ElderlyGANCT06946654
Geriatric Assessment (GA) for Elderly Patients Undergoing Allo-HSCT
An observational study of Elderly and Geriatric Assessment, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Elderly, Geriatric Assessment, ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
- What is being tested?
- Geriatric Assessment
- Type of treatment
- Surgery or procedure
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Elderly patients with hematologic disorders with established indications for transplantation, including malignant and non-malignant hematologic diseases.
Who may be able to join
- (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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Yuqian Sun, 861088326666, sunyuqian83@hotmail.com
About this study
Official title: 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.
Read the 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).
- Being tested
- Geriatric Assessment
- Keywords
- elderly, Geriatric Assessment, allo-HSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric AssessmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric Assessment | Not described Receives: Procedure: Geriatric Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant-related mortality
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.
Measured: From HSCT to the follow-up assessment at 12 months post-treatment.
Secondary outcomes (6)
Engraftment
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.
Measured: From HSCT to the follow-up assessment at 12 months post-treatment.
GVHD
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.
Measured: From HSCT to the follow-up assessment at 12 months post-treatment.
Overall Survival
The time from haplo-HSCT to death from any cause in patients with AML. Overall survival will be calculated using the Kaplan-Meier method.
Measured: From HSCT to the follow-up assessment at 12 months post-treatment.
Cumulative Incidence of Relapse
Relapse was defined as disease recurrence.
Measured: From HSCT to the follow-up assessment at 12 months post-treatment.
Disease-Free Survival
Disease-free survival (DFS) was defined as the time from transplantation to relapse, disease progression, or death, whichever occurred first.
Measured: From HSCT to the follow-up assessment at 12 months post-treatment.
Viral Infection
Detection of CMV-DNA and EBV-DNA in peripheral blood twice a week.
Measured: From HSCT to the follow-up assessment at 12 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Jan 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Yuqian, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946654
- Sponsor's protocol ID
- 2025PHB131-001
- Acronym
- GA
- Status last verified
- Sep 2026
- First submitted
- 19 Apr 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Assessment (GA) for Elderly Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation: a Prospective Study.
- ClinicalTrials.gov ID
- NCT06946654
- Acronym / sponsor ID
- GA / 2025PHB131-001
- Keywords
- elderly, Geriatric Assessment, allo-HSCT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric Assessment | – | Procedure: Geriatric Assessment |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elderly patients with hematologic disorders with established indications for transplantation, including malignant and non-malignant hematologic diseases.
Key inclusion criteria (3 listed)
- (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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric AssessmentThis 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. | Procedure or surgery | Geriatric Assessment |
Primary outcome
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.
6 secondary outcomes
Engraftment
Time frame: 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.
Overall Survival
Time frame: 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.
Disease-Free Survival
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly and Geriatric Assessment, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqian Sun (861088326666, sunyuqian83@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant-related mortality (time frame: From HSCT to the follow-up assessment at 12 months post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.