Trial | NCT02928523  Report issue

Title

PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients
PreventiOn of DYSbioSis Complications With Autologous Fecal Microbiota Transplantation in acutE myEloid Leukemia Patients Undergoing Intensive Treatment: A Feasibility and Safety Study ODYSSEE STUDY

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
The investigators propose to use autologous fecal microbiota transplantation (AFMT) to acute myeloid leukemia (AML) patients treated with intensive chemotherapy and antibiotics in order to restore the balance of their intestinal microbiome and thereby eradicate treatment-induced multidrug resistant bacteria (MDRB), infection-related complications, as well as sequelae to the gastrointestinal tract. Therefore, the investigators propose to perform a single-arm multicentre prospective fecal microbiota transplantation (FMT) trial in AML patients receiving intensive chemotherapy, and who are usually heavily treated with broad-spectrum antibiotics during aplasia that generate a profound status of dysbiosis. For this purpose, at the time of admission and AML diagnosis, patients will be requested to donate stools that will be comprehensively screened, and if deemed appropriate according to protocol criteria, conditioned and stored frozen until future processing and transplantation after aplasia completion.
Study Started
Jun 30
2016
Primary Completion
Aug 31
2017
Study Completion
Jun 20
2018
Last Update
Sep 09
2020

Drug Autologous Fecal Microbiota Transplantation

  • Other names: MaaT011

Autologous Fecal Microbiota Transplantation Experimental

Patients will receive autologous fecal microbiota transplantation (MaaT011- 150 mL rectal enema) - 2 administrations 24 hours apart.

Criteria 

Inclusion Criteria:

Patients ≥ 18 and ≤ 75 years old with de novo diagnosis of AML or high-risk myelodysplastic syndrom for whom intensive induction chemotherapy is anticipated within 10 days after admission
Patients willing to donate stool samples and to follow protocol recommendations
Signature of informed and written consent

Exclusion Criteria:

Acute promyelocytic leukemia (AML-M3)
Known allergy or intolerance to trehalose or maltodextrin
Pregnancy: positive urinary or blood test in female of childbearing potential
Severe disease with a life expectancy < 3 months
Other ongoing interventional protocol that might interfere with the study

Non eligibility for collection of autologous stools upon admission:

Patients refusing to consent
Antibiotherapy at the time of study inclusion ≥ 4 days
Concomitant or previous diagnosis of a significant inflammatory bowel disease (UC, CD) or other progressive digestive disease requesting treatment or further medical exploration
Presence of severe colitis of any etiology at the time of admission or severe digestive disorders (acute or chronic diarrhea) within 3 months preceding inclusion
Patient getting a recent colonoscopy (within 3 months preceding inclusion)
Detection of MDRB, pathogenic bacteria, parasites, norovirus and/or rotavirus during screening of autologous stool collected at baseline
Non eligibility for inoculum transplantation: persistent mucositis, colitis, or haemorrhoids, presence of blood in more than 50% of patient's faeces the week preceding the transplantation
Non feasibility of inoculum procedure: patient refusal; technical or biological mismatch of the inoculum
Absence of effective contraceptive method for female of childbearing potential
Lactation
Inability to give an informed consent
No Results Posted