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| ID | Type | Description | Link |
|---|---|---|---|
| MT2018-01 | Other Identifier | University of Minnesota Masonic Cancer Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AML Patients undergoing Intensive Chemotherapy | Experimental |
| |
| AML Patients undergoing Intensive Chemotherapy Control | Placebo Comparator |
| |
| Patients undergoing Allo-HCT Patients | Experimental |
| |
| Patients undergoing Allo-HCT Patients Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplant (FMT) | Biological | Oral Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 Months |
| Measure | Description | Time Frame |
|---|---|---|
| FMT Engraftment | Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software. | 2 Weeks after first FMT treatment |
| FMT Engraftment |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Armin Rashidi, MD, PhD | University of Minnesota, Division of Hematology, Oncology and Transplantation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37235836 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | AML Patients Undergoing Intensive Chemotherapy | Fecal Microbiota Transplant (FMT): Oral Capsule |
| FG001 | AML Patients Undergoing Intensive Chemotherapy Control | Placebo: Oral Capsule |
| FG002 | Patients Undergoing Allo-HCT | Fecal Microbiota Transplant (FMT): Oral Capsule |
| FG003 | Patients Undergoing Allo-HCT Control | Placebo: Oral Capsule |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AML Patients Undergoing Intensive Chemothera | Fecal Microbiota Transplant (FMT): Oral Capsule |
| BG001 | AML Patients Undergoing Intensive Chemotherapy Control | Placebo: Oral Capsule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | 95% Confidence Interval | Infections | 4 Months |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AML Patients Undergoing Intensive Chemotherapy | Fecal Microbiota Transplant (FMT): Oral Capsule |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloodstream infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bloodstream infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Armin Rashidi, MD, PhD | University of Minnesota, Masonic Cancer Center | (612) 273-8383 | arashidi@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2022 | Oct 24, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 3, 2021 | Oct 24, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Placebo | Other | Oral Capsule |
|
Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software.
| 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. | 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. | 1 week after first FMT treatment |
| Number of Bacterial Infections | Number of Bacterial Infections. Monitored each visit through safety assessment. | 4 Months after first FMT treatment |
| Number of Viral Infections | Number of Viral Infections. Monitored each visit through safety assessment. | 4 Months after first FMT treatment |
| Number of Fungal Infections | Number of Fungal Infections. Monitored each visit through safety assessment. | 4 Months after first FMT treatment |
| BG002 | Patients Undergoing Allo-HCT Patients | Fecal Microbiota Transplant (FMT): Oral Capsule |
| BG003 | Patients Undergoing Allo-HCT Patients Control | Placebo: Oral Capsule |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Fecal Microbiota Transplant (FMT): Oral Capsule |
| OG003 | Patients Undergoing Allo-HCT Control | Placebo: Oral Capsule |
|
|
| Secondary | FMT Engraftment | Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software. | Only a subset of patients were evaluable for engraftment analysis. This is because they either didn't provide a sample or their sample didn't meet the quality criteria. | Posted | Mean | Inter-Quartile Range | Proportion of Donor Microbiome FMT | 2 Weeks after first FMT treatment |
|
|
|
| Secondary | FMT Engraftment | Proportion of Donor Microbiome Fecal Microbiota Transplantation (FMT) Present in Transplant Recipient. Patient and donor samples analyzed with SourceTracker software. | Only a subset of patients were evaluable for engraftment analysis. This is because they either didn't provide a sample or their sample didn't meet the quality criteria. | Posted | Mean | Inter-Quartile Range | Proportion of Donor Microbiome FMT | 4 Weeks after first FMT treatment |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 180 post-HCT, up to 7 months |
|
|
|
| Secondary | Number of BSI of Suspected Gut Origin | Number of BSI of suspected gut origin. Monitored each visit through safety assessment. | Posted | Number | Bloodstream infections | 1 week after first FMT treatment |
|
|
|
| Secondary | Number of Bacterial Infections | Number of Bacterial Infections. Monitored each visit through safety assessment. | Posted | Number | Infections | 4 Months after first FMT treatment |
|
|
|
| Secondary | Number of Viral Infections | Number of Viral Infections. Monitored each visit through safety assessment. | Posted | Number | Infections | 4 Months after first FMT treatment |
|
|
|
| Secondary | Number of Fungal Infections | Number of Fungal Infections. Monitored each visit through safety assessment. | Posted | Number | Infections | 4 Months after first FMT treatment |
|
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|
| 0 |
| 18 |
| 16 |
| 18 |
| 16 |
| 18 |
| EG001 | AML Patients Undergoing Intensive Chemotherapy Control | Placebo: Oral Capsule | 0 | 8 | 4 | 8 | 4 | 8 |
| EG002 | Patients Undergoing Allo-HCT | Fecal Microbiota Transplant (FMT): Oral Capsule | 6 | 49 | 22 | 49 | 22 | 49 |
| EG003 | Patients Undergoing Allo-HCT Control | Placebo: Oral Capsule | 3 | 25 | 4 | 25 | 4 | 25 |
| Acute GVHD | Immune system disorders | Systematic Assessment |
|
| Pneumonia | Immune system disorders | Systematic Assessment |
|
| Fever | Immune system disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Acute GVHD | Immune system disorders | Systematic Assessment |
|
| Pneumonia | Immune system disorders | Systematic Assessment |
|
| Fever | Immune system disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |