A Study of FMT in Patients With AML Allo HSCT in Recipients

Phase 2 Completed 100 enrolled Masonic Cancer Center, University of Minnesota

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2019-09-09
Primary completion: 2022-02-11
Completion: 2023-12-04

Outcome

Missed primary endpoint

paper CONCLUSION: In allogeneic HCT recipients and patients with AML, third-party FMT was safe and ameliorated intestinal dysbiosis, but did not decrease infections. PMID 37235836 ↗

paper infection rate ratio, 0.83; 95% CI, 0.48 to 1.42; P = .49). PMID 37235836 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fecal Microbiota Transplant (FMT)	Unknown	—	Oral