Acute Myeloid LeukemiaPhase 2NCT03678493
A Study of FMT in Patients With AML Allo HSCT in Recipients
A Phase 2 study testing Fecal Microbiota Transplant (FMT) in people with Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled clinical trial of Fecal Microbiota Transplant (FMT) in 2 independent cohorts (60 acute myeloid leukemia patients undergoing intensive chemotherapy and 60 Allo-HCT patients). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Allogeneic Hematopoietic Cell Transplantation
- What is being tested?
- Fecal Microbiota Transplant (FMT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 4 Dec 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥ 18 years
- Cohort A: Patients undergoing intensive induction chemotherapy for acute myeloid leukemia (AML; newly diagnosed or relapsed/refractory).
- Any intensive regimen with planned ~4 weeks of inpatient stay
- Cohort B: Allo-HCT patients
- Any allogeneic transplant regimen with planned GVHD prophylaxis containing generic IV Mycophenolate Mofetil (MMF) and tacrolimus (Tac)
- Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control until at least six months post-FMT/placebo
- Voluntary written consent signed before performance of any study-related procedure not part of normal medical care
Who cannot join
- Planned continuation of antibacterial antibiotics after the first neutrophil recovery (ANC > 1,000)
- Patients who are currently receiving or recently received (within 28 days) other investigational agents.
- Pregnant or breast feeding. The FDA has not classified this agent into a specified pregnancy category. Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: A Randomized Placebo-Controlled Clinical Trial of Fecal Microbiota Transplantation in Patients With Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation Recipients
This is a randomized, double-blind, placebo-controlled clinical trial of Fecal Microbiota Transplant (FMT) in 2 independent cohorts (60 acute myeloid leukemia patients undergoing intensive chemotherapy and 60 Allo-HCT patients). Participants in each cohort will be randomized in a 2:1 ratio to receive up to 3 treatments of FMT vs. placebo after each exposure to antibacterial antibiotics until 3 months after randomization.
- Being tested
- Fecal Microbiota Transplant (FMT), Placebo
- Keywords
- AML, Allo-HCT
- 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.
Fecal Microbiota Transplant (FMT)Biological
Also called FMT
Oral Capsule
PlaceboOther
Oral Capsule
| Study group | Role | What they receive |
|---|---|---|
| AML Patients undergoing Intensive Chemotherapy | Experimental | Not described Receives: Biological: Fecal Microbiota Transplant (FMT) |
| AML Patients undergoing Intensive Chemotherapy Control | Placebo comparator | Not described Receives: Other: Placebo |
| Patients undergoing Allo-HCT Patients | Experimental | Not described Receives: Biological: Fecal Microbiota Transplant (FMT) |
| Patients undergoing Allo-HCT Patients Control | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of FMT in AML Patients and Allo-HCT Recipients - Number of Infections
Number of infections infections until 4 months after the first intervention. Monitored each visit through safety assessment.
Measured: 4 Months
Secondary outcomes (7)
FMT Engraftment
Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.
Measured: 2 Weeks after first FMT treatment
FMT Engraftment
Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.
Measured: 4 Weeks after first FMT treatment
Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)
Percentage of Participants with Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV). Monitored each visit through safety assessment. Grade II better, Grade IV worse.
Measured: Day 180 post-HCT, up to 7 months
Number of BSI of Suspected Gut Origin
Number of BSI of suspected gut origin. Monitored each visit through safety assessment.
Measured: 1 week after first FMT treatment
Number of Bacterial Infections
Number of Bacterial Infections. Monitored each visit through safety assessment.
Measured: 4 Months after first FMT treatment
Number of Viral Infections
Number of Viral Infections. Monitored each visit through safety assessment.
Measured: 4 Months after first FMT treatment
Number of Fungal Infections
Number of Fungal Infections. Monitored each visit through safety assessment.
Measured: 4 Months after first FMT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start9 Sep 2019
- Primary completion11 Feb 2022
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armin Rashidi, MD, PhD, Principal investigator, University of Minnesota, Division of Hematology, Oncology and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678493
- Sponsor's protocol ID
- 2017LS170
- Other IDs
- MT2018-01
- Status last verified
- Apr 2024
- First submitted
- 18 Sep 2018
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Rashidi A, Ebadi M, Rehman TU, Elhusseini H, Kazadi D, Halaweish H, Khan MH, Hoeschen A, Cao Q, Luo X, Kabage AJ, Lopez S, Holtan SG, Weisdorf DJ, Khoruts A, Staley C. Randomized Double-Blind Phase II Trial of Fecal Microbiota Transplantation Versus Placebo in Allogeneic Hematopoietic Cell Transplantation and AML. J Clin Oncol. 2023 Dec 1;41(34):5306-5319. doi: 10.1200/JCO.22.02366. Epub 2023 May 26.
PubMed 37235836
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-Controlled Clinical Trial of Fecal Microbiota Transplantation in Patients With Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation Recipients
- ClinicalTrials.gov ID
- NCT03678493
- Acronym / sponsor ID
- 2017LS170
- Keywords
- AML, Allo-HCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled clinical trial of Fecal Microbiota Transplant (FMT) in 2 independent cohorts (60 acute myeloid leukemia patients undergoing intensive chemotherapy and 60 Allo-HCT patients). Participants in each cohort will be randomized in a 2:1 ratio to receive up to 3 treatments of FMT vs. placebo after each exposure to antibacterial antibiotics until 3 months after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AML Patients undergoing Intensive Chemotherapy | Experimental | Biological: Fecal Microbiota Transplant (FMT) |
| AML Patients undergoing Intensive Chemotherapy Control | Placebo comparator | Other: Placebo |
| Patients undergoing Allo-HCT Patients | Experimental | Biological: Fecal Microbiota Transplant (FMT) |
| Patients undergoing Allo-HCT Patients Control | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age≥ 18 years
- Cohort A: Patients undergoing intensive induction chemotherapy for acute myeloid leukemia (AML; newly diagnosed or relapsed/refractory).
- Cohort B: Allo-HCT patients
- Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control until at least six months post-FMT/placebo
- Voluntary written consent signed before performance of any study-related procedure not part of normal medical care
Key exclusion criteria (3 listed)
- Planned continuation of antibacterial antibiotics after the first neutrophil recovery (ANC > 1,000)
- Patients who are currently receiving or recently received (within 28 days) other investigational agents.
- Pregnant or breast feeding. The FDA has not classified this agent into a specified pregnancy category. Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
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 |
|---|---|---|
| Fecal Microbiota Transplant (FMT)Also: FMTOral Capsule | Biological | AML Patients undergoing Intensive Chemotherapy, Patients undergoing Allo-HCT Patients |
| PlaceboOral Capsule | Other | AML Patients undergoing Intensive Chemotherapy Control, Patients undergoing Allo-HCT Patients Control |
Primary outcome
Efficacy of FMT in AML Patients and Allo-HCT Recipients - Number of Infections
Time frame: 4 Months
Number of infections infections until 4 months after the first intervention. Monitored each visit through safety assessment.
7 secondary outcomes
FMT Engraftment
Time frame: 2 Weeks after first FMT treatment
FMT Engraftment
Time frame: 4 Weeks after first FMT treatment
Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV)
Time frame: Day 180 post-HCT, up to 7 months
Number of BSI of Suspected Gut Origin
Time frame: 1 week after first FMT treatment
Number of Bacterial Infections
Time frame: 4 Months after first FMT treatment
Number of Viral Infections
Time frame: 4 Months after first FMT treatment
Number of Fungal Infections
Time frame: 4 Months after first FMT treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37235836Rashidi A, Ebadi M, Rehman TU, Elhusseini H, Kazadi D, Halaweish H, Khan MH, Hoeschen A, Cao Q, Luo X, Kabage AJ, Lopez S, Holtan SG, Weisdorf DJ, Khoruts A, Staley C. Randomized Double-Blind Phase II Trial of Fecal Microbiota Transplantation Versus Placebo in Allogeneic Hematopoietic Cell Transplantation and AML. J Clin Oncol. 2023 Dec 1;41(34):5306-5319. doi: 10.1200/JCO.22.02366. Epub 2023 May 26.
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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.
Armin Rashidi, MD, PhD principal investigator
University of Minnesota, Division of Hematology, Oncology and Transplantation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal Microbiota Transplant (FMT) in people with Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
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 7 inclusion and 3 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 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy of FMT in AML Patients and Allo-HCT Recipients - Number of Infections (time frame: 4 Months). 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 NCT03678493, 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 16 May 2024.