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HERACLES

AcronymISRCTNEudraCTClinicaltrials.govDRKS
MPOH032017-002697-39

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

Status: Active

Purpose / Objectives

Primary Outcome

 Complete response (CR):

• GVHD CR is complete resolution of all signs and symptoms of acute GVHD in all organs without intervening salvage.

• GI CR is defined as: - Able to eat, not requiring parenteral nutrition, and

  • Passing primarily formed stools

Very Good Partial Response (VGPR):

A GVHD VGPR is defined as follows (Martin PJ B. C., 2009):

• Skin: no rash or residual erythematous rash involving < 25% of the body surface, without bullae (residual faint erythema and hyperpigmentation do not count)

• Liver: total serum bilirubin concentration < 2 mg/dL or < 25% of baseline at enrollment

• Gut: tolerating food or enteral feeding, predominantly formed stools1, no overt GI bleeding or abdominal cramping and no more than occasional nausea or vomiting

Secondary Outcomes

Evaluation of FMT safety in patients with SR-GI-aGVHD

• The overall safety of the study will be evaluated with the incidence of all AEs and SAEs (frequency, grade, relationship) throughout the study period.

Diagnosis

Patient attributes

Age

18-99

Inclusion criteria

 

  • Patients who develop a first episode of Stage 3 or 4 GI-aGVHD with gut predominance if involvement of other organs (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)

  • 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 to perform FMT (for patients who received antibiotics, MaaT Pharma advises against the use of antibiotics (commonly used) with significant digestive excretion (for example but not limited to: metronidazole, tazocillin, ceftriaxone, levofloxacin))
  • •Signature of informed and written consent by the subject or by the subject’s legally acceptable representative

Exclusion criteria

  • 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
  • Other systemic drugs than corticosteroids for GVHD treatment (including extra-corporeal photopheresis). Drugs for GVHD prevention (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.

Trial design

  • Phase IIa
  • Multicenter
  • One-arm
  • Open Label

Intervention

Each bag of MaaT013 contains:

  • Active substance: 30g of faecal material from selected healthy donors and consisting of filtered undigested material, microbial populations and their metabolites
  • Cryopreservative diluent allowing the preservation of bacteria during storage (to 150 mL of final product).

Fecal microbiota transfer is performed by a rectal cannula introduced in the patient’s rectum on Day 2, Day 9 and Day 16

 

 

Documents (password protected)

Responsibilities in overall trial

Study Sites

Klinik I für Innere Medizin

Study office

Status

Active

Principal Investigator

Prof. Dr. med. Maria J.G.T. Vehreschild (geb. Rüping)

Deputy of Principal Investigator

  • Prof. Dr. med. Dr. h. c. Christoph Scheid

Subinvestigator

  • Dr. med. Lena M. Biehl
  • Marta Rebeca Cruz Aguilar
  • Jannik Stemler

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