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

COVID-19 Clinical Trial

— covidallo  

Official title:

Impact of SARS-CoV-2 Pandemic on Allogeneic Stem Cell Transplantation Organization : a French Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05088941
• Other study ID #: 2021PI153
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: September 2, 2021

Study information

• Verified date: July 2022
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: September 2, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Allogeneic Stem Cell Transplantation
• COVID-19
• SARS-CoV2 Infection

Locations

Country	Name	City	State
France	CHRU of Nancy	Vandoeuvre Les Nancy	Meurthe-et-Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of Total Nucleated Cell (TNC) yield (final TNC count / initial TNC count)		2020-2021
Primary	%of CD34 + cells yield (final CD34+ cell count / initial CD34+ cell count)		2020-2021
Primary	% of CFU-GM yield (final CFU-GM count / initial CFU-GM count)		2020-2021
Primary	% of post-thaw CD34 viability		2020-2021
Primary	% of post-thaw TNC viability		2020-2021
Secondary	GvHD incidence		2020-2021
Secondary	infections rate		2020-2021
Secondary	relapse rate		2020-2021
Secondary	death rate		2020-2021
Secondary	graft rejection		2020-2021
Secondary	aplastic recovery		2020-2021