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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• France
  • Meurthe-et-Moselle
    • Vandoeuvre Les Nancy, Meurthe-et-Moselle, France, 54500
      • CHRU of Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients (children and adults) having HSCT and treated at the CHRU of NANCY between march march 2020 to may 2021

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
% 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 Outcome Measures

Outcome Measure	Time Frame
GvHD incidence	2020-2021
infections rate	2020-2021
relapse rate	2020-2021
death rate	2020-2021
graft rejection	2020-2021
aplastic recovery	2020-2021

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 2, 2021

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV2; allogeneic stem cell transplant; freezing process
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2021PI153

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No