Leukemia, Myeloid, AcutePhase 1/2ODYSSEENCT02928523
PreventiOn of DYSbioSis Complications With Autologous FMT in AML Patients
A Phase 1/2 study testing Autologous Fecal Microbiota Transplantation in people with Leukemia, Myeloid, Acute, run by MaaT Pharma at 4 sites in France.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Leukemia, Myeloid, Acute
- What is being tested?
- Autologous Fecal Microbiota Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesFrance
- Study dates
- Jun 2016to 20 Jun 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
IPC
Marseille, 13009
CHU Nantes
Nantes, 44000
Hopital Saint Antoine
Paris, 75012
HCL Lyon Sud
Pierre-Bénite, 69310
About this study
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
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
- Being tested
- Autologous Fecal Microbiota Transplantation
- Keywords
- Autologous Fecal Microbiota Transplantation
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Fecal Microbiota TransplantationDrug
Also called MaaT011
| Study group | Role | What they receive |
|---|---|---|
| Autologous Fecal Microbiota Transplantation | Experimental | Patients will receive autologous fecal microbiota transplantation (MaaT011- 150 mL rectal enema) - 2 administrations 24 hours apart. Receives: Drug: Autologous Fecal Microbiota Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 40 days
Secondary outcomes (1)
Definition of a dysbiosis biosignature using combination of biological parameters
Microbiota sequencing results will be correlated with immune parameters
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2017
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaaT Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohamad Mohty, MD, PhD, Study chair, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928523
- Sponsor's protocol ID
- MPOH02
- Acronym
- ODYSSEE
- Status last verified
- Sep 2020
- First submitted
- 26 May 2016
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34035290
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02928523
- Acronym / sponsor ID
- ODYSSEE / MPOH02
- Conditions
- Leukemia, Myeloid, Acute
- Keywords
- Autologous Fecal Microbiota Transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- MaaT PharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Fecal Microbiota Transplantation | Experimental | Drug: Autologous Fecal Microbiota TransplantationPatients will receive autologous fecal microbiota transplantation (MaaT011- 150 mL rectal enema) - 2 administrations 24 hours apart. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Fecal Microbiota TransplantationAlso: MaaT011 | Drug | Autologous Fecal Microbiota Transplantation |
Primary outcome
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
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
1 secondary outcome
Definition of a dysbiosis biosignature using combination of biological parameters
Time frame: 40 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Derived from this study: PubMed 34035290Malard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamad Mohty, MD, PhD study chair
APHP
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous Fecal Microbiota Transplantation in people with Leukemia, Myeloid, Acute, run by MaaT Pharma at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of AFMT efficacy in dysbiosis correction by measure of microbiota diversity (time frame: 40 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02928523, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.