Geriatric Assessment (GA) for Elderly Patients Undergoing Allo-HSCT

Not yet recruiting

• Conditions: Elderly; Geriatric Assessment; ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION

• Registration Number: NCT06946654
• Lead Sponsor: Peking University People's Hospital

Brief Summary

This comprehensive, multidimensional evaluation assesses patient-related factors, disease-related factors, donor-related factors, and treatment-related factors. The study aims to identify potential risk factors influencing transplant outcomes in elderly patients and enhance the outcomes of allo-HSCT.

Detailed Description

This comprehensive, multidimensional evaluation assesses patient-related factors (e.g., age, physical function, and comorbidity index), disease-related factors (e.g., primary diagnosis and blast count), donor-related factors (e.g., donor age, sex, ABO, and type), and treatment-related factors (e.g., conditioning regimen, graft source, and GVHD prophylaxis). The study aims to identify potential risk factors influencing transplant outcomes in elderly patients, establish a comprehensive geriatric assessment model, and guide personalized pre-transplant treatment strategies to reduce transplant-related mortality (TRM). Ultimately, we hope this study could help enhance the outcomes of allogenic hematopoietic stem cell transplantation (allo-HSCT).

Study Timeline

• Study First Submitted: 2025-04-19
• Study First Submitted QC: 2025-04-19
• Study First Posted: 2025-04-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-11
• Study Start: 2025-05-20
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

• (a)Age ≥55 years.
• (b)Hematologic disorders with established indications for transplantation, including malignant and non-malignant hematologic diseases. (c)Willingness to provide informed consent.

Exclusion Criteria

(a)Pregnancy. (b) Uncontrolled active infection. (c) Lack of informed consent. (d)Deemed ineligible for transplantation after investigator assessment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Transplant-related mortality	From HSCT to the follow-up assessment at 12 months post-treatment.	Transplant-related mortality (TRM) is defined as death due to any transplantation-related cause other than disease relapse. Transplant-related mortality will be calculated using a competing risks model.

Secondary Outcome Measures

Name	Time	Method
Engraftment	From HSCT to the follow-up assessment at 12 months post-treatment.	Platelet engraftment was defined as the first of seven consecutive days with a platelet count \>20 × 109/L without transfusion support. Neutrophil engraftment was defined as the first of three consecutive days with an ANC \> 0.5 × 109/L.
GVHD	From HSCT to the follow-up assessment at 12 months post-treatment.	Acute GVHD was classified as symptom presentation before 100 days after haplo-HSCT and chronic GVHD was classified as symptom presentation \>100 days after haplo-HSCT. Each organ (skin, liver, and gut) was staged 1 through 4 for Acute GVHD according to modified criteria based on the schema of the Mount Sinai Acute GVHD International Consortium (MAGIC), and patients were also assigned a grade of acute GVHD (I through IV) based on overall severity. Chronic GVHD was graded in accordance with the National Institutes of Health (NIH) Chronic Graft-versus-Host Disease Consensus Criteria.
Overall Survival	From HSCT to the follow-up assessment at 12 months post-treatment.	The time from haplo-HSCT to death from any cause in patients with AML. Overall survival will be calculated using the Kaplan-Meier method.
Cumulative Incidence of Relapse	From HSCT to the follow-up assessment at 12 months post-treatment.	Relapse was defined as disease recurrence.
Disease-Free Survival	From HSCT to the follow-up assessment at 12 months post-treatment.	Disease-free survival (DFS) was defined as the time from transplantation to relapse, disease progression, or death, whichever occurred first.
Viral Infection	From HSCT to the follow-up assessment at 12 months post-treatment.	Detection of CMV-DNA and EBV-DNA in peripheral blood twice a week.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China