Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD)

Status:	Recruiting
Conditions:	Cancer, Hematology
Therapuetic Areas:	Hematology, Oncology
Healthy:	No
Age Range:	12 - Any
Updated:	7/16/2013
Start Date:	April 2007
End Date:	April 2018
Contact:	Sindy Midoro
Email:	Sindy.Midoro@choa.org
Phone:	404-785-1441

Rifaximin for Preventing Acute Graft Versus Host Disease

Acute graft versus host disease is a frequent and often life threatening complication of
allogeneic blood and marrow transplantation. The bacteria that normally reside in the
intestine play a critical role in its development. Injury to the lining of the bowel that
results from the high dose chemotherapy or radiation that transplant patients receive during
the week preceding the transplant allows the bacteria to invade the intestines and spread to
nearby lymph nodes. This, in turn, causes inflammation which has been shown to promote
GVHD. Both pre-clinical and clinical research has demonstrated that oral antibiotics can
prevent graft versus host disease by inhibiting these gut bacteria. Rifaximin has several
features that suggest it could be effective in preventing GVHD. Rifaximin prophylaxis might
also provide an added benefit by protecting highly immunocompromised transplant patients
from severe bacterial infections. This pilot trial will allow the investigators to determine
the feasibility of using Rifaximin for prevention of GVHD and infection in patients
undergoing allogeneic blood and marrow transplantation. The preliminary results will be
used to plan a more definitive trial.

Inclusion Criteria:

1. Patients must be at least 12 years old.

2. Patients will be eligible regardless of their type of disease (malignant or
non-malignant), type of donor (HLA matched related, mismatched related or unrelated
donors), type of hematopoietic cell source (unstimulated marrow, cytokine stimulated
marrow, cytokine stimulated peripheral blood or umbilical cord blood), or GVHD
prophylaxis.

3. Patients must receive a myeloablative or moderately intensive reduced intensity (at
least 8 mg/kg oral busulfan (or the equivalent IV dose), or at least 100 mg/m2 of
Melphalan , or at least 100 mg/kg of cyclophosphamide, or at least 500 cGy of TBI)
conditioning regimen.

Exclusion Criteria:

1. Age under 12 years.

2. Known hypersensitivity to rifaximin, or other rifamycin antimicrobial agents.

3. Minimally toxic conditioning regimen (e.g. low dose TBI based). Since these regimens
induce minimal myelosuppression and gut injury, patients receiving them probably
stand little to gain from antibiotic prophylaxis.

4. Patients with documented severe active infection (viral, bacterial, fungal,
protozoal) will not be eligible.

5. Patients with treatment unresponsive hematologic malignant diseases (based on an
assessment done within two weeks of the start of conditioning therapy).

We found this trial at

sites

Emory University

201 Dowman Dr
Atlanta, Georgia 30303

(404) 727-6123