Cousin vs. Sibling Donors in Haplo-HSCT
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Soochow University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 2 trial groupsGroup A: Cousin haplo-HSCT
Group B: Sibling haplo-HSCT
Trial outcomes
Primary outcomes
1
Overall survival
estimated overall survival at 2 year
Time frame
2 years after transplantation2
Graft-versus-host disease-free and relapse-free survival
estimated graft-versus-host disease-free and relapse-free survival at 2 year
Time frame
2 years after transplantation3
Cumulative incidence of acute graft-versus-host disease
estimated cumulative incidence of acute graft-versus-host disease at 180 day
Time frame
180 days after transplantation4
Cumulative incidence of chronic graft-versus-host disease
estimated cumulative incidence of chronic graft-versus-host disease at 2 year
Time frame
2 years after transplantationSecondary outcomes
1
Cumulative incidence of relapse
estimated cumulative incidence of relapse at 2 year
Time frame
2 years after transplantation2
Non-relapse mortality
estimated non-relapse mortality at 2 year
Time frame
2 years after transplantation3
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
Time frame
180 days after transplantation4
Cumulative incidence of extensive chronic graft-versus-host disease
estimated cumulative incidence of extensive chronic graft-versus-host disease at 2 year
Time frame
2 years after transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
The First Affiliated Hospital of Soochow University
Lead sponsor
Ruijin Hospital
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
Zhejiang University
Collaborator
Source ClinicalTrials.gov
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