Lactobacillus Plantarum in Preventing Acute Graft Versus Host Disease in Children Undergoing Donor Stem Cell Transplant

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 500
• Participant gender: All

Summary

This randomized clinical trial studies how well Lactobacillus plantarum works in preventing acute graft versus host disease in children undergoing donor stem cell transplant. Lactobacillus plantarum may help prevent the development of gastrointestinal graft versus host disease in children, adolescents, and young adults undergoing donor stem cell transplant.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Last Updated: 2017-07-18

Criteria

Inclusion Criteria:

• Patient must have a diagnosis that is managed with an allogeneic hematopoietic cell transplant

• Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0 or 1 (>= 70% for Karnofsky/Lansky); use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age

• Hematopoietic cell transplant (HCT)

• No previous history of HCT or other cellular therapy (e.g., chimeric antigen receptor [CAR]-T cells, donor lymphocyte infusions)

• Patient must be undergoing a first allogeneic HCT and receiving cells from an first alternative donor defined as all donors except for 8/8 human leukocyte antigen (HLA)-matched, related family members

• Patient must not have used a probiotic dietary supplement within the previous 30 days of starting the transplant conditioning regimen (consumption of yogurt products is allowed)

• If patient has diarrhea at the time of enrollment, the patient must be Clostridium difficile toxin negative

• Patients who develop diarrhea after enrollment should be evaluated for Clostridium difficile (C. diff) to ensure they are negative prior to the start of the conditioning regimen and day 1 of study dosing; if they are positive, they will be deemed ineligible

• Patient is not receiving antibiotics therapy for an active infection

Exclusion Criteria:

• Patient has a history of severe GI tract insult including but not limited to previous bowel perforation, grade 4 neutropenic colitis or typhlitis, inflammatory bowel syndrome, short small bowel syndrome (Crohn's disease, ulcerative colitis) or history of bowel resection

• Patient has significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with protocol therapy, interfere with consent, study participation, follow up, or interpretation of study results

• Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test prior to enrollment