CD19-chimeric Antigen Receptor T CellsNCT03423706
Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation
A study testing the new model of haplo-HSCT for r/r B-ALL in people with CD19-chimeric Antigen Receptor T Cells and Relapsed and/or Refractory Acute Lymphoblastic Leukemia, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
Building a new haploid transplanted model with high-dose CTX、CD19-CART,donor CD34+ hematopoietic stem cell and Tregs,to prevent graft-versus-host disease(GVHD),reduce the infection,promote the rate of immune reconstruction，seperate graft versus leukemia（GVL）and GVHD，then to reduce the relapse rate after hematopoietic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CD19-chimeric Antigen Receptor T Cells, Relapsed and/or Refractory Acute Lymphoblastic Leukemia, the Haploidentical Hematopoietic Stem Cell Transplantation
- What is being tested?
- the new model of haplo-HSCT for r/r B-ALL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2018to Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- the r/r B-ALL patients
- have the healthy allo-HSCT donor
- voluntary and signed the treatment protocol
Who cannot join
- not match the inclusion criteria
- important organ is dysfunction, such as heart and/or renal dysfunction,liver failure
- Pregnancy or breast-feeding women
- has virus infection,such as HIV,hepatitis virus,and can not be cleared with anti-virus treatment
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150001
min li li, master, 13796615495, llilimin@163.com
About this study
Building a new haploid transplanted model with high-dose CTX、CD19-CART,donor CD34+ hematopoietic stem cell and Tregs,to prevent graft-versus-host disease(GVHD),reduce the infection,promote the rate of immune reconstruction，seperate graft versus leukemia（GVL）and GVHD，then to reduce the relapse rate after hematopoietic stem cell transplantation（HSCT）for relapsed and/or refractory B cell acute lymphoblastic leukemia（r/r-B-ALL）.
Read the detailed description
compare the new haplo-HSCT model with the traditional haplo-HSCT in DFS、OS、RFS、CR and the degree of GVHD.etc.for the r/r B-ALL patients.
- Conditions
- CD19-chimeric Antigen Receptor T Cells, Relapsed and/or Refractory Acute Lymphoblastic Leukemia, the Haploidentical Hematopoietic Stem Cell Transplantation
- Being tested
- the new model of haplo-HSCT for r/r B-ALL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the new model of haplo-HSCT for r/r B-ALLProcedure or surgery
take advantage of high-dose CTX、CD19-CART、donor CD34+HSC and Tregs to create a new model of haplo-HSCT for the patients in r/r B-ALL,to improve the quality of HSCT.
| Study group | Role | What they receive |
|---|---|---|
| new model of haplo-HSCT | Experimental | use the new model of haplo-HSCT to treat the r/r B-ALL patients matching the inclusion criterion Receives: Procedure: the new model of haplo-HSCT for r/r B-ALL |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival at six months
the disease free survival of the new model haplo-HSCT will be assessed at 6 months.
Measured: six months
acute graft-versus-host disease
we will examine the treatment-related acute GVHD at 3 months.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start7 May 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD19-chimeric Antigen Receptor T CellsStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jin zhou, doctor, Study chair, First affliliated hospital of Harbin medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423706
- Sponsor's protocol ID
- CART
- Status last verified
- Jan 2019
- First submitted
- 16 Jan 2018
- Last updated
- 17 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03423706
- Acronym / sponsor ID
- CART
- Conditions
- CD19-chimeric Antigen Receptor T Cells, Relapsed and/or Refractory Acute Lymphoblastic Leukemia, the Haploidentical Hematopoietic Stem Cell Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Feb 2018 (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.
Building a new haploid transplanted model with high-dose CTX、CD19-CART,donor CD34+ hematopoietic stem cell and Tregs,to prevent graft-versus-host disease(GVHD),reduce the infection,promote the rate of immune reconstruction，seperate graft versus leukemia（GVL）and GVHD，then to reduce the relapse rate after hematopoietic stem cell transplantation（HSCT）for relapsed and/or refractory B cell acute lymphoblastic leukemia（r/r-B-ALL）.
Detailed description
compare the new haplo-HSCT model with the traditional haplo-HSCT in DFS、OS、RFS、CR and the degree of GVHD.etc.for the r/r B-ALL patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| new model of haplo-HSCT | Experimental | Procedure: the new model of haplo-HSCT for r/r B-ALLuse the new model of haplo-HSCT to treat the r/r B-ALL patients matching the inclusion criterion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- the r/r B-ALL patients
- have the healthy allo-HSCT donor
- voluntary and signed the treatment protocol
Key exclusion criteria (4 listed)
- not match the inclusion criteria
- important organ is dysfunction, such as heart and/or renal dysfunction,liver failure
- Pregnancy or breast-feeding women
- has virus infection,such as HIV,hepatitis virus,and can not be cleared with anti-virus treatment
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 |
|---|---|---|
| the new model of haplo-HSCT for r/r B-ALLtake advantage of high-dose CTX、CD19-CART、donor CD34+HSC and Tregs to create a new model of haplo-HSCT for the patients in r/r B-ALL,to improve the quality of HSCT. | Procedure or surgery | new model of haplo-HSCT |
Primary outcome
disease free survival at six months
Time frame: six months
the disease free survival of the new model haplo-HSCT will be assessed at 6 months.
acute graft-versus-host disease
Time frame: three months
we will examine the treatment-related acute GVHD at 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
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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.
jin zhou, doctor study chair
First affliliated hospital of Harbin medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the new model of haplo-HSCT for r/r B-ALL in people with CD19-chimeric Antigen Receptor T Cells and Relapsed and/or Refractory Acute Lymphoblastic Leukemia, run by First Affiliated Hospital of Harbin Medical University 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 3 inclusion and 4 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 17 Dec 2019. 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 min li li, master (13796615495, llilimin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival at six months (time frame: six months). 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 17 Dec 2019.