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.

NCT Number	NCT07666568
Lead Sponsor	The First Affiliated Hospital of Soochow University
Conditions	A Target Trial Emulation Study, Donor Age, ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
Enrollment	5,000 participants
Start Date	2026-07-15
Primary Completion	2026-07-15 (estimated)
Study Completion	2027-12-21 (estimated)
Updated on ClinicalTrials.gov	2026-06-24