| Title: |
Pooled Fecal Allogenic Microbiotherapy for Refractory Gastrointestinal Acute Graft- Versus -Host Disease : Results from Early Access Program in Europe |
| Authors: |
Malard, Florent; Loschi, Michael; Cluzeau, Thomas; Devillier, Raynier; Legrand, Faezeh; Charbonnier, Amandine; Lebon, Delphine; Huynh, Anne; Borel, Cecile; Méar, Jean-Baptiste; Lhomme, Faustine; Labussière-Wallet, Hélène; Desmier, Déborah; Moya, Niels; Carré, Martin; Cornillon, Jérôme; Camus, Vincent; Ceballos, Patrice; Saraceni, Francesco; Orvain, Corentin; Chantepie, Sylvain; Rudzki, Jakob Daniel; Couturier, Marie-Anne; Chevallier, Patrice; Mediavilla, Clemence; Roth-Guepin, Gabrielle; Beauvais, David; Daguindau, Etienne; Bilger, Karin; Klein, Stefan; Chorao, Pedro; Altmeyer, Sarah; Patriarca, Francesca; Bruelle, Marion; Plantamura, Emilie; Pittari, Gianfranco; Mohty, Mohamad |
| Contributors: |
CHU Saint-Antoine AP-HP; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU); Centre de Recherche Saint-Antoine (CRSA); Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU); Service Hématologie CHU Nice; Centre Hospitalier Universitaire de Nice (CHU Nice); Institut Paoli-Calmettes (IPC); Fédération nationale des Centres de lutte contre le Cancer (FNCLCC); Service d'Hématologie Clinique et Thérapie Cellulaire CHU Amiens; CHU Amiens-Picardie; HEMATIM - Hématopoïèse et immunologie - UR UPJV 4666 (HEMATIM); Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie-Institut National de la Santé et de la Recherche Médicale (INSERM); Service Hématologie - IUCT-Oncopole CHU Toulouse; Pôle Biologie CHU Toulouse; Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Pôle IUCT CHU Toulouse; Centre Hospitalier Universitaire de Toulouse (CHU Toulouse); Service d’Hématologie Clinique Rennes; Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou; Centre Hospitalier Lyon Sud CHU - HCL (CHLS); Hospices Civils de Lyon (HCL); Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers La Milétrie ); CHU de Grenoble-Alpes - Centre Hospitalier Universitaire CHU Grenoble (CHUGA); Centre Hospitalier Universitaire de Saint-Etienne CHU Saint-Etienne (CHU ST-E); Service d'hématologie CRLCC Henri Becquerel; Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel); CHU Montpellier = Montpellier University Hospital; Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier); Azienda Ospedaliero Universitario delle Marche Ancona; Centre de Recherche en Cancérologie et Immunologie Intégrée Nantes-Angers (CRCI2NA); Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE); Nantes Université - pôle Santé; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ); Institut d'Hématologie de Basse-Normandie (IHBN); Université de Caen Normandie (UNICAEN); Normandie Université (NU)-Normandie Université (NU)-CHU Caen Normandie – Centre Hospitalier Universitaire de Caen Normandie (CHU Caen Normandie); Normandie Université (NU)-Centre Régional de Lutte contre le Cancer François Baclesse Caen (UNICANCER/CRLC); Normandie Université (NU)-UNICANCER-UNICANCER; Innsbruck Medical University = Medizinische Universität Innsbruck (IMU); CHRU Brest - Service d'Hématologie (CHU-Brest-Hemato); Centre Hospitalier Régional Universitaire de Brest (CHRU Brest); Centre Hospitalier Universitaire de Nantes = Nantes University Hospital (CHU Nantes); Centre Hospitalier Universitaire de Bordeaux (CHU Bordeaux); Service d'Hématologie CHRU Nancy; Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy); Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille); Hôpital Jean Minjoz Besançon; Institut de Cancérologie de Strasbourg Europe (ICANS); University Hospital Mannheim; Hospital Universitari i Politècnic La Fe = University and Polytechnic Hospital La Fe; Universitätsklinikum des Saarlandes; Azienda Sanitaria Universitaria Friuli Centrale (ASU FC); MaaT Pharma Lyon; the American-Society-of-Hematology (ASH) |
| Source: |
Blood ; 66th Annual Meeting of the American-Society-of-Hematology (ASH) ; https://hal.science/hal-05132897 ; 66th Annual Meeting of the American-Society-of-Hematology (ASH), the American-Society-of-Hematology (ASH), Dec 2024, Orlando (Fla.), United States. pp.4903-4903, ⟨10.1182/blood-2024-201251⟩ |
| Publisher Information: |
CCSD |
| Publication Year: |
2024 |
| Subject Terms: |
[SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology |
| Subject Geographic: |
Orlando (Fla.); United States |
| Description: |
Meeting abstract ; International audience ; Introduction Acute graft-versus-host disease (aGvHD) is a major source of mortality following allogeneic hematopoietic cell transplantation (allo-HCT). Fecal microbiotherapy has shown promising results in several pilot studies in patients with refractory gastrointestinal (GI)-aGvHD. Here we report long-term clinical outcomes of 154 patients diagnosed with refractory GI-GvHD treated with the pooled allogeneic microbiotherapy MaaT013 within an Early Access Program (EAP) in Europe. Patients and methods One hundred and fifty four patients (incl. two pediatric patients aged 12 and 15years) with steroid-refractory (SR) or -dependent (SD) GI-aGvHD (classical n=93, late onset n=16, chronic or overlap syndrome n=25, hyperacute n=20) were treated with MaaT013 as part of the EAP in Europe (France, Germany, Spain, Italy, Austria). These patients had previously failed 1 to 6 systemic aGvHD treatment lines (median 3; 134/152 received ruxolitinib). Most patients had grade III to IV aGvHD (13% grade II, 47% grade III, 40% grade IV). For each patient, a total of 3 MaaT013 administrations were planned every 7 +/- 2 days (median dose administered 3, range 1-3). Each dose comprised 30 g of feces in 150 mL of solution from 4 to 8 healthy donors administered by enema (except for 1 patient by nasogastric tube). Treatment response was calculated among treated patients based on aGvHD grading at day 28 (D28) compared grading at the time of the EAP request. Results At D28, the GI-overall response rate (ORR) was 51%: 46 complete response (CR 30%), 23 very good partial response (VGPR 15%), 9 partial response (PR 6%). GI-ORR was higher in grade II & III GvHD patients compared to grade IV (65% in grade II, 64% in grade III, 30% in grade IV) and higher in SD versus SR (81% versus 45%). ORR considering all organs (n=154) was 49%, including 41 CR, 19 VGPR and 15 PR. At D56, GI-ORR was 44% with 50 CR, 13 VGPR and 3 PR, ORR was 42% with 47 CR, 12 VGPR and 5 PR (n=151). Administration of MaaT013 in ... |
| Document Type: |
conference object |
| Language: |
English |
| DOI: |
10.1182/blood-2024-201251 |
| Availability: |
https://hal.science/hal-05132897; https://doi.org/10.1182/blood-2024-201251 |
| Accession Number: |
edsbas.4673522A |
| Database: |
BASE |