Hematopoietic Stem Cell TransplantationPhase 4NCT04203108
ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis
A Phase 4 study testing ATG, CsA and MTX in people with Hematopoietic Stem Cell Transplantation, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
The protocols including ciclosporin A （CsA）+methotrexate (MTX) +mycophenolate Mofetil(MMF) have been widely used for graft-versus-host disease (GVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from HLA-matched sibling donor (MSD). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- ATG, CsA and MTX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 31 Dec 2022
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A patient age of 18-65 years
- MSD transplant recipient
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Who cannot join
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- Patients with any conditions not suitable for the trial (investigators' decision)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong
Ren Lin, +86-020-62787883, lansinglinren@hotmail.com
About this study
Official title: ATG Used in Allogeneic Hematopoietic Stem Cell Transplantation From HLA-matched Sibling Donor as GVHD Prophylaxis
The protocols including ciclosporin A （CsA）+methotrexate (MTX) +mycophenolate Mofetil(MMF) have been widely used for graft-versus-host disease (GVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from HLA-matched sibling donor (MSD). Nevertheless, severe chronic graft-versus-host disease (cGVHD) remains an obstacle for MSD HSCT. A growing body of studies have suggested antithymocyte globulin (ATG) could reduce the incidence of cGVHD. This study is aim to evaluate the efficacy of a protocol that includes CsA, MTX, MMF and ATG in recipients of MSD HSCT.
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- ATG, CsA, MTX, MMF
- Keywords
- Hematopoietic Stem Cell Transplantation, antithymocyte globulin, graft-versus-host disease
- 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.
ATGDrug
In ATG group, ATG will be intravenously infused via a central venous catheter in day -1 at a dose of 2.5mg/kg.
CsADrug
In both groups, CsA will be intravenously infused from day -9 and the dose was adjusted based on the concentration.
MTXDrug
In both groups, MTX will be intravenously on days +1(15mg), +3(10mg) and +6(10mg).
MMFDrug
In both groups, MMF will be administrated at a dose of 1.0g/d.
| Study group | Role | What they receive |
|---|---|---|
| ATG group | Experimental | ATG group refers to treatment with a protocol including low-dose ATG, CsA, short-term MTX and MMF as GVHD prophylaxis. Receives: Drug: ATG; Drug: CsA; Drug: MTX; Drug: MMF |
| non-ATG group | Active comparator | Non-ATG group refers to treatment with a protocol including CsA, short-term MTX and MMF as GVHD prophylaxis. Receives: Drug: CsA; Drug: MTX; Drug: MMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of cGVHD
cGVHD was graded as limited or extensive.
Measured: 2 year posttransplantation
Secondary outcomes (3)
overall survival
Measured: 2 year posttransplantation
disease-free survival
Measured: 2 year posttransplantation
the incidence of aGVHD
aGVHD was defined according to the 1994 Consensus Conference on Acute GVHD Grading and graded from I to IV.
Measured: 100 days 1 year posttransplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start1 Sep 2019
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qifa Liu, Nanfang Hospital, Southern Medical University
- Investigators
- Qifa Liu, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203108
- Sponsor's protocol ID
- ATG in HLA-matched HSCT-2019
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2019
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ATG Used in Allogeneic Hematopoietic Stem Cell Transplantation From HLA-matched Sibling Donor as GVHD Prophylaxis
- ClinicalTrials.gov ID
- NCT04203108
- Acronym / sponsor ID
- ATG in HLA-matched HSCT-2019
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- Hematopoietic Stem Cell Transplantation, antithymocyte globulin, graft-versus-host disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Dec 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.
The protocols including ciclosporin A （CsA）+methotrexate (MTX) +mycophenolate Mofetil(MMF) have been widely used for graft-versus-host disease (GVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from HLA-matched sibling donor (MSD). Nevertheless, severe chronic graft-versus-host disease (cGVHD) remains an obstacle for MSD HSCT. A growing body of studies have suggested antithymocyte globulin (ATG) could reduce the incidence of cGVHD. This study is aim to evaluate the efficacy of a protocol that includes CsA, MTX, MMF and ATG in recipients of MSD HSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATG group | Experimental | Drug: ATG, Drug: CsA, Drug: MTX, Drug: MMFATG group refers to treatment with a protocol including low-dose ATG, CsA, short-term MTX and MMF as GVHD prophylaxis. |
| non-ATG group | Active comparator | Drug: CsA, Drug: MTX, Drug: MMFNon-ATG group refers to treatment with a protocol including CsA, short-term MTX and MMF as GVHD prophylaxis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- A patient age of 18-65 years
- MSD transplant recipient
- Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Key exclusion criteria (2 listed)
- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- Patients with any conditions not suitable for the trial (investigators' decision)
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 |
|---|---|---|
| ATGIn ATG group, ATG will be intravenously infused via a central venous catheter in day -1 at a dose of 2.5mg/kg. | Drug | ATG group |
| CsAIn both groups, CsA will be intravenously infused from day -9 and the dose was adjusted based on the concentration. | Drug | ATG group, non-ATG group |
| MTXIn both groups, MTX will be intravenously on days +1(15mg), +3(10mg) and +6(10mg). | Drug | ATG group, non-ATG group |
| MMFIn both groups, MMF will be administrated at a dose of 1.0g/d. | Drug | ATG group, non-ATG group |
Primary outcome
the incidence of cGVHD
Time frame: 2 year posttransplantation
cGVHD was graded as limited or extensive.
3 secondary outcomes
overall survival
Time frame: 2 year posttransplantation
disease-free survival
Time frame: 2 year posttransplantation
the incidence of aGVHD
Time frame: 100 days 1 year posttransplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Individual participant dataSharing planned: Undecided
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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.
Qifa Liu principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ATG, CsA and MTX in people with Hematopoietic Stem Cell Transplantation, run by Nanfang Hospital, Southern 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 2 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 18 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ren Lin, MD (+86-020-62787883, lansinglinren@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of cGVHD (time frame: 2 year posttransplantation). 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 18 Dec 2019; AzTrials last refreshed its copy on 6 Nov 2026.