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

Last updated: May 26, 2024
Sponsor: Sijia Gu
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bone Marrow Transplant

Anemia

Transplant Rejection

Treatment

TCRαβ Depleted haploidentical HCT

Clinical Study ID

NCT06423131
SCMCIRB-K2024030-2
  • Ages 8-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminaseshigher 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 interferewith their ability to understand the requirements of the study

  • Patients unwilling or unable to comply with the protocol or unable to give informedconsent

  • Concurrent severe or uncontrolled infection

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: TCRαβ Depleted haploidentical HCT
Phase:
Study Start date:
May 26, 2024
Estimated Completion Date:
March 31, 2028

Study 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.

Connect with a study center

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

    Shanghai, Shanghai
    China

    Active - Recruiting

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