Acute Myeloid Leukemia Clinical Trial
Official title:
A Randomized Placebo-Controlled Clinical Trial of Fecal Microbiota Transplantation in Patients With Acute Myeloid Leukemia and Allogeneic Hematopoietic Cell Transplantation Recipients
Verified date | September 2023 |
Source | Masonic Cancer Center, University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 119 |
Est. completion date | January 4, 2025 |
Est. primary completion date | February 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Masonic Cancer Center, University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of FMT in AML patients and allo-HCT recipients - Incidence of infections | Incidence of infections infections until 4 months after the first intervention | 4 Months | |
Secondary | Rate of FMT Engraftment | Rate of FMT Engraftment | 2 Weeks post-FMT | |
Secondary | Rate of FMT Engraftment | Rate of FMT Engraftment | 4 Weeks post-FMT | |
Secondary | Incidence of acute grade II-IV GVHD | Allo-HCT cohort: incidence of acute grade II-IV GVHD | Day 180 post-HCT | |
Secondary | Incidence of BSI of suspected gut origin | Incidence of BSI of suspected gut origin | 1 week post-FMT | |
Secondary | Incidence of Bacterial Infections | Incidence of Bacterial Infections | 4 Months post-intervention | |
Secondary | Incidence of Viral Infections | Incidence of Viral Infections | 4 Months post-intervention | |
Secondary | Incidence of Fungal Infections | Incidence of Fungal Infections | 4 Months post-intervention |
Status | Clinical Trial | Phase | |
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