AllograftFIPALLOCNCT03009708
Feasibility Study of Platelet Activation and Inflammatory Response of Platelets in Hematopoietic Stem Cell Allograft Patients Post-transplant: Spontaneously and After Stimulation by an CMV Antigen
A study testing Blood samples in people with Allograft, run by Institut de Cancérologie de la Loire at 1 site in France.
Trial summary
Traditionally known for their role in haemostasis, platelets have also an immune role. Platelets play a key role in immune mediator secretion, and interact with innate and adaptive immune cells, contributing to the fight against pathogens, as viruses. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allograft
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2017to 6 Nov 2017
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who received an allogeneic haematopoietic stem cell transplant for less than 2 months for any indication ;
- Platelets > 20 G / L (Giga per Litre) for at least 7 days without transfusion support ;
- Patients affiliated to a social security scheme.
Who cannot join
- Patients receiving antiplatelet therapy ;
- Major protected or unable to give consent ;
- Pregnant women ;
- Vulnerable persons defined by French legislation.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42 270
About this study
Traditionally known for their role in haemostasis, platelets have also an immune role.
Platelets play a key role in immune mediator secretion, and interact with innate and adaptive immune cells, contributing to the fight against pathogens, as viruses.
Cytomegalovirus (CMV) is responsible of allograft patients' serious infections, because of the induced immune depression. Platelets activation for patients is not determined during the post-graft period, and platelet induced inflammation following a CMV infection is not described.
Read the detailed description
The descriptive present study will determine if platelet activation is altered during the post-graft follow-up (day 30 to 90).
The activation will be studied spontaneously and after simulation by a CMV (Cytomegalovirus) antigen.
The study will also focus on inflammatory response variation, focusing on the cytokines release during the same post-graft follow-up (spontaneously and after CMV antigen stimulation).
This preliminary study could lead to a better understanding of the immune-modulator role of inflammation, controlled by the platelets, particularly in the initiation of the Graft-versus-host disease in this kind of population.
- Conditions
- Allograft
- Being tested
- Blood samples
- Keywords
- Allograft, Cytomegalovirus, Platelets, Hematopoietic stem cells, Graft Versus Host Disease (GVH), Hemostasis, Adaptive immunity, Innate immunity, Post graft follow up
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Two blood tubes will be collected each week during 8 weeks maximum for the present study. Samples will start at day 30 post-graft and finish at day 90 post-graft maximum.
| Study group | Role | What they receive |
|---|---|---|
| Allograft patients | Experimental | Allograft patients followed at the Institut de Cancérologie Lucien Neuwirth perform blood samples during their post graft follow up in the usual practice, weekly. With the present study, two more blood tubes will be collected with the weekly blood samples. Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vitro spontaneous CD62P (P-selectin) expression level
In vitro spontaneous CD62P (P-selectin) expression level will be calculated, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
Measured: 90 Days
In vitro spontaneous CD63 (membrane protein) expression level
In vitro spontaneous CD63 (membrane protein) expression level will be calculated, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
Measured: 90 Days
In vitro CD62P (P-selectin) expression level after a CMV antigen stimulation
In vitro CD62P (P-selectin) expression level will be calculated after a CMV antigen stimulation, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
Measured: 90 Days
In vitro CD63 (membrane protein) expression level after a CMV antigen stimulation
In vitro CD63 (membrane protein) expression level will be calculated after a CMV antigen stimulation, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
Measured: 90 Days
Secondary outcomes (2)
Level of in vitro spontaneous platelet activation
Level of in vitro spontaneous platelet activation for Hematopoietic stem cells allograft patients during their follow up. The level is calculated with PF4 (Recombinant Platelet Factor 4), RANTES (Chemokine (C-C motif) ligand 5), soluble CD40L (CD 40 ligand), MIP1alpha (Macrophage Inflammatory Proteins), sCD62P (soluble p-selectin) spontaneous expression level.
Measured: 90 Days
Level of in vitro platelet activation after a CMV antigen stimulation
Level of in vitro platelet activation after a CMV antigen stimulation for Hematopoietic stem cells allograft patients during their follow up. The level is calculated with PF4 (Recombinant Platelet Factor 4), RANTES (Chemokine (C-C motif) ligand 5), soluble CD40L (CD 40 ligand), MIP1alpha (Macrophage Inflammatory Proteins), sCD62P (soluble p-selectin) expression level.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start21 Mar 2017
- Primary completion12 Sep 2017
- Study completion6 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllograftStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de la Loire
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe sur l'Immunité des Muqueuses et Agents Pathogènes, (GIMAP), Association Stéphanoise Pour la Recherche en Hématologie-Oncologie (ASPHRO)
- Responsible party
- Sponsor
- Investigators
- CORNILLON Jérôme, PhD, Principal investigator, Institut de Cancérologie Lucien Neuwirth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009708
- Sponsor's protocol ID
- 2016-1101
- Other IDs
- 2016-A01833-48
- Acronym
- FIPALLOC
- Status last verified
- May 2018
- First submitted
- 30 Dec 2016
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Platelet Activation and Inflammatory Response of Platelets in Hematopoietic Stem Cell Allograft Patients Post-transplant: Spontaneously and After Stimulation by an CMV Antigen
- ClinicalTrials.gov ID
- NCT03009708
- Acronym / sponsor ID
- FIPALLOC / 2016-1101
- Conditions
- Allograft
- Keywords
- Allograft, Cytomegalovirus, Platelets, Hematopoietic stem cells, Graft Versus Host Disease (GVH), Hemostasis, Adaptive immunity, Innate immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Institut de Cancérologie de la LoireUniversity, hospital or other
- Collaborators
- Groupe sur l'Immunité des Muqueuses et Agents Pathogènes, (GIMAP), Association Stéphanoise Pour la Recherche en Hématologie-Oncologie (ASPHRO)
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 12 Sep 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 4 Jan 2017 (estimated)
- 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.
Traditionally known for their role in haemostasis, platelets have also an immune role.
Platelets play a key role in immune mediator secretion, and interact with innate and adaptive immune cells, contributing to the fight against pathogens, as viruses.
Cytomegalovirus (CMV) is responsible of allograft patients' serious infections, because of the induced immune depression. Platelets activation for patients is not determined during the post-graft period, and platelet induced inflammation following a CMV infection is not described.
Detailed description
The descriptive present study will determine if platelet activation is altered during the post-graft follow-up (day 30 to 90).
The activation will be studied spontaneously and after simulation by a CMV (Cytomegalovirus) antigen.
The study will also focus on inflammatory response variation, focusing on the cytokines release during the same post-graft follow-up (spontaneously and after CMV antigen stimulation).
This preliminary study could lead to a better understanding of the immune-modulator role of inflammation, controlled by the platelets, particularly in the initiation of the Graft-versus-host disease in this kind of population.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allograft patients | Experimental | Other: Blood samplesAllograft patients followed at the Institut de Cancérologie Lucien Neuwirth perform blood samples during their post graft follow up in the usual practice, weekly. With the present study, two more blood tubes will be collected with the weekly blood samples. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who received an allogeneic haematopoietic stem cell transplant for less than 2 months for any indication ;
- Platelets > 20 G / L (Giga per Litre) for at least 7 days without transfusion support ;
- Patients affiliated to a social security scheme.
Key exclusion criteria (4 listed)
- Patients receiving antiplatelet therapy ;
- Major protected or unable to give consent ;
- Pregnant women ;
- Vulnerable persons defined by French legislation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesTwo blood tubes will be collected each week during 8 weeks maximum for the present study. Samples will start at day 30 post-graft and finish at day 90 post-graft maximum. | Other | Allograft patients |
Primary outcome
In vitro spontaneous CD62P (P-selectin) expression level
Time frame: 90 Days
In vitro spontaneous CD62P (P-selectin) expression level will be calculated, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
In vitro spontaneous CD63 (membrane protein) expression level
Time frame: 90 Days
In vitro spontaneous CD63 (membrane protein) expression level will be calculated, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
In vitro CD62P (P-selectin) expression level after a CMV antigen stimulation
Time frame: 90 Days
In vitro CD62P (P-selectin) expression level will be calculated after a CMV antigen stimulation, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
In vitro CD63 (membrane protein) expression level after a CMV antigen stimulation
Time frame: 90 Days
In vitro CD63 (membrane protein) expression level will be calculated after a CMV antigen stimulation, and will reflect platelet activation for Hematopoietic stem cells allograft patients during their follow up.
2 secondary outcomes
Level of in vitro spontaneous platelet activation
Time frame: 90 Days
Level of in vitro platelet activation after a CMV antigen stimulation
Time frame: 90 Days
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 14 May 2018.
- Individual participant dataSharing planned: No
Related trials for Allograft
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RecruitingPhase 1/2
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Not yet recruiting
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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.
CORNILLON Jérôme, PhD principal investigator
Institut de Cancérologie Lucien Neuwirth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Allograft, run by Institut de Cancérologie de la Loire 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 3 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: finished, as of the sponsor's last update on 14 May 2018. 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?
In vitro spontaneous CD62P (P-selectin) expression level (time frame: 90 Days). The study lists 4 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 14 May 2018.