ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, Elderly, Geriatric Assessment
Conditions
Keywords
elderly, Geriatric Assessment, allo-HSCT
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).
Interventions
PROCEDUREGeriatric 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.
Sponsors
Peking University People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
CONTACTYuqian Sun
Outcome results
None listed