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

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:

TCRαβ+ Cell Deleted Versus Traditional Haploidentical Hematopoietic Stem Cell Transplantation ：A Single-center, Prospective, Non-randomized Controlled Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06423131
• Other study ID #: SCMCIRB-K2024030-2
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2024
• Est. completion date: March 31, 2028

Study information

• Verified date: May 2024
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Jing Chen, PhD
• Phone: 38626161
• Email: chenjing[@]scmc.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: March 31, 2028
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Weeks to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Child, Only
• Graft vs Host Disease
• Graft-Versus-Host Disease
• Haploidentical Hematopoietic Stem Cell Transplantation
• Hematopoietic Stem Cell Transplantation

Intervention

Procedure:
• TCRaß Depleted haploidentical HCT
Use the CliniMACS TCRa/ß deplete from the mobilized peripheral blood stem cells of haploidentical donor in children

Locations

Country	Name	City	State
China	Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sijia Gu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of grade II-IV acute GVHD	Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation.	day+100
Primary	incidence of treatment related mortality(TRM)	compare the incidence of TRM until Day 100 post-transplantation	day +100
Secondary	post HSCT day 1y and 2y GRFS and OS	compare the incidence of GRFS and OS post HSCT 1y and 2y	day +1y and +2y
Secondary	cGVHD post day 1y and 2y	compare the incidence of cGVHD post HSCT 1y and 2y	day +1y and +2y
Secondary	TRM post day +1y and +2y	compre the incidence of TRM post HSCT day 1y and 2y	day +1y and +2y