Assessment of Elderly Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Stem Cell Transplant Clinical Trial

— ELDERGRAF  

Official title:

Multi-domain Assessment and Quality of Life in Patients Older Than 60 Years Receiving an Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04375579
• Other study ID #: APHP200084
• Status: Recruiting
• Start date: July 3, 2020
• Est. completion date: July 3, 2024

Study information

• Verified date: April 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marie Robin
• Phone: +33142494724
• Email: marie.robin[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients older than 60 years are more and more transplanted. Comprehensive geriatric assessment (CGA) have been developed and are currently used in patients with cancer, it has been correlated with the prognosis. There is still few data in transplanted patients and the aim of this study is to assess these patients before and after transplantation in order to monitor their general health and quality of life (QOF) and correlate them to the prognostic.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 205
• Est. completion date: July 3, 2024
• Est. primary completion date: July 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 60 years or more at time of transplantation

• Acute leukemia

• Myelodysplastic syndrome

• Myeloproliferative neoplasm

Exclusion Criteria:

• Patient opposed to the protocol

• Vulnerable patients protected by curatorship or administrative supervision

Related Conditions & MeSH terms

• Stem Cell Transplant

Intervention

Other:
• Comprehensive geriatric assessment (CGA)
Questionnaires on nutritional status, autonomy and quality of life

Locations

Country	Name	City	State
France	Dr Marie Robin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		at one year post allogeneic hematopoietic stem cell transplantation
Secondary	Overall survival		at two years post allogeneic hematopoietic stem cell transplantation
Secondary	Morbidity Index		at one year
Secondary	Morbidity Index		at two years
Secondary	Survival without disease and chronic graft-versus-host disease		at one year post allogeneic hematopoietic stem cell transplantation
Secondary	Survival without disease and chronic graft-versus-host disease		at two years post allogeneic hematopoietic stem cell transplantation
Secondary	Proportion of patient with Viral Reactivation	Reactivation of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) virus	at one year
Secondary	Acute graft-versus-host disease		at 100 days
Secondary	Chronic graft-versus-host disease		at 1 year
Secondary	Chronic graft-versus-host disease		at 2 years
Secondary	Incidence of relapse		at two years
Secondary	Walk test	Walk tests measure the functional level of patients suffering from a wide range of cardiac, respiratory, neurological, and musculoskeletal conditions.	at day 100
Secondary	Walk test	Walk tests measure the functional level of patients suffering from a wide range of cardiac, respiratory, neurological, and musculoskeletal conditions.	at one year
Secondary	Walk test	Walk tests measure the functional level of patients suffering from a wide range of cardiac, respiratory, neurological, and musculoskeletal conditions.	at two years
Secondary	Nutritional score	Nutrional score will be assessed using the simple evaluation of food intake (SEFI scale). The minimum value is 0 and the maximum is 10. The highest score mean that the patient's food intake are the same as usual.	at day 100
Secondary	Nutritional score	Nutrional score will be assessed using the simple evaluation of food intake (SEFI scale). The minimum value is 0 and the maximum is 10. The highest score mean that the patient's food intake are the same as usual.	at one year
Secondary	Nutritional score	Nutrional score will be assessed using the simple evaluation of food intake (SEFI scale). The minimum value is 0 and the maximum is 10. The highest score mean that the patient's food intake are the same as usual.	at two years
Secondary	Karnofsky index	The Karnofsky index is a synthetic indicator of the overall health status measuring, on a scale from 0 (death) to 100 (full health)	at day 100
Secondary	Karnofsky index	The Karnofsky index is a synthetic indicator of the overall health status measuring, on a scale from 0 (death) to 100 (full health)	at one year
Secondary	Evaluation of autonomy	Autonomy will be evaluated using ADL and IADL score. Instrumental activities of daily living - global score range from 0 to 4.	at one year
Secondary	Evaluation of Quality of life	Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.; EORTC QLQ-C30 Scoring Manual. Fayers PM et al. on behalf of the EORTC Quality of Life Group. EORTC, 2001. ISBN: 2-9300.	at one year
Secondary	Length of hospitalisation		at two years