Assessment of Elderly Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Active, not recruiting

• Conditions: Stem Cell Transplant

• Registration Number: NCT04375579
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-05
• Study Start: 2020-07-03
• Primary Completion: 2023-10-17
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Study Completion: 2024-10-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 205

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	at one year post allogeneic hematopoietic stem cell transplantation

Secondary Outcome Measures

Name	Time	Method
Nutritional score	at two years	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.
Evaluation of Quality of life	at one year	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.
Length of pre-grafting visit	At 2 years
Walk test	at two years	Walk tests measure the functional level of patients suffering from a wide range of cardiac, respiratory, neurological, and musculoskeletal conditions.
Karnofsky index	at one year	The Karnofsky index is a synthetic indicator of the overall health status measuring, on a scale from 0 (death) to 100 (full health)
Overall survival	at two years post allogeneic hematopoietic stem cell transplantation
Survival without disease and chronic graft-versus-host disease	at two years post allogeneic hematopoietic stem cell transplantation
Acute graft-versus-host disease	at 100 days
Length of hospitalisation during the first year after graft	Up to one year
Questionnaire completion rate	At 2 years
Length of 1year visit	At 2 years
Morbidity Index	at two years
Proportion of patient with Viral Reactivation	at one year	Reactivation of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) virus
Incidence of relapse	at two years
Evaluation of autonomy	at one year	Autonomy will be evaluated using ADL and IADL score. Instrumental activities of daily living - global score range from 0 to 4.
Length of D100 visit	At 2 years
Length of 2 years visit	At 2 years
Length of hospitalisation initially	at two years
Chronic graft-versus-host disease	at 2 years

Trial Locations

Locations (18)

CHU Amiens; 🇫🇷 Amiens, France

CHU Angers; 🇫🇷 Angers, France

CHU Besancon; 🇫🇷 Besancon, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

CHU Caen; 🇫🇷 Caen, France

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU Grenoble; 🇫🇷 Grenoble, France

CHRU Lille; 🇫🇷 Lille, France

CHU Limoges; 🇫🇷 Limoges, France

CHU Lyon; 🇫🇷 Lyon, France

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