Treatment of steroid refractory gastro-intestinal acute graft-versus-Host disEase afteR AllogeneiC hematopoietic stem celL transplantation with fEcal microbiota transfer (HERACLES) - HERACLES

MaaT Pharma0 个研究点目标入组 32 人开始时间: 2018年3月15日最近更新: 2021年4月5日

研究概览

暂无简介。

•-Patients who develop a first episode of Stage 3 or 4 GI-aGVHD with gut predominance (Przepiorka D, 1995), resistant to a first line therapy with steroids (lack of improvement after 5 days or progression after 3 days of treatment with corticosteroids at 2 mg/Kg methylprednisolone equivalent dose) (SR GI-aGVHD)
•-Age = 18 years old
•-Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
•-Patients able to have a minimum of 12 hours discontinuation of systemic antibiotics in order to perform the allogeneic FMT (for patient who received antibiotics MaaT Pharma advises against the use of antibiotics (commonly used) with significant digestive excretion (for example but not limited to: metronidazol, ceftriaxone, levofloxacin))
•-Signature of informed and written consent by the subject or by the subject’s legally acceptable representative
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 7

•-Grade IV hyper-acute GVHD as defined by the MD Anderson’s criteria (Saliba RM, 2007)
•-Late onset aGVHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
•-Overlap chronic GVHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
•-Acute GVHD after donor lymphocytes infusion (DLI)
•-Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
•-Active uncontrolled infection according to the attending physician
•-Other systemic drugs than corticosteroids for GVHD treatment (including extra-corporeal photopheresis). Drugs already being used for GVHD prevention (eg. calcineurin inhibitors) are allowed.
•-Absolute neutrophil count <0.5 x 109 /L
•-Absolute platelet count < 10 000
•-Patient EBV negative
•-Evidence of toxic megacolon or gastrointestinal perforation on abdominal X-ray
•-Known allergy or intolerance to trehalose or maltodextrin or latex
•-Pregnancy: positive urinary or blood test in female of childbearing potential; lactation; absence of effective contraceptive method for female of childbearing potential
•-Other ongoing interventional protocol that might interfere with the current study primary endpoint.

发起方

MaaT Pharma