Clinical trial NCT04375579: Assessment of Elderly Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Official title: Multi-domain Assessment and Quality of Life in Patients Older Than 60 Years Receiving an Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Stem Cell Transplant
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 205
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 60 years who received an allogeneic hematopoietic stem cell transplantation HSCT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: at one year post allogeneic hematopoietic stem cell transplantation
Secondary outcomes:
measure: Overall survival
timeFrame: at two years post allogeneic hematopoietic stem cell transplantation
measure: Morbidity Index
timeFrame: at one year
measure: Morbidity Index
timeFrame: at two years
measure: Survival without disease and chronic graft-versus-host disease
timeFrame: at one year post allogeneic hematopoietic stem cell transplantation
measure: Survival without disease and chronic graft-versus-host disease
timeFrame: at two years post allogeneic hematopoietic stem cell transplantation
measure: Proportion of patient with Viral Reactivation
timeFrame: at one year
measure: Acute graft-versus-host disease
timeFrame: at 100 days
measure: Chronic graft-versus-host disease
timeFrame: at 1 year
measure: Chronic graft-versus-host disease
timeFrame: at 2 years
measure: Incidence of relapse
timeFrame: at two years
measure: Walk test
timeFrame: at day 100
measure: Walk test
timeFrame: at one year
measure: Walk test
timeFrame: at two years
measure: Nutritional score
timeFrame: at day 100
measure: Nutritional score
timeFrame: at one year
measure: Nutritional score
timeFrame: at two years
measure: Karnofsky index
timeFrame: at day 100
measure: Karnofsky index
timeFrame: at one year
measure: Evaluation of autonomy
timeFrame: at one year
measure: Evaluation of Quality of life
timeFrame: at one year
measure: Length of hospitalisation initially
timeFrame: at two years
measure: Length of hospitalisation during the first year after graft
timeFrame: Up to one year
measure: Questionnaire completion rate
timeFrame: At 2 years
measure: Length of pre-grafting visit
timeFrame: At 2 years
measure: Length of D100 visit
timeFrame: At 2 years
measure: Length of 1year visit
timeFrame: At 2 years
measure: Length of 2 years visit
timeFrame: At 2 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU Angers
city: Besancon
country: France
facility: CHU Besancon
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Caen
country: France
facility: CHU Caen
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Grenoble
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: CHRU Lille
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: CHU Lyon
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: CHRU Nancy
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Nice
city: Paris
country: France
facility: Hopital de la Pitié Salpetrière
city: Paris
country: France
facility: Hopital Necker
city: Paris
country: France
facility: Hopital Saint Louis
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
References: