NCT07662382

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.

Trial Health

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Trial Health Score

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Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 16, 2026

Last Update Submit

June 16, 2026

Conditions

Hematopoietic MalignanciesHaploidentical Hematopoietic Stem Cell TransplantationDonor

Outcome Measures

Primary Outcomes (4)

  • Overall survival

    estimated overall survival at 2 year

    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

    2 years after transplantation

  • Cumulative incidence of acute graft-versus-host disease

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

    180 days after transplantation

  • Cumulative incidence of chronic graft-versus-host disease

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

    2 years after transplantation

Secondary Outcomes (4)

  • Cumulative incidence of relapse

    2 years after transplantation

  • Non-relapse mortality

    2 years after transplantation

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

    180 days after transplantation

  • Cumulative incidence of extensive chronic graft-versus-host disease

    2 years after transplantation

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Yang Xu

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 23, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)