A Study of FMT in Patients With AML Allo HSCT in Recipients
NCT ID: NCT03678493
Last Updated: 2024-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2019-09-09
2023-12-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AML Patients undergoing Intensive Chemotherapy
Fecal Microbiota Transplant (FMT)
Oral Capsule
AML Patients undergoing Intensive Chemotherapy Control
Placebo
Oral Capsule
Patients undergoing Allo-HCT Patients
Fecal Microbiota Transplant (FMT)
Oral Capsule
Patients undergoing Allo-HCT Patients Control
Placebo
Oral Capsule
Interventions
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Fecal Microbiota Transplant (FMT)
Oral Capsule
Placebo
Oral Capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Armin Rashidi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota, Division of Hematology, Oncology and Transplantation
Locations
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Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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MT2018-01
Identifier Type: OTHER
Identifier Source: secondary_id
2017LS170
Identifier Type: -
Identifier Source: org_study_id
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