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

• 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

Primary Outcome Measures

Name	Time	Method
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.
incidence of treatment related mortality(TRM)	day +100	compare the incidence of TRM until Day 100 post-transplantation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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