietic Stem Cell Transplantation; Child, Only
• Interventions: Procedure: TCRαβ Depleted haploidentical HCT

• Registration Number: NCT06423131
• Lead Sponsor: Sijia Gu

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-15
• Study First Submitted QC: 2024-05-15
• Study First Posted: 2024-05-21
• Study Start: 2024-05-26
• Last Update Submitted: 2024-05-26
• Last Update Posted: 2024-05-29
• Primary Completion: 2027-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCRαβ Depleted haploidentical HCT	TCRαβ Depleted haploidentical HCT	TCRαβ Depleted haploidentical HCT is experimental used to decrease GVHD and obtain better qulity of life for children with haploidentical HCT.

Primary Outcome Measures

Name	Time	Method
incidence of treatment related mortality(TRM)	day +100	compare the incidence of TRM until Day 100 post-transplantation
Incidence of grade II-IV acute GVHD	day+100	Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation.

Secondary Outcome Measures

Name	Time	Method
TRM post day +1y and +2y	day +1y and +2y	compre the incidence of TRM post HSCT day 1y and 2y
cGVHD post day 1y and 2y	day +1y and +2y	compare the incidence of cGVHD post HSCT 1y and 2y
post HSCT day 1y and 2y GRFS and OS	day +1y and +2y	compare the incidence of GRFS and OS post HSCT 1y and 2y

Trial Locations

Locations (1)

Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China