Younger vs. Older Donors in Allo-HSCT: TTE

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

Diagnosis of hematologic malignancy.

Underwent first allogeneic hematopoietic stem cell transplantation.

HLA matching level of 0.5 or higher.

Disqualifiers

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.

Trial population

This study includes adult patients with hematologic malignancies who underwent allogeneic hematopoietic stem cell transplantation at the study center. Eligible patients will be identified from retrospective clinical records and grouped according to donor age recorded at the time of transplantation.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

5,000 Participants
are grouped into 2 trial groups
Group A: Younger Donor Group
Group B: Older Donor Group

Trial outcomes

Primary outcomes

1

Overall Survival

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

Time frame
From the date of transplantation to the date of death from any cause or last follow-up, assessed up to 15 years.

Secondary outcomes

Other outcomes

Sponsors and contacts

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