Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD)

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.

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Key information

Conditions

Malignancy Bone Marrow Transplantation Neoplasms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Healthcare of Atlanta, Atlanta, Georgia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients must be at least 12 years old.
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.
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

Age under 12 years.
Known hypersensitivity to rifaximin, or other rifamycin antimicrobial agents.
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.
Patients with documented severe active infection (viral, bacterial, fungal, protozoal) will not be eligible.
Patients with treatment unresponsive hematologic malignant diseases (based on an assessment done within two weeks of the start of conditioning therapy).

Treatment and study plan

Rifaximin

Drug

Rifaximin for Bone marrow transplant patients

Primary outcomes

Determine the feasibility of this approach; to gather preliminary data on the incidence of GVHD and other clinical outcomes; to obtain pre-clinical data on the serial plasma levels of three biologic markers- endotoxin, soluble IL-2 receptor and TNF.

Time frame: 1 year after last patient enrolled

Secondary outcomes

Obtain preliminary data on the efficacy of administering rifaximin for prophylaxis against serious bacterial infections in BMT patients.

Time frame: 1 year after last patient enrolled

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Rifaximin for Preventing Acute Graft Versus Host Disease

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Aug 27, 2009
Registry last updated: Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed