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

Sijia Gu110 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

110

Conditions

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

Interventions

TCRαβ Depleted haploidentical HCTPROCEDURE

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

Eligibility

Sex: ALLMin age: 8 WeeksMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Incidence of grade II-IV acute GVHD

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

Time frame: day+100

incidence of treatment related mortality(TRM)

compare the incidence of TRM until Day 100 post-transplantation

Time frame: day +100

Secondary Outcomes

post HSCT day 1y and 2y GRFS and OS

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

Time frame: day +1y and +2y

cGVHD post day 1y and 2y

compare the incidence of cGVHD post HSCT 1y and 2y

Time frame: day +1y and +2y

TRM post day +1y and +2y

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

Time frame: day +1y and +2y

Central Contacts

Jing Chen, PhD

CONTACT

38626161 chenjing@scmc.com.cn

Data from ClinicalTrials.gov

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