Allogeneic Stem Cell TransplantationcovidalloNCT05088941
Impact of COVID-19 Pandemic on Allogeneic Stem Cell Transplantation Organization : a French Experience
An observational study of Allogeneic Stem Cell Transplantation and SARS-CoV2 Infection, run by Central Hospital, Nancy, France at 1 site in France.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Allogeneic Stem Cell Transplantation, SARS-CoV2 Infection, COVID-19
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 2 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients (children and adults) having HSCT and treated at the CHRU of NANCY between march march 2020 to may 2021
Who may be able to join
- patients receiving an allogeneic stem cell transplant between march 2020 and may 2021.
Who cannot join
- patients receiving an allogeneic stem cell transplant before march 2020 and after may 2021.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- allogeneic stem cell transplant, SARS-CoV2, freezing process
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
% of Total Nucleated Cell (TNC) yield (final TNC count / initial TNC count)
Measured: 2020-2021
%of CD34 + cells yield (final CD34+ cell count / initial CD34+ cell count)
Measured: 2020-2021
% of CFU-GM yield (final CFU-GM count / initial CFU-GM count)
Measured: 2020-2021
% of post-thaw CD34 viability
Measured: 2020-2021
% of post-thaw TNC viability
Measured: 2020-2021
Secondary outcomes (6)
GvHD incidence
Measured: 2020-2021
infections rate
Measured: 2020-2021
relapse rate
Measured: 2020-2021
death rate
Measured: 2020-2021
graft rejection
Measured: 2020-2021
aplastic recovery
Measured: 2020-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Mar 2020
- Primary completion1 Sep 2021
- Study completion2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DECOT Véronique, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088941
- Sponsor's protocol ID
- 2021PI153
- Acronym
- covidallo
- Status last verified
- Jul 2022
- First submitted
- 15 Oct 2021
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of SARS-CoV-2 Pandemic on Allogeneic Stem Cell Transplantation Organization : a French Experience
- ClinicalTrials.gov ID
- NCT05088941
- Acronym / sponsor ID
- covidallo / 2021PI153
- Keywords
- allogeneic stem cell transplant, SARS-CoV2, freezing process
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients (children and adults) having HSCT and treated at the CHRU of NANCY between march march 2020 to may 2021
Key inclusion criteria (1 listed)
- patients receiving an allogeneic stem cell transplant between march 2020 and may 2021.
Key exclusion criteria (1 listed)
- patients receiving an allogeneic stem cell transplant before march 2020 and after may 2021.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
% of Total Nucleated Cell (TNC) yield (final TNC count / initial TNC count)
Time frame: 2020-2021
%of CD34 + cells yield (final CD34+ cell count / initial CD34+ cell count)
Time frame: 2020-2021
% of CFU-GM yield (final CFU-GM count / initial CFU-GM count)
Time frame: 2020-2021
% of post-thaw CD34 viability
Time frame: 2020-2021
% of post-thaw TNC viability
Time frame: 2020-2021
6 secondary outcomes
GvHD incidence
Time frame: 2020-2021
infections rate
Time frame: 2020-2021
relapse rate
Time frame: 2020-2021
death rate
Time frame: 2020-2021
graft rejection
Time frame: 2020-2021
aplastic recovery
Time frame: 2020-2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogeneic Stem Cell Transplantation and SARS-CoV2 Infection, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of Total Nucleated Cell (TNC) yield (final TNC count / initial TNC count) (time frame: 2020-2021). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.