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

May 9, 2025 updated by: Sun Yuqian, Peking University People's Hospital

Geriatric Assessment (GA) for Elderly Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation: a Prospective Study.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Elderly patients with hematologic disorders with established indications for transplantation, including malignant and non-malignant hematologic diseases.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Geriatric Assessment
Procedure: Geriatric Assessment
This is a study held in all patients undergoing allogenic hematopoietic stem cell transplantation. Pre-transplant assessment: (1)Patients-related assessment: (a) Age; (b) Functional status (BADL score; IADL score; KPS score; ECOG PS score); (c) Comorbidities (HCT-CI score); (d) Nutritional Status (Body weight; BMI; NRS-2002; MNA-SF; MUST); (e) Psychological Status (SF36-MCS; GDS; PHQ-9; GAD-7); (f) Cognitive Function (MMSE; BMOC); (g) Social Support Level (MOS-SSS; MSPSS); (h) Total Number of Medications Used. (2) Disease-Related Factors Assessment: Primary Disease Diagnosis; ELN Risk Stratification (assessed only for AML patients); Disease Status. (3) Donor-Related Factors Assessment: Donor Age; Donor Sex; Donor-Recipient Blood Type Compatibility; Donor Type; DSA. (4) Treatment-Related Factors Assessment: Conditioning Regimen; GVHD Prophylaxis Regimen; Graft Type.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transplant-related mortality
Time Frame: 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.
From HSCT to the follow-up assessment at 12 months post-treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engraftment
Time Frame: 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.
From HSCT to the follow-up assessment at 12 months post-treatment.
GVHD
Time Frame: 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.
From HSCT to the follow-up assessment at 12 months post-treatment.
Overall Survival
Time Frame: 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.
From HSCT to the follow-up assessment at 12 months post-treatment.
Cumulative Incidence of Relapse
Time Frame: From HSCT to the follow-up assessment at 12 months post-treatment.
Relapse was defined as disease recurrence.
From HSCT to the follow-up assessment at 12 months post-treatment.
Disease-Free Survival
Time Frame: 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.
From HSCT to the follow-up assessment at 12 months post-treatment.
Viral Infection
Time Frame: 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.
From HSCT to the follow-up assessment at 12 months post-treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 20, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

April 19, 2025

First Submitted That Met QC Criteria

April 19, 2025

First Posted (Actual)

April 27, 2025

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 9, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2025PHB131-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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