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PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients (ODYSSEE)

Primary Purpose

Leukemia, Myeloid, Acute

Status

Completed

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

Autologous Fecal Microbiota Transplantation

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring Autologous Fecal Microbiota Transplantation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

IPC
CHU Nantes
Hopital Saint Antoine
HCL Lyon Sud

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous Fecal Microbiota Transplantation

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation of AFMT efficacy in dysbiosis correction by measure of microbiota diversity

Comparison of Alpha and Beta diversity indexes at baseline, after chemotherapy and after AFMT will be performed

Evaluation of AFMT efficacy in MDRB eradication based on bacterial culture

MDRB carriage and resistome will be compared at baseline, after chemotherapy and after AFMT

Secondary Outcome Measures

Definition of a dysbiosis biosignature using combination of biological parameters

Microbiota sequencing results will be correlated with immune parameters

Full Information

NCT ID

NCT02928523

First Posted

May 26, 2016

Last Updated

September 4, 2020

Sponsor

MaaT Pharma

1. Study Identification

Unique Protocol Identification Number

NCT02928523

Brief Title

PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients

Acronym

ODYSSEE

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 Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

June 2016 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

June 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MaaT Pharma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Myeloid, Acute

Keywords

Autologous Fecal Microbiota Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Autologous Fecal Microbiota Transplantation

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Autologous Fecal Microbiota Transplantation

Other Intervention Name(s)

MaaT011

Primary Outcome Measure Information:

Title

Evaluation of AFMT efficacy in dysbiosis correction by measure of microbiota diversity

Description

Comparison of Alpha and Beta diversity indexes at baseline, after chemotherapy and after AFMT will be performed

Time Frame

40 days

Title

Evaluation of AFMT efficacy in MDRB eradication based on bacterial culture

Description

MDRB carriage and resistome will be compared at baseline, after chemotherapy and after AFMT

Time Frame

40 days

Secondary Outcome Measure Information:

Title

Definition of a dysbiosis biosignature using combination of biological parameters

Description

Microbiota sequencing results will be correlated with immune parameters

Time Frame

40 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamad Mohty, MD, PhD

Organizational Affiliation

APHP

Official's Role

Study Chair

Facility Information:

Facility Name

IPC

City

Marseille

ZIP/Postal Code

13009

Country

France

Facility Name

CHU Nantes

City

Nantes

ZIP/Postal Code

44000

Country

France

Facility Name

Hopital Saint Antoine

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

HCL Lyon Sud

City

Pierre Benite

ZIP/Postal Code

69310

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34035290

Citation

Malard F, Vekhoff A, Lapusan S, Isnard F, D'incan-Corda E, Rey J, Saillard C, Thomas X, Ducastelle-Lepretre S, Paubelle E, Larcher MV, Rocher C, Recher C, Tavitian S, Bertoli S, Michallet AS, Gilis L, Peterlin P, Chevallier P, Nguyen S, Plantamura E, Boucinha L, Gasc C, Michallet M, Dore J, Legrand O, Mohty M. Gut microbiota diversity after autologous fecal microbiota transfer in acute myeloid leukemia patients. Nat Commun. 2021 May 25;12(1):3084. doi: 10.1038/s41467-021-23376-6.

Results Reference

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PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients

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