Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Horan, Emory University
ClinicalTrials.gov Identifier:
NCT00967096
First received: August 11, 2009
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Malignancy
Bone Marrow Transplantation
Drug: Rifaximin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rifaximin for Preventing Acute Graft Versus Host Disease

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: April 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
The primary clinical endpoint to be assessed in this study will be the proportion of Rifaximin doses successfully administered. Because of mucositis, compliance with oral agents, even those that are well tolerated in other settings, may be limited in the early post-transplant period. Thus, it will be important to demonstrate the feasibility of administering Rifaximin to BMT patients before embarking on larger scale studies. Secondary outcomes will include AGVHD, event-free survival, overall survival, non-relapse mortality, neutrophil and platelet engraftment.
Drug: Rifaximin
Rifaximin for Bone marrow transplant patients

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00967096

Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: John Horan, MD Emory University
  More Information

No publications provided

Responsible Party: John Horan, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00967096     History of Changes
Other Study ID Numbers: IRB00003578, Rifaximin
Study First Received: August 11, 2009
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
rifaximin
acute graft versus host disease
bone marrow transplant
non-malignancy requiring BMT

Additional relevant MeSH terms:
Neoplasms
Graft vs Host Disease
Immune System Diseases
Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 21, 2014