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Clinical Trials in China / NCT06423131
Recruiting Not applicable

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

NCT06423131 · tracked via the Priya Life Science China tracker
Sponsor
Sijia Gu
Phase
Not applicable
Started
2024-05-26
Last updated
2024-05-29

Condition(s) studied

Graft-Versus-Host DiseaseHematopoietic Stem Cell TransplantationChild, OnlyHaploidentical Hematopoietic Stem Cell Transplantation

Investigational drug(s) / intervention(s)

TCRαβ Depleted haploidentical HCT

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

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

Sex
ALL
Min age
8 Weeks
Max age
18 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of grade II-IV acute GVHD — day+100
    Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation.
  • incidence of treatment related mortality(TRM) — day +100
    compare the incidence of TRM until Day 100 post-transplantation

Trial sites (1)

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

More Sijia Gu trials in China

Shanghai Children's Health, Education and Lifestyle Evaluation, Preschool (the SCHEDULE-P Study) Recruiting

Other trials for the same condition

Population PK-guided ATG Dosing in Haplo-HSCT Recruiting
Effect of Sevoflurane on Sweat Threshold in Children of Different Ages Starting soon
Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients Recruiting
Letermovir Prophylaxis Duration Guided by CMV-Specific T-cell Monitoring After Allo-HSCT. Recruiting
Busulfan-Based Versus TBI-Based Conditioning for Adult ALL-CR2 Allo-HSCT Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06423131 on ClinicalTrials.gov ↗ ← All trials in China