EUCTR2017-002697-39-PLActive, not recruitingPhase 1
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 sites32 target enrollmentStarted: March 26, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 32
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Patients who develop a first episode of Grade III or IV aGVHD (= gastrointestinal Stages 2 to 4) with gut predominance if other organs involved (Przepiorka D, 1995), resistant to a first-line therapy with steroids, defined as any of the following:
- •a.Lack of improvement after 5 to 7 days of treatment with CS at 2mg/kg/d methylprednisolone equivalent dose.
- •b.Progression after 3 days of treatment with CS at 2 mg/kg/d methylprednisolone equivalent dose.
- •c.Patients treated with 1 mg/kg/d of CS because the physician deemed they would not tolerate 2 mg/kg/d and who correspond to the definition of SR patients.
- •2.Age = 18 years old
- •3.Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen
- •4.Patients able to have a minimum of 12 hours discontinuation of systemic antibiotics in order to perform the allogeneic FMT (for patients who require antibiotics, using antibiotics that have limited impact on the gut microbiota should be considered in priority. The complete list of recommended and not recommended antibiotics is in Appendix 6)
- •5.Signature of informed and written consent by the subject or by the subject’s legally acceptable representative for patients under guardianship or trusteeship
- •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
Exclusion Criteria
- •1.Grade IV hyper-acute GVHD as defined by the MD Anderson’s criteria (Saliba RM, 2007)
- •2.Late-onset aGVHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
- •3.Overlap chronic GVHD as defined by the NIH Consensus Criteria (Jagasia MH, 2015)
- •4.Acute GVHD after donor lymphocytes infusion (DLI)
- •5.Relapsed/persistent malignancy requiring rapid immune suppression withdrawal
- •6.Active uncontrolled infection according to the attending physician
- •7.Current or past veno-occlusive disease or other uncontrolled complication unless otherwise agreed in writing by the sponsor.
- •8.Systemic drugs other than corticosteroids for GvHD treatment, including extra-corporeal photopheresis (ECP), unless treatments began before or concomitantly with corticosteroid treatment. New therapies after corticosteroids are a definitive non-inclusion criterium.
- •Drugs for GVHD prevention (e.g., calcineurin inhibitors, Mycophenolate mofetil (MMF), ECP…), are allowed as long as treatment began before or concomitantly with the corticosteroid treatment.
- •9.Absolute neutrophil count < 0.5 x 109 /L
- •10.Absolute platelet count < 10 000
- •11.Patient with negative IgG EBV serology
- •12.Current or past evidence of toxic megacolon, bowel obstruction or gastrointestinal perforation on abdominal X-ray
- •13.Known allergy or intolerance to trehalose or maltodextrin
- •14.Vulnerable patients such as: minors, persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention
- •15.Pregnancy: positive urinary or blood test in females of childbearing potential; lactation; absence of effective contraceptive method for females of childbearing potential throughout the entire duration of the study
- •16.Other ongoing interventional protocol that might interfere with the current study’s primary endpoint.
Investigators
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