## Protocol Section
### Identification Module
**NCT ID:** NCT06423131

**Brief Title:** Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT

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

#### Organization Study ID Info
**ID:** SCMCIRB-K2024030-2
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Jiao Tong University School of Medicine
### Status Module
#### Completion Date
**Date:** 2028-03-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-26

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-03-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-26

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sijia Gu

#### Responsible Party

**Investigator Affiliation:** Shanghai Jiao Tong University School of Medicine

**Investigator Full Name:** Sijia Gu

**Investigator Title:** Principal investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Graft-Versus-Host Disease

- Hematopoietic Stem Cell Transplantation

- Child, Only

- Haploidentical Hematopoietic Stem Cell Transplantation

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** TCRαβ depleted HSCT compare to traditional Beijing haploidentical HSCT

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 110

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Beijing haploidenticla HCT is the routinely traditional way used for haploidentical HCT

**Label:** Traditional Haplo identicle HCT

**Type:** NO_INTERVENTION

#### Arm Group 2

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

**Intervention Names:**

- Procedure: TCRαβ Depleted haploidentical HCT

**Label:** TCRαβ Depleted haploidentical HCT

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TCRαβ Depleted haploidentical HCT

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

**Name:** TCRαβ Depleted haploidentical HCT

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation.

**Measure:** Incidence of grade II-IV acute GVHD

**Time Frame:** day+100

**Description:** compare the incidence of TRM until Day 100 post-transplantation

**Measure:** incidence of treatment related mortality(TRM)

**Time Frame:** day +100

#### Secondary Outcomes

**Description:** compare the incidence of GRFS and OS post HSCT 1y and 2y

**Measure:** post HSCT day 1y and 2y GRFS and OS

**Time Frame:** day +1y and +2y

**Description:** compare the incidence of cGVHD post HSCT 1y and 2y

**Measure:** cGVHD post day 1y and 2y

**Time Frame:** day +1y and +2y

**Description:** compre the incidence of TRM post HSCT day 1y and 2y

**Measure:** TRM post day +1y and +2y

**Time Frame:** day +1y and +2y

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 18 Years

**Minimum Age:** 8 Weeks

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** chenjing@scmc.com.cn

**Name:** Jing Chen, PhD

**Phone:** 38626161

**Phone Ext:** 82073

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** chenjing@scmc.com.cn

- **Name:** J Chen, PhD

- **Phone:** 38626161

- **Phone Ext:** 82073

- **Role:** CONTACT

**Country:** China

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

**State:** Shanghai

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Shanghai Children's Medical Center

**Name:** Jing Chen, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9189

- Name: Graft vs Host Disease

- Relevance: HIGH

- As Found: Graft Versus Host Disease

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T2832

- Name: Homologous Wasting Disease

- Relevance: HIGH

- As Found: Graft Versus Host Disease

### Condition Browse Module - Meshes

- ID: D000006086

- Term: Graft vs Host Disease

### Misc Info Module

- Version Holder: 2024-05-31
