Gut Decontamination In Pediatric Allogeneic Hematopoietic

Status: Recruiting
Phase: Phase 2
DFCI Protocol ID: 15-394

This research study is for participants who are undergoing allogeneic hematopoietic stem cell transplantation (HSCT) and are at risk for developing acute graft-versus-host disease (GVHD). GVHD is a complication of HSCT in which immune cells from the donor cause inflammation and injury to tissues and organs of the HSCT recipient. Vancomycin-polymyxin B (commonly called "vancopoly") is an oral antibiotic that is given to people undergoing allogeneic HSCT as a preventive measure for acute GVHD. This research study is studying the effects of vancopoly on the microorganisms living in the intestine during and after stem cell transplantation.

Conducting Institutions:

Dana-Farber Cancer Institute, Children's Hospital Boston

Overall PI:

Jennifer Whangbo, MD, PhD, Dana Farber Cancer Institute

Site-responsible Investigators:


Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP,

Eligibility Criteria

Inclusion Criteria:

  -  Eligibility Criteria for Patients Undergoing Allogeneic HSCT

       -  Recipient of 10/10 (HLA-A, -B, -C, -DRB1, -DQB1) matched bone marrow allogeneic
  hematopoietic stem cell transplantation (HSCT) OR 6/6 (HLA-A, -B, -DR) matched
  cord blood allogeneic HSCT.

       -  Participants may have underlying malignant or non-malignant hematologic disease,
  except for primary immunodeficiency, as the indication for their allogeneic

       -  Participants must receive a myeloablative conditioning regimen. Anti-thymocyte
  globulin (ATG) in the conditioning regimen is permitted.

       -  Graft-versus-host disease (GVHD) prophylaxis with a calcineurin inhibitor and
  short-course methotrexate with or without steroids.

       -  Age ≥ 4 years old and toilet-trained. Participants must be able to deposit stool
  samples directly into stool collection containers. Stool specimens from diapers
  are difficult to obtain and are prone to more sampling error, particularly for
  loose or liquid stools which are common in the peri-transplant period.

       -  Lansky/Karnofsky performance status ≥60% (see Appendix A)

       -  Ability to understand and/or the willingness of their parent or legally
  authorized representative to sign a written informed consent document

  -  Eligibility Criteria for Healthy Bone Marrow Donors

       -  Healthy individuals, ages ≥ 4 years and toilet-trained, who have been identified
  by BCH or DFCI providers as fully-matched, sibling bone marrow donors for
  transplantation will also be eligible to participate in this study.

Exclusion Criteria:

  -  Patients undergoing allogeneic HSCT for correction of a primary immunodeficiency
     disorder (e.g. SCID).

  -  Recipients of mismatched allogeneic HSCT.

  -  Patients receiving a reduced-intensity (non-myeloablative) conditioning regimen.

  -  Patients with age ≤ 10 years undergoing HSCT with a matched sibling donor. These
     patients are at very low risk of acute GVHD and do not receive gut decontamination
     per our institutional standard practice.

  -  Participants receiving GVHD prophylaxis with drugs other than calcineurin inhibitors,
     methotrexate or steroids.

  -  History of allergic reactions attributed to oral vancomycin or oral polymyxin B.

  -  Participants undergoing active therapy for immune-mediated or infectious colitis upon
     admission for allogeneic HSCT.

  -  Participants receiving antibiotic therapy for treatment of a bacterial infection or
     bacterial prophylaxis upon admission for allogeneic HSCT. Use of any agent (e.g.
     sulfamethoxazole/trimethoprim) for prophylaxis of Pneumocystis jirovecii pneumonia is
     permitted. Concurrent use of anti-fungal and anti-viral therapies is also permitted.

  -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
     infection or psychiatric illness/social situations that would limit compliance with
     study requirements.

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