Hematologic MalignancyB-RECNCT04682314
B-Cell Reconstitution After Hematopoietic Stem Cell Transplantation
An observational study of Hematologic Malignancy, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment for a variety of hematological malignancies. However, patients who have received this treatment have a persistent deficit in humoral immunity up to one year post-transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Jul 2023
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients aged 18 years and older with hematological malignancies and subject to allogeneic HSCT
Who may be able to join
- Patients :
- 18 years of age and older
- with hematological malignancies and subject to allogeneic HSCT
- with health insurance coverage (bénéficiaire ou ayant droit)
- having signed a written informed consent.
- 18 years of age and older
- with health insurance coverage (bénéficiaire ou ayant droit)
- having signed a specific written informed consent.
Who cannot join
- Absence of written informed consent
- Patient or donor on AME
- Patient or donor on AME or under protection by law, tutorship or curatorship
- Pregnant women
Trial locations and contacts
No sites are listed yet.
About this study
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment for a variety of hematological malignancies. However, patients who have received this treatment have a persistent deficit in humoral immunity up to one year post-transplant. To date, the design of new therapeutic strategies to improve immune recovery in allo-HSCT patients is still hampered by the fact that post-transplant regenerative hematopoiesis has never been studied, and more generally by our currently limited knowledge on the development and function of human B lymphocytes. The main objective of our study is to study early B-cell progenitor reconstitution after allogeneic hematopoietic stem cell transplantation.
- Conditions
- Hematologic Malignancy
- Medical subject headings
- Hematologic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
B cells reconstitution
B cell clusters as assess by CyTOF technology
Measured: at day 100 days post-transplant
Secondary outcomes (3)
B cells reconstitution
B cell clusters as assess by CyTOF technology
Measured: at 6 months post-transplant
Perturbations in growth or differentiation of progenitor/precursor of B cells
Perturbations in growth or differentiation of progenitor/precursor of B cells will be assessed by cytometry technology
Measured: at 100 days post transplant
Perturbations in growth or differentiation of progenitor/precursor of B cells
Perturbations in growth or differentiation of progenitor/precursor of B cells will be assessed by cytometry technology
Measured: at 6 months post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study startDec 2020 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682314
- Sponsor's protocol ID
- APHP201015
- Acronym
- B-REC
- Status last verified
- Dec 2020
- First submitted
- 7 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-Cell Reconstitution After Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04682314
- Acronym / sponsor ID
- B-REC / APHP201015
- Conditions
- Hematologic Malignancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 23 Dec 2020 (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.
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative treatment for a variety of hematological malignancies. However, patients who have received this treatment have a persistent deficit in humoral immunity up to one year post-transplant. To date, the design of new therapeutic strategies to improve immune recovery in allo-HSCT patients is still hampered by the fact that post-transplant regenerative hematopoiesis has never been studied, and more generally by our currently limited knowledge on the development and function of human B lymphocytes. The main objective of our study is to study early B-cell progenitor reconstitution after allogeneic hematopoietic stem cell transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 years and older with hematological malignancies and subject to allogeneic HSCT
Key inclusion criteria (8 listed)
- 18 years of age and older
- with hematological malignancies and subject to allogeneic HSCT
- with health insurance coverage (bénéficiaire ou ayant droit)
- having signed a written informed consent.
- 18 years of age and older
Key exclusion criteria (4 listed)
- Absence of written informed consent
- Patient or donor on AME
- Patient or donor on AME or under protection by law, tutorship or curatorship
- Pregnant women
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
B cells reconstitution
Time frame: at day 100 days post-transplant
B cell clusters as assess by CyTOF technology
3 secondary outcomes
B cells reconstitution
Time frame: at 6 months post-transplant
Perturbations in growth or differentiation of progenitor/precursor of B cells
Time frame: at 100 days post transplant
Perturbations in growth or differentiation of progenitor/precursor of B cells
Time frame: at 6 months post-transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancy, run by Assistance Publique - Hôpitaux de Paris.
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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gérard SOCIE (01-42-49-98-24, gerard.socie@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
B cells reconstitution (time frame: at day 100 days post-transplant). 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 23 Dec 2020.