Cousin vs. Sibling Donors in Haplo-HSCT

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07662382

Enrollment

1000

Registered

2026-06-23

Start date

2026-08-01

Completion date

2027-10-31

Last updated

2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Donor, Haploidentical Hematopoietic Stem Cell Transplantation, Hematopoietic Malignancies

Brief 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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Overall survival	2 years after transplantation	estimated overall survival at 2 year
Graft-versus-host disease-free and relapse-free survival	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	180 days after transplantation	estimated cumulative incidence of acute graft-versus-host disease at 180 day
Cumulative incidence of chronic graft-versus-host disease	2 years after transplantation	estimated cumulative incidence of chronic graft-versus-host disease at 2 year

Secondary

Measure	Time frame	Description
Cumulative incidence of relapse	2 years after transplantation	estimated cumulative incidence of relapse at 2 year
Non-relapse mortality	2 years after transplantation	estimated non-relapse mortality at 2 year
Cumulative incidence of grade III-IV acute graft-versus-host disease	180 days after transplantation	estimated cumulative incidence of grade III-IV acute graft-versus-host disease at 180 day
Cumulative incidence of extensive chronic graft-versus-host disease	2 years after transplantation	estimated cumulative incidence of extensive chronic graft-versus-host disease at 2 year

Countries

China

Contacts

PRINCIPAL_INVESTIGATORYang Xu

The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

Outcome results