Relapsed Pediatric ALLNCT04033627
TCDαβ/CD45RA Haploidentical Transplantation in Children With Leukemia
A study testing In Vitro T cells depletion using CliniMCAS system in people with Relapsed Pediatric ALL and Acute Graft-Versus-Host Disease (Gvhd) Grade IV (Diagnosis), run by Shanghai Children's Medical Center at 1 site in China.
Trial summary
This is a multi-center clinical study in China using CliniMACS TCRα/β+ and CD45RA+ T cell depleted stem cell grafts from haploidentical donors for hematopoietic stem cell transplantation in children. Read more about this study
- Who is it for?
- Ages 2 months to 18 years
- Conditions the study is for
- Relapsed Pediatric ALL, Acute Graft-Versus-Host Disease (Gvhd) Grade IV (Diagnosis), Relapsed Pediatric AML
- What is being tested?
- In Vitro T cells depletion using CliniMCAS system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2020to 8 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients with hematological malignancies in complete remission (CR), partial remission (PR) or with stable disease
- Acute myeloid leukemia (AML):
- Patients with high-risk AML in CR1 Patients with relapsed or primary therapy-refractory AML
- Acute lymphoid leukemia (ALL):
- Patients with high-risk ALL in CR1 Patients with relapsed or primary refractory ALL
Who cannot join
- Age >18 years or <8 weeks
- Patients with progressive disease prior HCT
- <3 months after preceding hematopoietic cell transplantation (HCT)
- History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukencephalopathy, active CNS infection)
- Fungal infections with radiological and clinical progression
- Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher than 400 U/L
Show all 16Show fewer
- Chronic active viral hepatitis
- Ejection fraction <40% or shortening fraction <25% on echocardiography
- Patients with > grade II hypertension by Common Toxicity Criteria (CTC)
- Creatinine clearance below threshold defined for stem cell transplantation according to local clinical standard
- Respiratory failure necessitating supplemental oxygen
- HIV infection
- Concurrent severe or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which by assessment of the treating physician could compromise participation in the study
- Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction)
- Patients unwilling or unable to comply with the protocol or unable to give informed consent
- Treatment with any investigational product within 4 weeks prior to study treatment (transfusion of the IMP)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Children's Medical Center
Shanghai
Jing Chen, 18930830632, chenjing@scmc.com.cn
About this study
Official title: A Multi-center Prospective Clinical Study in China Using CliniMACS TCRα/β+ and CD45RA+ T Cell Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Stem Cell Transplantation in Children With Leukemia
This is a multi-center clinical study in China using CliniMACS TCRα/β+ and CD45RA+ T cell depleted stem cell grafts from haploidentical donors for hematopoietic stem cell transplantation in children.
Read the detailed description
This clinical study will the CliniMACS TCRα/β and CD45RA Systems to deplete TCRα/β+ and CD45RA+ cells from the mobilized peripheral blood stem cells of a haploidentical donors to treat pediatric patients who were suffuring form relapsed or refactory leukemia.
Aming to evaluate the safety/tolerability and feasibility of haploidentical PBSC grafts depleted of TCRα/β+ and CD45RA+ cells using the CliniMACS TCRαβ/CD45RA System in pediatric patients with hematological malignancies diseases. And the incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation of this new In Vitro T cell depletion technology in China.
The investigators will monitor the incidence of grade I acute GVHD until Day 100 post-transplantation, incidence and severity of chronic GVHD after 1 year and 2 years, incidence of NRM at all visits throughout the study, and graft failure from Day 0 to Day 28 at the same time.
- Conditions
- Relapsed Pediatric ALL, Acute Graft-Versus-Host Disease (Gvhd) Grade IV (Diagnosis), Relapsed Pediatric AML
- Being tested
- In Vitro T cells depletion using CliniMCAS system
- Keywords
- In Vitro T cell depletion, haploidentical transplantation, GVHD, leukemia, TCRab, CD45RA, CliniMACS
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Graft vs Host Disease, Disease, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Vitro T cells depletion using CliniMCAS systemProcedure or surgery
Use the CliniMACS TCRα/β and CD45 Systems to deplete TCRα/β+ and CD45RA+ cells from the mobilized peripheral blood stem cells of a haploidentical donor in patients with leukemia.
| Study group | Role | What they receive |
|---|---|---|
| In Vitro T cell depletion | Experimental | Use the CliniMACS TCRα/β and CD45 Systems to deplete TCRα/β+ and CD45RA+ cells from the mobilized peripheral blood stem cells of a haploidentical donor in patients with leukemia. Receives: Procedure: In Vitro T cells depletion using CliniMCAS system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Log number of In Vitro T cells depletion
Log number of In Vitro T cells depletion using CliniMACS TCRab/CD45RA system.
Measured: One week
Incidence of grade II-IV acute GVHD
Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation.
Measured: up to 3 months
Secondary outcomes (4)
Grade I aGVHD
Incidence of grade I acute GVHD until Day 100 post-transplantation
Measured: up to 3 months
cGVHD
Incidence and severity of chronic GVHD in 1 year and 2 years
Measured: 2 years
NRM
Incidence of NRM at all visits throughout the study
Measured: 1 year
Graft failure
incidence of Graft failure from Day 0 to Day 28
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start10 Nov 2020
- Primary completion18 Jul 2022
- Study completion8 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Pediatric ALLStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Children's Hospital of Soochow University, Chinese University of Hong Kong, Miltenyi Biomedicine GmbH
- Responsible party
- Sponsor
- Investigators
- Jing Chen, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033627
- Sponsor's protocol ID
- TCD Haplo
- Status last verified
- Sep 2022
- First submitted
- 12 Jun 2019
- Last updated
- 29 Sep 2022
- 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 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Prospective Clinical Study in China Using CliniMACS TCRα/β+ and CD45RA+ T Cell Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Stem Cell Transplantation in Children With Leukemia
- ClinicalTrials.gov ID
- NCT04033627
- Acronym / sponsor ID
- TCD Haplo
- Conditions
- Relapsed Pediatric ALL, Acute Graft-Versus-Host Disease (Gvhd) Grade IV (Diagnosis), Relapsed Pediatric AML
- Keywords
- In Vitro T cell depletion, haploidentical transplantation, GVHD, leukemia, TCRab, CD45RA, CliniMACS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Children's Hospital of Soochow University, Chinese University of Hong Kong, Miltenyi Biomedicine GmbH
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 18 Jul 2022 (actual)
- Study completion
- 8 May 2024 (estimated)
- First posted
- 26 Jul 2019 (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 multi-center clinical study in China using CliniMACS TCRα/β+ and CD45RA+ T cell depleted stem cell grafts from haploidentical donors for hematopoietic stem cell transplantation in children.
Detailed description
This clinical study will the CliniMACS TCRα/β and CD45RA Systems to deplete TCRα/β+ and CD45RA+ cells from the mobilized peripheral blood stem cells of a haploidentical donors to treat pediatric patients who were suffuring form relapsed or refactory leukemia.
Aming to evaluate the safety/tolerability and feasibility of haploidentical PBSC grafts depleted of TCRα/β+ and CD45RA+ cells using the CliniMACS TCRαβ/CD45RA System in pediatric patients with hematological malignancies diseases. And the incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation of this new In Vitro T cell depletion technology in China.
The investigators will monitor the incidence of grade I acute GVHD until Day 100 post-transplantation, incidence and severity of chronic GVHD after 1 year and 2 years, incidence of NRM at all visits throughout the study, and graft failure from Day 0 to Day 28 at the same time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In Vitro T cell depletion | Experimental | Procedure: In Vitro T cells depletion using CliniMCAS systemUse the CliniMACS TCRα/β and CD45 Systems to deplete TCRα/β+ and CD45RA+ cells from the mobilized peripheral blood stem cells of a haploidentical donor in patients with leukemia. |
Who may qualify
- Ages
- 2 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Pediatric patients with hematological malignancies in complete remission (CR), partial remission (PR) or with stable disease
- Acute myeloid leukemia (AML):
- Patients with high-risk AML in CR1 Patients with relapsed or primary therapy-refractory AML
- Acute lymphoid leukemia (ALL):
- Patients with high-risk ALL in CR1 Patients with relapsed or primary refractory ALL
Key exclusion criteria (16 listed)
- Age >18 years or <8 weeks
- Patients with progressive disease prior HCT
- <3 months after preceding hematopoietic cell transplantation (HCT)
- History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukencephalopathy, active CNS infection)
- Fungal infections with radiological and clinical progression
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 |
|---|---|---|
| In Vitro T cells depletion using CliniMCAS systemUse the CliniMACS TCRα/β and CD45 Systems to deplete TCRα/β+ and CD45RA+ cells from the mobilized peripheral blood stem cells of a haploidentical donor in patients with leukemia. | Procedure or surgery | In Vitro T cell depletion |
Primary outcome
Log number of In Vitro T cells depletion
Time frame: One week
Log number of In Vitro T cells depletion using CliniMACS TCRab/CD45RA system.
Incidence of grade II-IV acute GVHD
Time frame: up to 3 months
Incidence of grade II-IV acute graft-versus-host disease (GVHD) until Day 100 post-transplantation.
4 secondary outcomes
Grade I aGVHD
Time frame: up to 3 months
cGVHD
Time frame: 2 years
NRM
Time frame: 1 year
Graft failure
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- 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. This study is not recruiting at the moment.
Jing Chen 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 In Vitro T cells depletion using CliniMCAS system in people with Relapsed Pediatric ALL and Acute Graft-Versus-Host Disease (Gvhd) Grade IV (Diagnosis), run by Shanghai Children's Medical Center 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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 29 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact luo chengjuan (+86 021 38626161 ext. 82030, luochengjuan@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Log number of In Vitro T cells depletion (time frame: One week). 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 Sep 2022.