Phase 2
Completed N=100
A Study of FMT in Patients With AML Allo HSCT in Recipients
Acute Myeloid Leukemia · Allogeneic Hematopoietic Cell Transplantation
Source: ClinicalTrials.gov NCT03678493 ↗
Enrolled (actual)
100
Serious AEs
46.0%
Results posted
May 2024
Primary outcomePrimary: Efficacy of FMT in AML Patients and Allo-HCT Recipients - Number of Infections — 1.12; 1.50; 0.89; 1.09 Infections
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). 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of FMT in AML Patients and Allo-HCT Recipients - Number of Infections |
1.12; 1.50; 0.89; 1.09 | — |
| SECONDARY FMT Engraftment |
0.4767; 0.2626 | — |
| SECONDARY Percentage of Participants With Grade II-IV Acute Graft-versus-host Disease (aGVHD II-IV) |
29.8; 8 | — |
| SECONDARY Number of BSI of Suspected Gut Origin |
0; 0; 1; 0 | — |
| SECONDARY Number of Bacterial Infections |
8; 2; 10; 2 | — |
| SECONDARY Number of Viral Infections |
2; 2; 13; 8 | — |
| SECONDARY Number of Fungal Infections |
0; 0; 1; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03678493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.