Impact of COVID-19 Pandemic on Allogeneic Stem Cell Transplantation Organization : a French Experience

Completed

• Conditions: Allogeneic Stem Cell Transplantation; SARS-CoV2 Infection; COVID-19

• Registration Number: NCT05088941
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-02
• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-22
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• patients receiving an allogeneic stem cell transplant between march 2020 and may 2021.

Exclusion Criteria

• patients receiving an allogeneic stem cell transplant before march 2020 and after may 2021.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% of Total Nucleated Cell (TNC) yield (final TNC count / initial TNC count)	2020-2021
% of CFU-GM yield (final CFU-GM count / initial CFU-GM count)	2020-2021
% of post-thaw TNC viability	2020-2021
%of CD34 + cells yield (final CD34+ cell count / initial CD34+ cell count)	2020-2021
% of post-thaw CD34 viability	2020-2021

Secondary Outcome Measures

Name	Time	Method
GvHD incidence	2020-2021
death rate	2020-2021
graft rejection	2020-2021
infections rate	2020-2021
relapse rate	2020-2021
aplastic recovery	2020-2021

Trial Locations

Locations (1)

CHRU of Nancy; 🇫🇷 Vandoeuvre Les Nancy, Meurthe-et-Moselle, France