Graft-versus-host Disease Prevention Clinical Trial
Official title:
Randomized Phase II Trial of Total Gut Decontamination Followed by Fecal Microbiota Transplant (FMT), FMT-Alone or Standard of Care for Reduction in Acute Graft-Versus-Host Disease of the Gastrointestinal Tract in Patients Given Broad-Spectrum Antibiotics
This phase II trial studies how well a fecal microbiota transplant with or without total gut decontamination works in preventing graft versus host disease in patients exposed to broad-spectrum antibiotics. Fecal microbiota transplantation is the administration by enema of fecal matter (stool) that includes helpful bacteria from a normal, healthy donor. Total gut decontamination uses antibiotics to remove/reduce the amount of bacteria in the digestive system. It is not yet known if a fecal microbiota transplant with or without total gut decontamination works better in preventing graft versus host disease compared to standard immunosuppressive therapies (therapies that lower the normal function of the immune system).
PRIMARY OBJECTIVES:
I. To estimate the proportion of patients who develop acute graft-versus-host disease (GVHD)
of the gastrointestinal (GI) tract by day 100 post-transplant for patients randomized to the
standard of care, total gut decontamination (TGD) followed by fecal microbiota transplant
(fecal microbiota transplantation [FMT]) and FMT alone arms.
SECONDARY OBJECTIVES:
I. Overall maximum stage of lower GI tract GVHD by day 100 post-transplant. II. Cumulative
incidence of acute GVHD grade II-IV and maximum grade through 6 months.
III. Time to onset of acute GVHD and acute GI GVHD. IV. Incidence of adverse events and
serious adverse events. V. Incidence of bacterial blood stream infections through 6 months.
VI. Hematologic recovery (neutrophils and platelets). VII. Characterization of the intestinal
microbiota at enrollment, pre-FMT / time of engraftment, 2 month post-FMT/ engraftment, onset
of gastrointestinal tract (GIT) GVHD, and at study completion (6 months).
VIII. Relapse-free survival at 6 months post-randomization. IX. Non-relapse mortality at 6
months post-randomization. X. Overall survival (OS) at 6 months post-randomization.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM A (TGD + FMT): Patients receive piperacillin-tazobactam orally (PO) three times daily
(TID) and nystatin PO four times daily (QID) until FMT. Patients undergo stem cell
transplantation on day 0, then undergo FMT via enema over 5-10 minutes within 3 weeks after
transplantation.
ARM B (FMT): Patients undergo stem cell transplantation on day 0, then undergo FMT via enema
over 5-10 minutes within 3 weeks after transplantation.
ARM C (STANDARD THERAPY): Patients receive standard of care.
After completion of study treatment, patients are followed up at 100 days and 6 months.
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