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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT05088941
Collaborator
(none)
89
Enrollment
1
Location
18.1
Actual Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    89 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Impact of SARS-CoV-2 Pandemic on Allogeneic Stem Cell Transplantation Organization : a French Experience
    Actual Study Start Date :
    Mar 1, 2020
    Actual Primary Completion Date :
    Sep 1, 2021
    Actual Study Completion Date :
    Sep 2, 2021

    Outcome Measures

    Primary Outcome Measures

    1. % of Total Nucleated Cell (TNC) yield (final TNC count / initial TNC count) [2020-2021]

    2. %of CD34 + cells yield (final CD34+ cell count / initial CD34+ cell count) [2020-2021]

    3. % of CFU-GM yield (final CFU-GM count / initial CFU-GM count) [2020-2021]

    4. % of post-thaw CD34 viability [2020-2021]

    5. % of post-thaw TNC viability [2020-2021]

    Secondary Outcome Measures

    1. GvHD incidence [2020-2021]

    2. infections rate [2020-2021]

    3. relapse rate [2020-2021]

    4. death rate [2020-2021]

    5. graft rejection [2020-2021]

    6. aplastic recovery [2020-2021]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU of Nancy Vandoeuvre Les Nancy Meurthe-et-Moselle France 54500

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DECOT Véronique, professor, Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT05088941
    Other Study ID Numbers:
    • 2021PI153
    First Posted:
    Oct 22, 2021
    Last Update Posted:
    Jul 22, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by DECOT Véronique, professor, Central Hospital, Nancy, France
    allogeneic stem cell transplant
    SARS-CoV2
    freezing process
    Additional relevant MeSH terms:
    COVID-19

    Study Results

    No Results Posted as of Jul 22, 2022