Graft-Versus-Host DiseaseNCT06423131
Prospective Clinical Trial for Children With TCRαβ Depleted vs Traditional Haplo Identicle HSCT
A study testing TCRαβ Depleted haploidentical HCT in people with Graft-Versus-Host Disease and Hematopoietic Stem Cell Transplantation, run by Sijia Gu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 weeks to 18 years
- Conditions the study is for
- Graft-Versus-Host Disease, Hematopoietic Stem Cell Transplantation, Child, Only
- What is being tested?
- TCRαβ Depleted haploidentical HCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 26 May 2024to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 weeks to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
J Chen, PhD, 38626161 ext. 82073, chenjing@scmc.com.cn
About this study
Official title: 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.
Read the 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.
- Conditions
- Graft-Versus-Host Disease, Hematopoietic Stem Cell Transplantation, Child, Only, Haploidentical Hematopoietic Stem Cell Transplantation
- Being tested
- TCRαβ Depleted haploidentical HCT
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCRαβ Depleted haploidentical HCTProcedure or surgery
Use the CliniMACS TCRα/β deplete from the mobilized peripheral blood stem cells of haploidentical donor in children
| Study group | Role | What they receive |
|---|---|---|
| Traditional Haplo identicle HCT | No intervention | Beijing haploidenticla HCT is the routinely traditional way used for haploidentical HCT |
| TCRαβ Depleted haploidentical HCT | Experimental | TCRαβ Depleted haploidentical HCT is experimental used to decrease GVHD and obtain better qulity of life for children with haploidentical HCT. Receives: Procedure: TCRαβ Depleted haploidentical HCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade II-IV acute GVHD
Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation.
Measured: day+100
incidence of treatment related mortality(TRM)
compare the incidence of TRM until Day 100 post-transplantation
Measured: day +100
Secondary outcomes (3)
post HSCT day 1y and 2y GRFS and OS
compare the incidence of GRFS and OS post HSCT 1y and 2y
Measured: day +1y and +2y
cGVHD post day 1y and 2y
compare the incidence of cGVHD post HSCT 1y and 2y
Measured: day +1y and +2y
TRM post day +1y and +2y
compre the incidence of TRM post HSCT day 1y and 2y
Measured: day +1y and +2y
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start26 May 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-Versus-Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- TCRαβ depleted HSCT compare to traditional Beijing haploidentical HSCT
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sijia Gu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sijia Gu, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jing Chen, PhD, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423131
- Sponsor's protocol ID
- SCMCIRB-K2024030-2
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TCRαβ+ Cell Deleted Versus Traditional Haploidentical Hematopoietic Stem Cell Transplantation ：A Single-center, Prospective, Non-randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06423131
- Acronym / sponsor ID
- SCMCIRB-K2024030-2
- Conditions
- Graft-Versus-Host Disease, Hematopoietic Stem Cell Transplantation, Child, Only, Haploidentical Hematopoietic Stem Cell Transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Sijia GuUniversity, hospital or other
- Study start
- 26 May 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 21 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- TCRαβ depleted HSCT compare to traditional Beijing haploidentical HSCT
| Arm | Type | Receives |
|---|---|---|
| Traditional Haplo identicle HCT | No intervention | –Beijing haploidenticla HCT is the routinely traditional way used for haploidentical HCT |
| TCRαβ Depleted haploidentical HCT | Experimental | Procedure: TCRαβ Depleted haploidentical HCTTCRαβ Depleted haploidentical HCT is experimental used to decrease GVHD and obtain better qulity of life for children with haploidentical HCT. |
Who may qualify
- Ages
- 8 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCRαβ Depleted haploidentical HCTUse the CliniMACS TCRα/β deplete from the mobilized peripheral blood stem cells of haploidentical donor in children | Procedure or surgery | TCRαβ Depleted haploidentical HCT |
Primary outcome
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.
incidence of treatment related mortality(TRM)
Time frame: day +100
compare the incidence of TRM until Day 100 post-transplantation
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Chen, PhD principal investigator
Shanghai Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TCRαβ Depleted haploidentical HCT in people with Graft-Versus-Host Disease and Hematopoietic Stem Cell Transplantation, run by Sijia Gu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Chen, PhD (38626161 ext. 82073, chenjing@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade II-IV acute GVHD (time frame: day+100). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.