Clinical trial NCT06946654: Geriatric Assessment (GA) for Elderly Patients Undergoing Allo-HSCT
Official title: Geriatric Assessment (GA) for Elderly Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation: a Prospective Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Elderly
Geriatric Assessment
ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
Keywords: elderly
Geriatric Assessment
allo-HSCT
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 176
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients with hematologic disorders with established indications for transplantation, including malignant and non-malignant hematologic diseases.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Transplant-related mortality
timeFrame: From HSCT to the follow-up assessment at 12 months post-treatment.
Secondary outcomes:
measure: Engraftment
timeFrame: From HSCT to the follow-up assessment at 12 months post-treatment.
measure: GVHD
timeFrame: From HSCT to the follow-up assessment at 12 months post-treatment.
measure: Overall Survival
timeFrame: From HSCT to the follow-up assessment at 12 months post-treatment.
measure: Cumulative Incidence of Relapse
timeFrame: From HSCT to the follow-up assessment at 12 months post-treatment.
measure: Disease-Free Survival
timeFrame: From HSCT to the follow-up assessment at 12 months post-treatment.
measure: Viral Infection
timeFrame: From HSCT to the follow-up assessment at 12 months post-treatment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
References: