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

NCT ID: NCT06423131

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-26

Study Completion Date

2028-03-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

TCRαβ depleted HSCT compare to traditional Beijing haploidentical HSCT
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traditional Haplo identicle HCT

Beijing haploidenticla HCT is the routinely traditional way used for haploidentical HCT

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

TCRαβ Depleted haploidentical HCT

Intervention Type PROCEDURE

Use the CliniMACS TCRα/β deplete from the mobilized peripheral blood stem cells of haploidentical donor in children

Interventions

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TCRαβ Depleted haploidentical HCT

Use the CliniMACS TCRα/β deplete from the mobilized peripheral blood stem cells of haploidentical donor in children

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

8 Weeks

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sijia Gu

OTHER

Sponsor Role lead

Responsible Party

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Sijia Gu

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jing Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Children's Medical Center

Locations

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Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Chen, PhD

Role: CONTACT

38626161 ext. 82073

Facility Contacts

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J Chen, PhD

Role: primary

38626161 ext. 82073

Other Identifiers

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SCMCIRB-K2024030-2

Identifier Type: -

Identifier Source: org_study_id

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