Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplant Cyclophosphamide in Patients With Acquired Refractory Aplastic Anemia or in Relapse After Immunosuppression

PHASE2RecruitingINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

January 6, 2022

Primary Completion Date

January 6, 2027

Study Completion Date

January 6, 2027

Conditions
Refractory Idiopathic Aplastic AnemiaHaploidentical Allogeneic Hematopoietic Stem Cell Transplantation
Interventions
OTHER

Allogenic transplantation

"1. Conditioning regimen Fludarabine (30mg/m2/day i.v: day -6 to day -2), pre-transplant cyclophosphamide (14.5 mg/kg/day i.v: day -6 and day -5), and Total Body Irradiation (2 Gray on day-1)~2. Stem cell source Bone Marrow~3. GVHD Prophylaxis Rabbit ATG dosed at 0.5 mg/kg on day -9 and 2 mg/kg on days -8 and -7, Cyclophosphamide 50 mg/Kg/day at D+3 and D+4, Tacrolimus (residual 8-12 microg/L) and mycophenolate (MMF) from D+5. In absence of GvHD, MMF will be stopped at D35 and tacrolimus at day 365.~4. Prevention of EBV reactivation Rituximab 150mg/m2 intravenously at Day+5 post HSCT, Each infusion of Rituximab will be preceded by administration of anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine."

Trial Locations (35)

Unknown

RECRUITING

CHU Amiens, Amiens

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CHU Angers, Angers

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CHU Besancon, Besançon

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CHU Bordeaux, Bordeaux

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Hôpital du Haut-Lévêque, Bordeaux

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CHU Caen, Caen

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Hopital Percy, Clamart

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CHU Clermont, Clermont-Ferrand

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CHU-Estaing_Clermont Ferrand, Clermont-Ferrand

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Henri Mondor, Créteil

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CHU Grenoble, Grenoble

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CHU Lille, Lille

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CHU Lille, Lille

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CHU Limoges, Limoges

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CHU Lyon Sud, Lyon

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IHOP, CHU Lyon, Lyon

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Hopital La Timone, Marseille

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CHU Montpellier, Montpellier

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CHU Montpellier, Montpellier

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CHU Nancy, Nancy

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CHU Nantes, Nantes

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CHU Nantes, Nantes

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CHU Nice, Nice

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Hopital Necker, Paris

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Hopital Robert Debré, Paris

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Hôpital de La Pitié Salpetriere, Paris

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Hôpital Saint Antoine, Paris

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Hôpital Saint Louis, Paris

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CHU Poitiers, Poitiers

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CHU Rennes, Rennes

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CHU Rennes, Rennes

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Crlcc Henri Becquerel Rouen, Rouen

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ICLN_Saint Priest En Jarez, Saint-Priest-en-Jarez

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CHRU Strasbourg, Strasbourg

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CHU Toulouse, Toulouse

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER