GVHD in the Setting of Haplo-HSCTPhase 2/3NCT03631563
ATG-F VS ATG for the Prevention of GVHD
A Phase 2/3 study testing Immunosuppressive Agent in people with GVHD in the Setting of Haplo-HSCT, run by Fujian Medical University at 1 site in China.
Trial summary
Anti-thymocyte globulin (ATG) preparative regimen in the setting of haploidentical stem cell transplantation (haplo-HSCT) is vital for inducing immune tolerance.The study aims to compare the efficacy and safety of ATG-F vs ATG, incorporated into the preparative regimens for haplo-identical transplants. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- GVHD in the Setting of Haplo-HSCT
- What is being tested?
- Immunosuppressive Agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2013to 1 Dec 2020
- Phase
- Phase 2/3
- 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 Up to 65 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Signed written informed consent
- Aged <65 years
- Patients undergoing Haplo-identical hematopoietic stem cell transplantation.
- Cardiac: Left ventricular ejection fraction ≥ 50%
- Adequate renal and hepatic function
- Performance status: Karnofsky ≥ 70%
Who cannot join
- Pregnant or lactating females.
- Any co-morbidity precluding the administration of ATG or ATG-F.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Ting Yang, Prof.M.D.Ph.D, 86-13950210357, yang.hopeting@gmail.com
About this study
Official title: Comparing ATG-Fresenius vs Thymoglobulin for the Prevention of Graft-versus-host Disease in the Setting of Haplo-identical Hematopoietic Stem Cell Transplantation
Anti-thymocyte globulin (ATG) preparative regimen in the setting of haploidentical stem cell transplantation (haplo-HSCT) is vital for inducing immune tolerance.The study aims to compare the efficacy and safety of ATG-F vs ATG, incorporated into the preparative regimens for haplo-identical transplants.
- Conditions
- GVHD in the Setting of Haplo-HSCT
- Being tested
- Immunosuppressive Agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunosuppressive AgentDrug
ATG-Fresenius versus ATG
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | ATG-F treated Receives: Drug: Immunosuppressive Agent |
| Arm 2 | Active comparator | ATG treated Receives: Drug: Immunosuppressive Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of GVHD
Measured: 1 year
Secondary outcomes (2)
leukemia-free survival
Measured: 1 year
treatment-related mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Mar 2013
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GVHD in the Setting of Haplo-HSCTStudies of the same condition, open and under way.
- More trials run by Fujian 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting YANG, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631563
- Sponsor's protocol ID
- ATG-F VS ATG-01
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2018
- Last updated
- 15 Aug 2018
- 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 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing ATG-Fresenius vs Thymoglobulin for the Prevention of Graft-versus-host Disease in the Setting of Haplo-identical Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03631563
- Acronym / sponsor ID
- ATG-F VS ATG-01
- Conditions
- GVHD in the Setting of Haplo-HSCT
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 15 Aug 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.
Anti-thymocyte globulin (ATG) preparative regimen in the setting of haploidentical stem cell transplantation (haplo-HSCT) is vital for inducing immune tolerance.The study aims to compare the efficacy and safety of ATG-F vs ATG, incorporated into the preparative regimens for haplo-identical transplants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Immunosuppressive AgentATG-F treated |
| Arm 2 | Active comparator | Drug: Immunosuppressive AgentATG treated |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Signed written informed consent
- Aged <65 years
- Patients undergoing Haplo-identical hematopoietic stem cell transplantation.
- Cardiac: Left ventricular ejection fraction ≥ 50%
- Adequate renal and hepatic function
Key exclusion criteria (2 listed)
- Pregnant or lactating females.
- Any co-morbidity precluding the administration of ATG or ATG-F.
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 |
|---|---|---|
| Immunosuppressive AgentATG-Fresenius versus ATG | Drug | Arm 1, Arm 2 |
Primary outcome
incidence of GVHD
Time frame: 1 year
2 secondary outcomes
leukemia-free survival
Time frame: 1 year
treatment-related mortality
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Immunosuppressive Agent in people with GVHD in the Setting of Haplo-HSCT, run by Fujian 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 6 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 15 Aug 2018. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ting Yang, Prof.M.D.Ph.D (86-13950210357, yang.hopeting@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of GVHD (time frame: 1 year). 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 15 Aug 2018.