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Rifaximin in Preventing Infections in Participants with Blood Cancer Undergoing Hematopoietic Stem Cell Transplantation

Status
Active
Cancer Type
Hematopoietic Malignancies
Trial Phase
Phase I
Eligibility
2 - 21 Years, Male and Female
Study Type
Prevention
NCT ID
NCT03529825
Protocol IDs
CHOA4273-18 (primary)
NCI-2018-00596
IRB00101158
Study Sponsor
Children's Healthcare of Atlanta - Egleston

Summary

This pilot phase I trial studies how well rifaximin works in preventing infections and improving the balance of bacteria within the gut of participants with blood cancer who are undergoing blood and marrow transplantation. Rifaximin is an antibiotic used to treat intestinal infections by preventing bacteria from invading the intestinal wall. Giving rifaximin may help to prevent bacterial infections and improve transplant outcomes in participants undergoing hematopoietic stem cell transplantation.

Objectives

PRIMARY OBJECTIVE:
I. To describe the impact of rifaximin on gut microbiome diversity.

SECONDARY OBJECTIVE:
I. To estimate the rate of blood stream infections (BSI) in patients treated with rifaximin.

OUTLINE:
Participants receive rifaximin orally (PO) or enterally by gastric or naso-gastric/nasojejunal (NG/NJ) tube twice daily (BID) on day -7 or upon admittance to the hospital for hematopoietic stem cell transplantation (HSCT), whichever is later. Treatment continues for 28 days after HSCT or until discharge for a maximum of 36 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up on days 42 and 100, at 8 months, and at 1 year after HSCT.

Eligibility

  1. Allogeneic hematopoietic stem cell transplantation (HSCT) recipients
  2. Underlying hematologic malignancy, regardless of donor type or graft source
  3. Myeloablative conditioning regimen

Treatment Sites in Georgia

Aflac Cancer and Blood Disorders Center of Children’s at Egleston


1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.