Hematopoietic MalignanciesNCT07662382
Cousin vs. Sibling Donors in Haplo-HSCT
An observational study of Hematopoietic Malignancies and Haploidentical Hematopoietic Stem Cell Transplantation, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This observational study aims to emulate a hypothetical pragmatic, multicenter, non-blinded clinical trial enrolling adult patients undergoing haploidentical hematopoietic stem cell transplantation (haplo-HSCT) with grafts derived from either cousin or sibiling donors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Malignancies, Haploidentical Hematopoietic Stem Cell Transplantation, Donor
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Oct 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 multicenter, retrospective observational study included adult patients with hematological malignancies undergoing their first haploidentical hematopoietic stem cell transplantation at four clinical centers between 2017 to 2024. Eligible patients were identified through retrospective clinical records and stratified by donor kinship recorded at transplant, classified as either cousin or sibling donor graft recipients.
Who may be able to join
- Adult patients diagnosed with hematological malignancies, including acute leukemia (AL), chronic myeloid leukemia (CML), myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), and non-Hodgkin lymphoma (NHL)
- Receipt of first haploidentical hematopoietic stem cell transplantation between 2017 and 2024
- Documented exact date of transplantation available in medical charts
- Verifiable donor kinship classified as either cousin or sibiling
- Complete longitudinal follow-up data accessible for outcome assessment
Who cannot join
- Prior receipt of any form of hematopoietic stem cell transplantation
- An age difference of more than 18 years between the donor and recipient
- Failure of successful infusion of donor-derived hematopoietic stem cells following conditioning regimen
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: Comparison of Outcomes of Haploidentical Hematopoietic Stem Cell Transplantation From Cousin Donors Versus Sibling Donors in Patients With Hematological Malignancies: A Target Trial Emulation Study
This observational study aims to emulate a hypothetical pragmatic, multicenter, non-blinded clinical trial enrolling adult patients undergoing haploidentical hematopoietic stem cell transplantation (haplo-HSCT) with grafts derived from either cousin or sibiling donors.
The main research question is whether cousin donor-derived haplo-HSCT is associated with inferior clinical outcomes relative to sibling donor-derived haplo-HSCT.
Study participants consist of adult patients diagnosed with hematological malignancies who underwent cousin or sibiling haplo-HSCT between 2017 and 2024, and all eligible recipients will receive regular follow-up assessments.
- Medical subject headings
- Hematologic Neoplasms
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 |
|---|---|---|
| Cousin haplo-HSCT | Patients who underwent haploidentical hematopoietic stem cell transplantation with cousin donors. Grouping was based on donor age recorded in retrospective clinical data. | |
| Sibling haplo-HSCT | Patients who underwent haploidentical hematopoietic stem cell transplantation with sibling donors. 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
estimated overall survival at 2 year
Measured: 2 years after transplantation
Graft-versus-host disease-free and relapse-free survival
estimated graft-versus-host disease-free and relapse-free survival at 2 year
Measured: 2 years after transplantation
Cumulative incidence of acute graft-versus-host disease
estimated cumulative incidence of acute graft-versus-host disease at 180 day
Measured: 180 days after transplantation
Cumulative incidence of chronic graft-versus-host disease
estimated cumulative incidence of chronic graft-versus-host disease at 2 year
Measured: 2 years after transplantation
Secondary outcomes (4)
Cumulative incidence of relapse
estimated cumulative incidence of relapse at 2 year
Measured: 2 years after transplantation
Non-relapse mortality
estimated non-relapse mortality at 2 year
Measured: 2 years after transplantation
Cumulative incidence of grade III-IV acute graft-versus-host disease
estimated cumulative incidence of grade III-IV acute graft-versus-host disease at 180 day
Measured: 180 days after transplantation
Cumulative incidence of extensive chronic graft-versus-host disease
estimated cumulative incidence of extensive chronic graft-versus-host disease at 2 year
Measured: 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 posted23 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic MalignanciesStudies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, Nanfang Hospital, Southern Medical University, Zhejiang University
- Responsible party
- Sponsor
- Investigators
- Yang Xu, Principal investigator, The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662382
- Sponsor's protocol ID
- TTE2026610
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes of Haploidentical Hematopoietic Stem Cell Transplantation From Cousin Donors Versus Sibling Donors in Patients With Hematological Malignancies: A Target Trial Emulation Study
- ClinicalTrials.gov ID
- NCT07662382
- Acronym / sponsor ID
- TTE2026610
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Ruijin Hospital, Nanfang Hospital, Southern Medical University, Zhejiang University
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 23 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.
This observational study aims to emulate a hypothetical pragmatic, multicenter, non-blinded clinical trial enrolling adult patients undergoing haploidentical hematopoietic stem cell transplantation (haplo-HSCT) with grafts derived from either cousin or sibiling donors.
The main research question is whether cousin donor-derived haplo-HSCT is associated with inferior clinical outcomes relative to sibling donor-derived haplo-HSCT.
Study participants consist of adult patients diagnosed with hematological malignancies who underwent cousin or sibiling haplo-HSCT between 2017 and 2024, and all eligible recipients will receive regular follow-up assessments.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cousin haplo-HSCT | – | –Patients who underwent haploidentical hematopoietic stem cell transplantation with cousin donors. Grouping was based on donor age recorded in retrospective clinical data. |
| Sibling haplo-HSCT | – | –Patients who underwent haploidentical hematopoietic stem cell transplantation with sibling donors. 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 multicenter, retrospective observational study included adult patients with hematological malignancies undergoing their first haploidentical hematopoietic stem cell transplantation at four clinical centers between 2017 to 2024. Eligible patients were identified through retrospective clinical records and stratified by donor kinship recorded at transplant, classified as either cousin or sibling donor graft recipients.
Key inclusion criteria (5 listed)
- Adult patients diagnosed with hematological malignancies, including acute leukemia (AL), chronic myeloid leukemia (CML), myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), and non-Hodgkin lymphoma (NHL)
- Receipt of first haploidentical hematopoietic stem cell transplantation between 2017 and 2024
- Documented exact date of transplantation available in medical charts
- Verifiable donor kinship classified as either cousin or sibiling
- Complete longitudinal follow-up data accessible for outcome assessment
Key exclusion criteria (3 listed)
- Prior receipt of any form of hematopoietic stem cell transplantation
- An age difference of more than 18 years between the donor and recipient
- Failure of successful infusion of donor-derived hematopoietic stem cells following conditioning regimen
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: 2 years after transplantation
estimated overall survival at 2 year
Graft-versus-host disease-free and relapse-free survival
Time frame: 2 years after transplantation
estimated graft-versus-host disease-free and relapse-free survival at 2 year
Cumulative incidence of acute graft-versus-host disease
Time frame: 180 days after transplantation
estimated cumulative incidence of acute graft-versus-host disease at 180 day
Cumulative incidence of chronic graft-versus-host disease
Time frame: 2 years after transplantation
estimated cumulative incidence of chronic graft-versus-host disease at 2 year
4 secondary outcomes
Cumulative incidence of relapse
Time frame: 2 years after transplantation
Non-relapse mortality
Time frame: 2 years after transplantation
Cumulative incidence of grade III-IV acute graft-versus-host disease
Time frame: 180 days after transplantation
Cumulative incidence of extensive chronic graft-versus-host disease
Time frame: 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 23 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.
Yang Xu principal investigator
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
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 Hematopoietic Malignancies and Haploidentical Hematopoietic Stem Cell Transplantation, 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 5 inclusion and 3 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 23 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 2 years after transplantation). The study lists 4 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 23 Jun 2026.