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

May 26, 2024 updated by: Sijia Gu

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Traditional Haplo identicle HCT
Beijing haploidenticla HCT is the routinely traditional way used for haploidentical HCT
Experimental: TCRαβ Depleted haploidentical HCT
TCRαβ Depleted haploidentical HCT is experimental used to decrease GVHD and obtain better qulity of life for children with haploidentical HCT.
Procedure: TCRαβ Depleted haploidentical HCT
Use the CliniMACS TCRα/β deplete from the mobilized peripheral blood stem cells of haploidentical donor in children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day+100
incidence of treatment related mortality(TRM)
Time Frame: day +100
compare the incidence of TRM until Day 100 post-transplantation
day +100

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day +1y and +2y
cGVHD post day 1y and 2y
Time Frame: day +1y and +2y
compare the incidence of cGVHD post HSCT 1y and 2y
day +1y and +2y
TRM post day +1y and +2y
Time Frame: day +1y and +2y
compre the incidence of TRM post HSCT day 1y and 2y
day +1y and +2y

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sijia Gu

Investigators

  • Principal Investigator: Jing Chen, PhD, Shanghai Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 26, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCMCIRB-K2024030-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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