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Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD)

Primary Purpose

Malignancy, Bone Marrow Transplantation

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Rifaximin

About this trial

This is an interventional treatment trial for Malignancy focused on measuring rifaximin, acute graft versus host disease, bone marrow transplant, non-malignancy requiring BMT

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Children's Healthcare of Atlanta
Emory University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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.

Outcomes

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00967096

First Posted

August 11, 2009

Last Updated

November 26, 2013

Sponsor

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT00967096

Brief Title

Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD)

Official Title

Rifaximin for Preventing Acute Graft Versus Host Disease

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignancy, Bone Marrow Transplantation

Keywords

rifaximin, acute graft versus host disease, bone marrow transplant, non-malignancy requiring BMT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Rifaximin

Intervention Description

Rifaximin for Bone marrow transplant patients

Primary Outcome Measure Information:

Title

Time Frame

1 year after last patient enrolled

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Horan, MD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Healthcare of Atlanta

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Rifaximin for Preventing Acute Graft Versus Host Disease (AGVHD)

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