Engraftment SyndromeES after HSCTNCT07577375
Prospective Validation of Engraftment Syndrome Phenotypes and Outcomes After Hematopoietic Stem Cell Transplantation
An observational study of Engraftment Syndrome and Allo-HSCT, run by Xiao Hui Zhang.
Trial summary
Engraftment syndrome (ES) is an early inflammatory complication after hematopoietic stem cell transplantation (HSCT) and has been associated with subsequent transplant-related complications and adverse clinical outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Engraftment Syndrome, Allo-HSCT
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2029
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: The study population will include patients who develop engraftment syndrome after allogeneic hematopoietic stem cell transplantation at the participating center. Patients will be prospectively enrolled after the diagnosis of engraftment syndrome and followed for subsequent grade II-IV acute graft-versus-host disease and post-transplant outcomes, including overall survival, disease-free survival, relapse, and non-relapse mortality. Clinical features, laboratory parameters, engraftment kinetics, and organ-injury markers related to engraftment syndrome will be collected to validate ES phenotypes and their prognostic significance.
Who may be able to join
- Patients undergoing allogeneic hematopoietic stem cell transplantation at the participating center.
- Development of engraftment syndrome after hematopoietic stem cell transplantation, diagnosed according to predefined institutional or published clinical criteria.
- Availability of key clinical and laboratory data required for engraftment syndrome phenotyping, including engraftment kinetics, clinical manifestations, inflammatory markers, and organ-injury parameters.
- Ability to undergo prospective follow-up for post-transplant outcomes, including acute graft-versus-host disease and survival outcomes.
- Written informed consent provided by the patient or legally authorized representative, when required by the institutional review board or ethics committee.
Who cannot join
- Patients who do not develop engraftment syndrome after hematopoietic stem cell transplantation.
- Patients with insufficient clinical or laboratory data to confirm the diagnosis of engraftment syndrome.
- Patients with missing essential follow-up information for assessment of primary outcome measures.
- Patients who withdraw consent or decline participation in prospective follow-up.
- Patients enrolled in another study that, in the opinion of the investigators, may interfere with the observational assessment of engraftment syndrome phenotypes or post-transplant outcomes.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective Observational Cohort Study to Validate Engraftment Syndrome Phenotypes and Their Associations With Acute Graft-Versus-Host Disease and Clinical Outcomes After Hematopoietic Stem Cell Transplantation
Engraftment syndrome (ES) is an early inflammatory complication after hematopoietic stem cell transplantation (HSCT) and has been associated with subsequent transplant-related complications and adverse clinical outcomes. However, ES is clinically heterogeneous, and its relationship with acute graft-versus-host disease (aGVHD), survival, and other post-transplant outcomes remains incompletely defined.
This prospective observational cohort study aims to validate previously identified ES-associated risk factors, severity-oriented ES phenotypes, and their associations with grade II-IV aGVHD and clinical outcomes after HSCT. Patients undergoing HSCT will be prospectively followed for the development of ES, grade II-IV aGVHD, and clinical outcomes including overall survival, disease-free survival, relapse, and non-relapse mortality. The study will evaluate whether ES phenotypes and ES-related clinical characteristics can stratify patients according to subsequent aGVHD risk and post-transplant prognosis.
- Conditions
- Engraftment Syndrome, Allo-HSCT
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Engraftment Syndrome, allo-HSCT, acute GVHD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No study-specific intervention will be administered. Participants will receive standard clinical care after hematopoietic stem cell transplantation according to institutional practice and treating physician discretion. The study will prospectively collect observational data on engraftment syndrome characteristics, laboratory parameters, subsequent grade II-IV acute graft-versus-host disease, and clinical outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Engraftment Syndrome | Patients who develop engraftment syndrome after hematopoietic stem cell transplantation will be enrolled and prospectively followed. Engraftment syndrome will be diagnosed according to predefined clinical criteria during the early post-transplant period. Clinical features, laboratory parameters, transplant-related characteristics, ES phenotypes, subsequent grade II-IV acute graft-versus-host disease, and clinical outcomes will be recorded and analyzed. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Grade II-IV Acute Graft-Versus-Host Disease
Time from hematopoietic stem cell transplantation to the first diagnosis of grade II-IV acute graft-versus-host disease among patients with engraftment syndrome. Acute graft-versus-host disease will be graded according to institutional standard criteria.
Measured: From hematopoietic stem cell transplantation to the first diagnosis of grade II-IV acute graft-versus-host disease, assessed up to 180 days after transplantation.
Secondary outcomes (6)
Incidence of Grade II-IV Acute Graft-Versus-Host Disease
Proportion of participants who develop grade II-IV acute graft-versus-host disease after hematopoietic stem cell transplantation.
Measured: Up to 180 days after transplantation.
Incidence of Chronic Graft-Versus-Host Disease
Proportion of participants who develop chronic graft-versus-host disease after hematopoietic stem cell transplantation.
Measured: Up to 2 years after transplantation.
Overall Survival
Time from hematopoietic stem cell transplantation to death from any cause. Participants alive at the last follow-up will be censored.
Measured: From transplantation to death from any cause, assessed up to 2 years after transplantation.
Disease-Free Survival
Time from hematopoietic stem cell transplantation to relapse, disease progression, or death from any cause, whichever occurs first.
Measured: From transplantation to relapse, disease progression, or death from any cause, assessed up to 2 years after transplantation.
Cumulative Incidence of Relapse
Proportion of participants who experience relapse or disease progression after hematopoietic stem cell transplantation. Non-relapse death will be considered a competing event in competing-risk analyses.
Measured: Up to 2 years after transplantation.
Non-Relapse Mortality
Death without prior relapse or disease progression after hematopoietic stem cell transplantation. Relapse will be considered a competing event in competing-risk analyses.
Measured: Up to 2 years after transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Engraftment SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiao Hui Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Chinese Medicine, Zhuhai, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Affiliated Hospital of Zhengzhou University, The Third Xiangya Hospital of Central South University, The First Hospital of Jilin University, Guangzhou First People's Hospital
- Responsible party
- Sponsor-investigator, Xiao Hui Zhang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577375
- Sponsor's protocol ID
- ES-HSCT-001
- Acronym
- ES after HSCT
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Cohort Study to Validate Engraftment Syndrome Phenotypes and Their Associations With Acute Graft-Versus-Host Disease and Clinical Outcomes After Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07577375
- Acronym / sponsor ID
- ES after HSCT / ES-HSCT-001
- Conditions
- Engraftment Syndrome, Allo-HSCT
- Keywords
- Engraftment Syndrome, allo-HSCT, acute GVHD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Xiao Hui ZhangUniversity, hospital or other
- Collaborators
- Guangdong Provincial Hospital of Chinese Medicine, Zhuhai, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Affiliated Hospital of Zhengzhou University, The Third Xiangya Hospital of Central South University, The First Hospital of Jilin University, Guangzhou First People's Hospital
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 11 May 2026 (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.
Engraftment syndrome (ES) is an early inflammatory complication after hematopoietic stem cell transplantation (HSCT) and has been associated with subsequent transplant-related complications and adverse clinical outcomes. However, ES is clinically heterogeneous, and its relationship with acute graft-versus-host disease (aGVHD), survival, and other post-transplant outcomes remains incompletely defined.
This prospective observational cohort study aims to validate previously identified ES-associated risk factors, severity-oriented ES phenotypes, and their associations with grade II-IV aGVHD and clinical outcomes after HSCT. Patients undergoing HSCT will be prospectively followed for the development of ES, grade II-IV aGVHD, and clinical outcomes including overall survival, disease-free survival, relapse, and non-relapse mortality. The study will evaluate whether ES phenotypes and ES-related clinical characteristics can stratify patients according to subsequent aGVHD risk and post-transplant prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Engraftment Syndrome | – | Other: No Intervention: Observational CohortPatients who develop engraftment syndrome after hematopoietic stem cell transplantation will be enrolled and prospectively followed. Engraftment syndrome will be diagnosed according to predefined clinical criteria during the early post-transplant period. Clinical features, laboratory parameters, transplant-related characteristics, ES phenotypes, subsequent grade II-IV acute graft-versus-host disease, and clinical outcomes will be recorded and analyzed. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include patients who develop engraftment syndrome after allogeneic hematopoietic stem cell transplantation at the participating center. Patients will be prospectively enrolled after the diagnosis of engraftment syndrome and followed for subsequent grade II-IV acute graft-versus-host disease and post-transplant outcomes, including overall survival, disease-free survival, relapse, and non-relapse mortality. Clinical features, laboratory parameters, engraftment kinetics, and organ-injury markers related to engraftment syndrome will be collected to validate ES phenotypes and their prognostic significance.
Key inclusion criteria (5 listed)
- Patients undergoing allogeneic hematopoietic stem cell transplantation at the participating center.
- Development of engraftment syndrome after hematopoietic stem cell transplantation, diagnosed according to predefined institutional or published clinical criteria.
- Availability of key clinical and laboratory data required for engraftment syndrome phenotyping, including engraftment kinetics, clinical manifestations, inflammatory markers, and organ-injury parameters.
- Ability to undergo prospective follow-up for post-transplant outcomes, including acute graft-versus-host disease and survival outcomes.
- Written informed consent provided by the patient or legally authorized representative, when required by the institutional review board or ethics committee.
Key exclusion criteria (5 listed)
- Patients who do not develop engraftment syndrome after hematopoietic stem cell transplantation.
- Patients with insufficient clinical or laboratory data to confirm the diagnosis of engraftment syndrome.
- Patients with missing essential follow-up information for assessment of primary outcome measures.
- Patients who withdraw consent or decline participation in prospective follow-up.
- Patients enrolled in another study that, in the opinion of the investigators, may interfere with the observational assessment of engraftment syndrome phenotypes or post-transplant outcomes.
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 |
|---|---|---|
| No Intervention: Observational CohortNo study-specific intervention will be administered. Participants will receive standard clinical care after hematopoietic stem cell transplantation according to institutional practice and treating physician discretion. The study will prospectively collect observational data on engraftment syndrome characteristics, laboratory parameters, subsequent grade II-IV acute graft-versus-host disease, and clinical outcomes. | Other | Patients With Engraftment Syndrome |
Primary outcome
Time to Grade II-IV Acute Graft-Versus-Host Disease
Time frame: From hematopoietic stem cell transplantation to the first diagnosis of grade II-IV acute graft-versus-host disease, assessed up to 180 days after transplantation.
Time from hematopoietic stem cell transplantation to the first diagnosis of grade II-IV acute graft-versus-host disease among patients with engraftment syndrome. Acute graft-versus-host disease will be graded according to institutional standard criteria.
6 secondary outcomes
Incidence of Grade II-IV Acute Graft-Versus-Host Disease
Time frame: Up to 180 days after transplantation.
Incidence of Chronic Graft-Versus-Host Disease
Time frame: Up to 2 years after transplantation.
Overall Survival
Time frame: From transplantation to death from any cause, assessed up to 2 years after transplantation.
Disease-Free Survival
Time frame: From transplantation to relapse, disease progression, or death from any cause, assessed up to 2 years after transplantation.
Cumulative Incidence of Relapse
Time frame: Up to 2 years after transplantation.
Non-Relapse Mortality
Time frame: Up to 2 years after transplantation.
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 11 May 2026.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Engraftment Syndrome and Allo-HSCT, run by Xiao Hui Zhang.
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 5 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: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yejun Wu (+8618800181620, wyejun1999@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Grade II-IV Acute Graft-Versus-Host Disease (time frame: From hematopoietic stem cell transplantation to the first diagnosis of grade II-IV acute graft-versus-host disease, assessed up to 180 days after transplantation.). 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 11 May 2026.