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Not yet recruiting NCT07666568

Younger vs. Older Donors in Allo-HSCT: TTE

Observational A Target Trial Emulation Study Donor Age ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION

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: A Target Trial Emulation Study, Donor Age, ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION. 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

Prognostic Comparison of Allogeneic Hematopoietic Stem Cell Transplantation Using Younger Versus Older Donors: A Target Trial Emulation Study

Overview

Hematopoietic stem cell transplantation is an important therapeutic approach for hematologic malignancies, and the impact of donor age on transplant outcomes remains an active area of investigation. Older donors may be associated with impaired stem cell fitness, delayed immune reconstitution, and reduced T-cell function. However, randomized controlled trials directly comparing transplant outcomes by donor age are difficult to conduct because of ethical constraints, and previous retrospective studies have yielded inconsistent findings due to confounding bias and limited causal interpretability. Target trial emulation (TTE) is a methodological framework that uses observational data to emulate the design principles of a randomized trial, thereby reducing biases such as immortal time bias, time-varying confounding, and prevalent-user bias, and improving the validity of causal inference. Therefore, this study will use a large single-center retrospective clinical cohort to perform a TTE analysis, aiming to approximate the causal framework of an randomized trial and systematically evaluate the effect of donor age on clinical outcomes after allo-HSCT, thereby providing higher-quality evidence to optimize donor selection strategies.

Primary outcome measures

  • Overall Survival [Time frame: From the date of transplantation to the date of death from any cause or last follow-up, assessed up to 15 years.]

Eligibility criteria

Inclusion criteria

  • Age 18 years or older.
  • Diagnosis of hematologic malignancy.
  • Underwent first allogeneic hematopoietic stem cell transplantation.
  • HLA matching level of 0.5 or higher.
  • Available donor age information.
  • Available clinical follow-up and outcome data.

Exclusion criteria

  • Previous autologous or allogeneic hematopoietic stem cell transplantation.
  • HLA matching level below 0.5.
  • Missing donor age information.
  • Missing key exposure-defining or outcome-defining data required for the analysis.

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: NCT07666568 · TTE DONOR AGE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗