PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients

NCT02928523 | Completed Phase 1 DMC

• 1 other identifier: MPOH02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

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.

Conditions

Leukemia, Myeloid, Acute

Keywords

Autologous Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (2)

• 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

  40 days

• 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

  40 days

Secondary Outcomes (1)

• Definition of a dysbiosis biosignature using combination of biological parameters

  40 days

Study Arms (1)

Autologous Fecal Microbiota Transplantation

EXPERIMENTAL

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

Drug: Autologous Fecal Microbiota Transplantation

Interventions

Autologous Fecal Microbiota Transplantation DRUG

Also known as: MaaT011

Autologous Fecal Microbiota Transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Concomitant or previous diagnosis of a significant inflammatory bowel disease (UC, CD) or other progressive digestive disease requesting treatment or further medical exploration
• 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

Sponsors & Collaborators

• MaaT Pharma: lead

Study Sites (4)

IPC

Marseille, 13009, France

Location

CHU Nantes

Nantes, 44000, France

Location

Hopital Saint Antoine

Paris, 75012, France

Location

HCL Lyon Sud

Pierre-Bénite, 69310, France

Location

Related Publications (1)

• 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.

  PMID: 34035290 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Mohamad Mohty, MD, PhD

  APHP

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: October 10, 2016
• Study Start: June 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: June 20, 2018
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)