Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TCRαβ Depleted haploidentical HCT.
- Who it may be relevant to
- Registry conditions: Graft-Versus-Host Disease, Hematopoietic Stem Cell Transplantation, Child, Only, Haploidentical Hematopoietic Stem Cell Transplantation. Basic parameters: 8 Weeks — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
TCRαβ+ Cell Deleted Versus Traditional Haploidentical Hematopoietic Stem Cell Transplantation ：A Single-center, Prospective, Non-randomized Controlled Clinical Study
Overview
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.
Interventions
- Procedure TCRαβ Depleted haploidentical HCT
Use the CliniMACS TCRα/β deplete from the mobilized peripheral blood stem cells of haploidentical donor in children
Primary outcome measures
- Incidence of grade II-IV acute GVHD [Time frame: day+100]
- incidence of treatment related mortality(TRM) [Time frame: day +100]
Secondary outcome measures (3)
- post HSCT day 1y and 2y GRFS and OS [Time frame: day +1y and +2y]
- cGVHD post day 1y and 2y [Time frame: day +1y and +2y]
- TRM post day +1y and +2y [Time frame: day +1y and +2y]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University — Shanghai
Identifiers
NCT: NCT06423131 · SCMCIRB-K2024030-2