Assessment of Elderly Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (ELDERGRAF)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stem Cell Transplant
• Intervention / Treatment: Other: Comprehensive geriatric assessment (CGA)

• Study Type: Observational
• Enrollment (Actual): 205

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU Amiens
  • Angers, France
    • CHU Angers
  • Besancon, France
    • CHU Besançon
  • Bordeaux, France
    • CHU Bordeaux
  • Caen, France
    • CHU Caen
  • Clermont-Ferrand, France
    • CHU Clermont-Ferrand
  • Grenoble, France
    • CHU Grenoble
  • Lille, France
    • CHRU Lille
  • Limoges, France
    • CHU Limoges
  • Lyon, France
    • CHU Lyon
  • Montpellier, France
    • CHU Montpellier
  • Nancy, France
    • CHRU Nancy
  • Nantes, France
    • CHU Nantes
  • Nice, France
    • CHU Nice
  • Paris, France
    • Hopital de La Pitie Salpetriere
  • Paris, France
    • Hopital Saint Louis
  • Paris, France
    • Hopital Necker
  • Toulouse, France
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients over 60 years who received an allogeneic hematopoietic stem cell transplantation HSCT

Description

Inclusion Criteria:

• 60 years or more at time of transplantation
• Patient receiving a hematopoietic stem cell allograft for myeloid hemopathy (myeloid acute leukemia, myelodysplastic syndrome, Myeloproliferative neoplasm) or for an Acute lymphoblastic leukemia
• No opposition to participate

Exclusion Criteria:

• Patient opposed to the protocol
• Vulnerable patients protected by curatorship or administrative supervision
• Patients not covered by a social security scheme

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	at one year post allogeneic hematopoietic stem cell transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		at two years post allogeneic hematopoietic stem cell transplantation
Morbidity Index		at one year
Morbidity Index		at two years
Survival without disease and chronic graft-versus-host disease		at one year post allogeneic hematopoietic stem cell transplantation
Survival without disease and chronic graft-versus-host disease		at two years post allogeneic hematopoietic stem cell transplantation
Proportion of patient with Viral Reactivation	Reactivation of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) virus	at one year
Acute graft-versus-host disease		at 100 days
Chronic graft-versus-host disease		at 1 year
Chronic graft-versus-host disease		at 2 years
Incidence of relapse		at two years
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
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
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
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
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
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
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
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
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
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
Length of hospitalisation initially		at two years
Length of hospitalisation during the first year after graft		Up to one year
Questionnaire completion rate		At 2 years
Length of pre-grafting visit		At 2 years
Length of D100 visit		At 2 years
Length of 1year visit		At 2 years
Length of 2 years visit		At 2 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2020
• Primary Completion (Actual): October 17, 2023
• Study Completion (Estimated): October 17, 2024

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: APHP200084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No