Prospective Interventional Study Exploring the Microbiota Recolonization in SR-GvHD Patients Receiving MaaT013
NCT ID: NCT05017688
Last Updated: 2023-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-10-06
2024-12-31
Brief Summary
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Detailed Description
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The ATUn is indicated to provide a benefit in the treatment of patients with grade III-IV aGVHD:
* In case of initial resistance to CS alone or in association or in case of failure to other treaments
* In first-line therapy in association with CS in case of steroid-dependance (inability to taper CS dose \<0.5 mg/kg/d)
* In case of digestive aGvHD with overlap syndrome The objective of the ORION study is to explore the changes of gut microbiota composition following MaaT013 administration and its impact on the immune system in GVHD patients.
Blood and stool samples will be collected at each visit which explained why the study is thus categorized as research involving the human person with low risks and constraints clinical trial (RIPH2).
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patient population
The population of the study will be adult patients with GI-aGVHD grade III to IV undergoing MaaT013 treatment through named-patient use program ATUn (Early Access Program).
Blood and stool samples will be collected at each visit to analyse the gut microbiota and the immune cells.
Blood and stool sample collection
Collection of blood samples (55 mL) Collection of fecal samples (10g)
Interventions
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Blood and stool sample collection
Collection of blood samples (55 mL) Collection of fecal samples (10g)
Eligibility Criteria
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Inclusion Criteria
* Signature of informed and written consent by the subject or by the subject's legally acceptable representative for patients under guardianship or trusteeship.
* Affiliated or recipient from a social security scheme
Exclusion Criteria
* Vulnerable patients such as: minors, persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention.
18 Years
85 Years
ALL
No
Sponsors
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MaaT Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Sarah Guenounou, MD
Role: PRINCIPAL_INVESTIGATOR
IUCT ONCOPOLE
Locations
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Chu Amiens Picardie Site Sud
Amiens, , France
Chu de Caen
Caen, , France
Chu Grenoble
Grenoble, , France
Chu de Nice - L'Archet 1
Nice, , France
Aphp - Hopital Saint Antoine
Paris, , France
Chu Lyon Sud
Pierre-Bénite, , France
Chu La Miletrie
Poitiers, , France
Chu de Rennes - Hopital Pontchaillou
Rennes, , France
Institut Universitaire Du Cancer de Toulouse - Oncopole
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MPOH07
Identifier Type: -
Identifier Source: org_study_id
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