Geriatric Assessment (GA) for Elderly Patients Undergoing Allo-HSCT
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55+
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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.
Disqualifiers
None
Trial population
Elderly patients with hematologic disorders with established indications for transplantation, including malignant and non-malignant hematologic diseases.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Geriatric Assessment
Procedure/SurgeryThis 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.
Treatment groups
176 Participants
are divided into 1 treatment groupGroup A: Geriatric Assessment1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From HSCT to the follow-up assessment at 12 months post-treatment.Secondary outcomes
1
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.
Time frame
From HSCT to the follow-up assessment at 12 months post-treatment.2
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.
Time frame
From HSCT to the follow-up assessment at 12 months post-treatment.3
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.
Time frame
From HSCT to the follow-up assessment at 12 months post-treatment.4
Cumulative Incidence of Relapse
Relapse was defined as disease recurrence.
Time frame
From HSCT to the follow-up assessment at 12 months post-treatment.Sponsors and contacts
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Source ClinicalTrials.gov