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NCT Number: NCT07666568

Younger vs. Older Donors in Allo-HSCT: TTE

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.

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Key information

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

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

    Overall survival was defined as the interval between hematopoietic stem cell transplantation and death from any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 24, 2026
Registry last updated
Jun 24, 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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