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Trial record 1 of 1 for:    NCT02928523
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PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients (ODYSSEE)

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ClinicalTrials.gov Identifier: NCT02928523
Recruitment Status : Completed
First Posted : October 10, 2016
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
MaaT Pharma

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: Autologous Fecal Microbiota Transplantation Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PreventiOn of DYSbioSis Complications With Autologous Fecal Microbiota Transplantation in acutE myEloid Leukemia Patients Undergoing Intensive Treatment: A Feasibility and Safety Study ODYSSEE STUDY
Study Start Date : June 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : June 20, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Autologous Fecal Microbiota Transplantation
Patients will receive autologous fecal microbiota transplantation (MaaT011- 150 mL rectal enema) - 2 administrations 24 hours apart.
 Drug: Autologous Fecal Microbiota Transplantation
Other Name: MaaT011


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of AFMT efficacy in dysbiosis correction by measure of microbiota diversity [ Time Frame: 40 days ]
    Comparison of Alpha and Beta diversity indexes at baseline, after chemotherapy and after AFMT will be performed

  2. Evaluation of AFMT efficacy in MDRB eradication based on bacterial culture [ Time Frame: 40 days ]
    MDRB carriage and resistome will be compared at baseline, after chemotherapy and after AFMT


Secondary Outcome Measures :
  1. Definition of a dysbiosis biosignature using combination of biological parameters [ Time Frame: 40 days ]
    Microbiota sequencing results will be correlated with immune parameters


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928523


Locations
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France
IPC
Marseille, France, 13009
CHU Nantes
Nantes, France, 44000
Hopital Saint Antoine
Paris, France, 75012
HCL Lyon Sud
Pierre Benite, France, 69310
Sponsors and Collaborators
MaaT Pharma
Investigators
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Study Chair: Mohamad Mohty, MD, PhD APHP
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MaaT Pharma
ClinicalTrials.gov Identifier: NCT02928523    
Other Study ID Numbers: MPOH02
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by MaaT Pharma:
Autologous Fecal Microbiota Transplantation
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Dysbiosis
 Neoplasms by Histologic Type
Neoplasms
Pathologic Processes