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

NCT06423131 | Recruiting

• 1 other identifier: SCMCIRB-K2024030-2
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• incidence of treatment related mortality(TRM)

  compare the incidence of TRM until Day 100 post-transplantation

  day +100

Secondary Outcomes (3)

• post HSCT day 1y and 2y GRFS and OS

  day +1y and +2y

• cGVHD post day 1y and 2y

  day +1y and +2y

• TRM post day +1y and +2y

  day +1y and +2y

Study Arms (2)

Traditional Haplo identicle HCT

NO INTERVENTION

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

TCRαβ Depleted haploidentical HCT

EXPERIMENTAL

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

Procedure: TCRαβ Depleted haploidentical HCT

Interventions

TCRαβ Depleted haploidentical HCT PROCEDURE

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

TCRαβ Depleted haploidentical HCT

Eligibility Criteria

• Age: 8 Weeks - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sijia Gu: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Jing Chen, PhD

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Chen, PhD

CONTACT

38626161; chenjing@scmc.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: TCRαβ depleted HSCT compare to traditional Beijing haploidentical HSCT

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 21, 2024
• Study Start: May 26, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)