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NCT Number: NCT06423131

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

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.

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Key information

Conditions

Graft-Versus-Host Disease Child, Only Graft vs Host Disease Haploidentical Hematopoietic Stem Cell Transplantation Hematopoietic Stem Cell Transplantation Immune System Diseases

Age range

8 week–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

J Chen, PhD

CONTACT

[email protected]

38626161 ext. 82073

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCRαβ Depleted haploidentical HCT

Procedure

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

Primary outcomes

  1. Incidence of grade II-IV acute GVHD

    Time frame: day+100

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

  2. incidence of treatment related mortality(TRM)

    Time frame: day +100

    compare the incidence of TRM until Day 100 post-transplantation

Secondary outcomes

  1. post HSCT day 1y and 2y GRFS and OS

    Time frame: day +1y and +2y

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

  2. cGVHD post day 1y and 2y

    Time frame: day +1y and +2y

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

  3. TRM post day +1y and +2y

    Time frame: day +1y and +2y

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Chen, PhD

CONTACT

[email protected]

38626161 ext. 82073

Sponsors and collaborators

Lead sponsor

Sijia Gu

Other

Registry information

Official study title

TCRαβ+ Cell Deleted Versus Traditional Haploidentical Hematopoietic Stem Cell Transplantation ：A Single-center, Prospective, Non-randomized Controlled Clinical Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 21, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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