Impact of COVID-19 Pandemic on Allogeneic Stem Cell Transplantation Organization : a French Experience
covidallo
Impact of SARS-CoV-2 Pandemic on Allogeneic Stem Cell Transplantation Organization : a French Experience
1 other identifier
observational
89
1 country
1
Brief Summary
the SARS-CoV2 pandemic has led to a major reorganization of the French Hematology and stem cell transplant departments since march 2020. Since the allogeneic stem cell transplant cannot be delayed especially when patients with hematological malignancies are in a fragile remission, risking relapse at any time, the necessity to maintain safe hematopoietic stem cell (HSC) donations from match unrelated or family donors appears rapidly mandatory during the pandemic period. To increase the safety of voluntary donations, a SARS-CoV2 Polymerase Chain Reaction test has been recommended to donors by regulatory agencies. However, due to the lack of homogeneity of care at European level, some countries do not require SARS-CoV-2 testing in asymptomatic donors. In this case, the test is performed on additional EDTA tube accompanying the graft on arrival or in the case of a missing tube (not collected or forgotten), on few milliliters of the HSC graft. This circuit had the consequence of forcing the clinicians to wait for the test result before starting the patient's conditioning regimen. The graft being already collected and received at the transplant center, and the conditioning regimen lasting on an average of 5 days, this resulted in its conservation during this minimum period and therefore its freezing by the associated cell therapy unit. However, this practice has so far been exceptional regarding allogeneic transplants, which are primarily freshly infused to ensure to the recipient the highest viability and functionality of stem cells. Since the entire freezing-thawing and washing process may impact cell viability and delay the patient's aplastic recovery, this study aimed to analyze the results of one year of allogeneic transplants infused after freezing in terms of graft quality after thawing and clinical consequences.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 2, 2021
CompletedFirst Submitted
Initial submission to the registry
October 15, 2021
CompletedFirst Posted
Study publicly available on registry
October 22, 2021
CompletedJuly 22, 2022
July 1, 2022
1.5 years
October 15, 2021
July 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
% of Total Nucleated Cell (TNC) yield (final TNC count / initial TNC count)
2020-2021
%of CD34 + cells yield (final CD34+ cell count / initial CD34+ cell count)
2020-2021
% of CFU-GM yield (final CFU-GM count / initial CFU-GM count)
2020-2021
% of post-thaw CD34 viability
2020-2021
% of post-thaw TNC viability
2020-2021
Secondary Outcomes (6)
GvHD incidence
2020-2021
infections rate
2020-2021
relapse rate
2020-2021
death rate
2020-2021
graft rejection
2020-2021
- +1 more secondary outcomes
Eligibility Criteria
Patients (children and adults) having HSCT and treated at the CHRU of NANCY between march march 2020 to may 2021
You may qualify if:
- patients receiving an allogeneic stem cell transplant between march 2020 and may 2021.
You may not qualify if:
- patients receiving an allogeneic stem cell transplant before march 2020 and after may 2021.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU of Nancy
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
October 15, 2021
First Posted
October 22, 2021
Study Start
March 1, 2020
Primary Completion
September 1, 2021
Study Completion
September 2, 2021
Last Updated
July 22, 2022
Record last verified: 2022-07