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NCT Number: NCT07662382

Cousin vs. Sibling Donors in Haplo-HSCT

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.

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Key information

Conditions

Hematopoietic Malignancies Donor Haploidentical Hematopoietic Stem Cell Transplantation Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 2 years after transplantation

    estimated overall survival at 2 year

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Cumulative incidence of relapse

    Time frame: 2 years after transplantation

    estimated cumulative incidence of relapse at 2 year

  2. Non-relapse mortality

    Time frame: 2 years after transplantation

    estimated non-relapse mortality at 2 year

  3. Cumulative incidence of grade III-IV acute graft-versus-host disease

    Time frame: 180 days after transplantation

    estimated cumulative incidence of grade III-IV acute graft-versus-host disease at 180 day

  4. Cumulative incidence of extensive chronic graft-versus-host disease

    Time frame: 2 years after transplantation

    estimated cumulative incidence of extensive chronic graft-versus-host disease at 2 year

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Collaborators

  • Nanfang Hospital, Southern Medical University
  • Ruijin Hospital
  • Zhejiang University

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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