This randomized phase II trial studies how well vancomycin-polymyxin B works in preventing graft-versus-host disease (GVHD) in children undergoing donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called GVHD). Bacteria in the intestine may increase immune responses against the body’s normal cells. Antibiotics, such as vancomycin-polymyxin B, kill bacteria in the intestines. Giving vancomycin-polymyxin B before donor cell transplant may help prevent GVHD.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02641236.
PRIMARY OBJECTIVES:
I. To describe longitudinal differences in the intestinal microbiota composition between the two randomized treatment arms of hematopoietic stem cell transplant (HSCT) patients and a cohort of healthy sibling donors.
SECONDARY OBJECTIVES:
I. To describe the frequency of diarrhea in the two randomized treatment arms of HSCT patients.
II. To determine the incidence of acute graft-versus host disease (GVHD) and bacteremia during the first 100 days post-transplant within the two randomized treatment arms of HSCT patients.
III. To describe immune reconstitution and to estimate survival and malignant disease relapse at 2 years after study entry in the two randomized treatment arms of HSCT patients.
IV. To describe the practice of gut decontamination at pediatric stem cell transplant centers participating in the Pediatric Bone Marrow Transplant Consortium (PBMTC) in terms of the practice of gut decontamination, the antibiotic regimen used and the incidence of acute GVHD.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive vancomycin-polymyxin B orally (PO) 3 times daily (TID) starting on day -5. Patients undergo allogeneic HSCT on day 0. Vancomycin-polymyxin B treatment continues through neutrophil engraftment, defined as having an absolute neutrophil count >= 500 cells/mm^3 for 3 consecutive days.
ARM B: Patients undergo allogeneic HSCT on day 0.
After completion of study treatment, patients are followed up for 2 years.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorLeslie E. Lehmann