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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Geriatric Assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geriatric Assessment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From HSCT to the follow-up assessment at 12 months post-treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From HSCT to the follow-up assessment at 12 months post-treatment. |
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Inclusion Criteria:
Exclusion Criteria: (a)Pregnancy. (b) Uncontrolled active infection. (c) Lack of informed consent. (d)Deemed ineligible for transplantation after investigator assessment
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Elderly patients with hematologic disorders with established indications for transplantation, including malignant and non-malignant hematologic diseases.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuqian Sun | Contact | 861088326666 | sunyuqian83@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D015577 | Geriatric Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
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| 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. |
| 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. | From HSCT to the follow-up assessment at 12 months post-treatment. |
| Cumulative Incidence of Relapse | Relapse was defined as disease recurrence. | 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. | 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. | From HSCT to the follow-up assessment at 12 months post-treatment. |
| D003710 |
| Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |