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Not yet recruiting NCT07662382

Cousin vs. Sibling Donors in Haplo-HSCT

Observational Hematopoietic Malignancies Haploidentical Hematopoietic Stem Cell Transplantation Donor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hematopoietic Malignancies, Haploidentical Hematopoietic Stem Cell Transplantation, Donor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Primary outcome measures

  • Overall survival [Time frame: 2 years after transplantation]
  • Graft-versus-host disease-free and relapse-free survival [Time frame: 2 years after transplantation]
  • Cumulative incidence of acute graft-versus-host disease [Time frame: 180 days after transplantation]
  • Cumulative incidence of chronic graft-versus-host disease [Time frame: 2 years after transplantation]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The First Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT07662382 · TTE2026610

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗