A Target Trial Emulation StudyNCT07666568
Younger vs. Older Donors in Allo-HSCT: TTE
An observational study of A Target Trial Emulation Study and Donor Age, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Hematopoietic stem cell transplantation is an important therapeutic approach for hematologic malignancies, and the impact of donor age on transplant outcomes remains an active area of investigation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- A Target Trial Emulation Study, Donor Age, ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2026to 21 Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study includes adult patients with hematologic malignancies who underwent allogeneic hematopoietic stem cell transplantation at the study center. Eligible patients will be identified from retrospective clinical records and grouped according to donor age recorded at the time of transplantation.
Who may be able to join
- Age 18 years or older.
- Diagnosis of hematologic malignancy.
- Underwent first allogeneic hematopoietic stem cell transplantation.
- HLA matching level of 0.5 or higher.
- Available donor age information.
- Available clinical follow-up and outcome data.
Who cannot join
- Previous autologous or allogeneic hematopoietic stem cell transplantation.
- HLA matching level below 0.5.
- Missing donor age information.
- Missing key exposure-defining or outcome-defining data required for the analysis.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: Prognostic Comparison of Allogeneic Hematopoietic Stem Cell Transplantation Using Younger Versus Older Donors: A Target Trial Emulation Study
Hematopoietic stem cell transplantation is an important therapeutic approach for hematologic malignancies, and the impact of donor age on transplant outcomes remains an active area of investigation. Older donors may be associated with impaired stem cell fitness, delayed immune reconstitution, and reduced T-cell function. However, randomized controlled trials directly comparing transplant outcomes by donor age are difficult to conduct because of ethical constraints, and previous retrospective studies have yielded inconsistent findings due to confounding bias and limited causal interpretability. Target trial emulation (TTE) is a methodological framework that uses observational data to emulate the design principles of a randomized trial, thereby reducing biases such as immortal time bias, time-varying confounding, and prevalent-user bias, and improving the validity of causal inference. Therefore, this study will use a large single-center retrospective clinical cohort to perform a TTE analysis, aiming to approximate the causal framework of an randomized trial and systematically evaluate the effect of donor age on clinical outcomes after allo-HSCT, thereby providing higher-quality evidence to optimize donor selection strategies.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Younger Donor Group | Patients who underwent allogeneic hematopoietic stem cell transplantation with donors younger than 50 years. Grouping was based on donor age recorded in retrospective clinical data. | |
| Older Donor Group | Patients who underwent allogeneic hematopoietic stem cell transplantation with donors aged 50 years or older. Grouping was based on donor age recorded in retrospective clinical data. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival was defined as the interval between hematopoietic stem cell transplantation and death from any cause.
Measured: From the date of transplantation to the date of death from any cause or last follow-up, assessed up to 15 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion21 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for A Target Trial Emulation StudyStudies 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
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666568
- Sponsor's protocol ID
- TTE DONOR AGE
- Status last verified
- Jun 2026
- First submitted
- 15 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Comparison of Allogeneic Hematopoietic Stem Cell Transplantation Using Younger Versus Older Donors: A Target Trial Emulation Study
- ClinicalTrials.gov ID
- NCT07666568
- Acronym / sponsor ID
- TTE DONOR AGE
- Conditions
- A Target Trial Emulation Study, Donor Age, ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 21 Dec 2027 (estimated)
- First posted
- 24 Jun 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.
Hematopoietic stem cell transplantation is an important therapeutic approach for hematologic malignancies, and the impact of donor age on transplant outcomes remains an active area of investigation. Older donors may be associated with impaired stem cell fitness, delayed immune reconstitution, and reduced T-cell function. However, randomized controlled trials directly comparing transplant outcomes by donor age are difficult to conduct because of ethical constraints, and previous retrospective studies have yielded inconsistent findings due to confounding bias and limited causal interpretability. Target trial emulation (TTE) is a methodological framework that uses observational data to emulate the design principles of a randomized trial, thereby reducing biases such as immortal time bias, time-varying confounding, and prevalent-user bias, and improving the validity of causal inference. Therefore, this study will use a large single-center retrospective clinical cohort to perform a TTE analysis, aiming to approximate the causal framework of an randomized trial and systematically evaluate the effect of donor age on clinical outcomes after allo-HSCT, thereby providing higher-quality evidence to optimize donor selection strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Younger Donor Group | – | –Patients who underwent allogeneic hematopoietic stem cell transplantation with donors younger than 50 years. Grouping was based on donor age recorded in retrospective clinical data. |
| Older Donor Group | – | –Patients who underwent allogeneic hematopoietic stem cell transplantation with donors aged 50 years or older. Grouping was based on donor age recorded in retrospective clinical data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes adult patients with hematologic malignancies who underwent allogeneic hematopoietic stem cell transplantation at the study center. Eligible patients will be identified from retrospective clinical records and grouped according to donor age recorded at the time of transplantation.
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Diagnosis of hematologic malignancy.
- Underwent first allogeneic hematopoietic stem cell transplantation.
- HLA matching level of 0.5 or higher.
- Available donor age information.
Key exclusion criteria (4 listed)
- Previous autologous or allogeneic hematopoietic stem cell transplantation.
- HLA matching level below 0.5.
- Missing donor age information.
- Missing key exposure-defining or outcome-defining data required for the analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival
Time frame: From the date of transplantation to the date of death from any cause or last follow-up, assessed up to 15 years.
Overall survival was defined as the interval between hematopoietic stem cell transplantation and death from any cause.
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 24 Jun 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of A Target Trial Emulation Study and Donor Age, run by The First Affiliated Hospital of Soochow 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 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: opening soon, as of the sponsor's last update on 24 Jun 2026. 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?
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 Yang Xu (+86-512-67781850, xuyang1020@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From the date of transplantation to the date of death from any cause or last follow-up, assessed up to 15 years.). 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 24 Jun 2026.