ELDERGRAF: Assessment of Elderly Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Recruiting
CT.gov ID
NCT04375579
Collaborator
(none)
205
1
48
4.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Comprehensive geriatric assessment (CGA)

Study Design

Study Type:
Observational
Anticipated Enrollment :
205 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multi-domain Assessment and Quality of Life in Patients Older Than 60 Years Receiving an Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Actual Study Start Date :
Jul 3, 2020
Anticipated Primary Completion Date :
Jul 3, 2023
Anticipated Study Completion Date :
Jul 3, 2024

Outcome Measures

Primary Outcome Measures

  1. Overall survival [at one year post allogeneic hematopoietic stem cell transplantation]

Secondary Outcome Measures

  1. Overall survival [at two years post allogeneic hematopoietic stem cell transplantation]

  2. Morbidity Index [at one year]

  3. Morbidity Index [at two years]

  4. Survival without disease and chronic graft-versus-host disease [at one year post allogeneic hematopoietic stem cell transplantation]

  5. Survival without disease and chronic graft-versus-host disease [at two years post allogeneic hematopoietic stem cell transplantation]

  6. Proportion of patient with Viral Reactivation [at one year]

    Reactivation of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) virus

  7. Acute graft-versus-host disease [at 100 days]

  8. Chronic graft-versus-host disease [at 1 year]

  9. Chronic graft-versus-host disease [at 2 years]

  10. Incidence of relapse [at two years]

  11. Walk test [at day 100]

    Walk tests measure the functional level of patients suffering from a wide range of cardiac, respiratory, neurological, and musculoskeletal conditions.

  12. Walk test [at one year]

    Walk tests measure the functional level of patients suffering from a wide range of cardiac, respiratory, neurological, and musculoskeletal conditions.

  13. 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.

  14. Nutritional score [at day 100]

    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.

  15. Nutritional score [at one year]

    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.

  16. 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.

  17. Karnofsky index [at day 100]

    The Karnofsky index is a synthetic indicator of the overall health status measuring, on a scale from 0 (death) to 100 (full health)

  18. 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)

  19. 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.

  20. 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.

  21. Length of hospitalisation [at two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dr Marie Robin Paris France

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT04375579
Other Study ID Numbers:
  • APHP200084
First Posted:
May 5, 2020
Last Update Posted:
Aug 19, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 19, 2020