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Clinical Trials in Canada / NCT03057054
Active, not recruiting Phase 3

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

NCT03057054 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2018-04-30
Last updated
2025-10-06

Condition(s) studied

Acute Graft Versus Host DiseaseHematopoietic and Lymphatic System NeoplasmLeukemiaLymphoma

Investigational drug(s) / intervention(s)

Allogeneic Hematopoietic Stem Cell TransplantationLactobacillus plantarum strain 299Lactobacillus plantarum strain 299vPlacebo Administration

Allogeneic Hematopoietic Stem Cell Transplantation: Undergo alloHCT

Lactobacillus plantarum strain 299: Given PO or via NJ, NG or G tube

Lactobacillus plantarum strain 299v: Given PO or via NJ, NG or G tube

Placebo Administration: Given PO or via NJ, NG or G tube

Study summary

This randomized phase III 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
25 Years
Healthy volunteers
No
Inclusion Criteria: * All clinical and laboratory studies, if applicable, must be obtained within 21 days prior to start of protocol therapy (repeat if necessary); protocol therapy must begin within 6 months of study enrollment * Patient must have a diagnosis that is managed with an alternative donor allogeneic hematopoietic cell transplant * Patients must have a Lansky (for patients =\< 16 years of age) or Karnofsky (for patients \> 16 years of age) performance status score of \>= 70; patients who are unable to walk because of a chronic underlying condition (such as paralysis), but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing performance score * Hematopoietic cell transplant (HCT) * Patient must be receiving cells from alternative donor defined as one of the following: * Unrelated donor with a complete human leukocyte antigen (HLA) match or a 1 or 2 HLA mismatch, considering only HLA-A, HLA-B, HLA-C, and HLA-DRB1 * Related donor with a 1 or more HLA mismatch (including haplo-identical) * Note: History of HCT or other cellular therapy (e.g. chimeric antigen receptor \[CAR\]-T cells, donor lymphocyte infusions) is permitted Exclusion Criteria: * Patient plans on receiving stem cells from a matched (8/8) related donor * Patient has used a probiotic dietary supplement within the previous 30 days of enrollment; (consumption of yogurt products is allowed) * 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), history of gastrointestinal GVHD, or history of bowel resection * Patient has a medical, psychiatric or social issue that would compromise patient safety or compliance with protocol therapy, or 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 * Patient has diarrhea at the time of enrollment which is Clostridium difficile toxin positive * Patient is receiving antibiotic therapy for an active bacterial infection * Patient is allergic to all third or fourth generation cephalosporins, carbapenems, and all aminoglycosides, which are used to empirically treat LBP bacteremia

Primary outcome measure(s)

Trial sites (43)

FacilityCityRegionStatus
Children's Hospital of Alabama Birmingham Alabama
City of Hope Comprehensive Cancer Center Duarte California
Children's Hospital Los Angeles Los Angeles California
UCSF Benioff Children's Hospital Oakland Oakland California
Rady Children's Hospital - San Diego San Diego California
UCSF Medical Center-Mission Bay San Francisco California
Children's Hospital Colorado Aurora Colorado
Yale University New Haven Connecticut
Alfred I duPont Hospital for Children Wilmington Delaware
Children's National Medical Center Washington D.C. District of Columbia
University of Florida Health Science Center - Gainesville Gainesville Florida
Nemours Children's Clinic-Jacksonville Jacksonville Florida
Nemours Children's Hospital Orlando Florida
Johns Hopkins All Children's Hospital St. Petersburg Florida
Kapiolani Medical Center for Women and Children Honolulu Hawaii
Riley Hospital for Children Indianapolis Indiana
Children's Hospital New Orleans New Orleans Louisiana
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
Dana-Farber Cancer Institute Boston Massachusetts
C S Mott Children's Hospital Ann Arbor Michigan
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids Michigan
University of Mississippi Medical Center Jackson Mississippi
Children's Mercy Hospitals and Clinics Kansas City Missouri
Hackensack University Medical Center Hackensack New Jersey
Roswell Park Cancer Institute Buffalo New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
University of Rochester Rochester New York
New York Medical College Valhalla New York
UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
Cleveland Clinic Foundation Cleveland Ohio
Nationwide Children's Hospital Columbus Ohio
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
Oregon Health and Science University Portland Oregon
Children's Hospital of Philadelphia Philadelphia Pennsylvania
The Children's Hospital at TriStar Centennial Nashville Tennessee
Vanderbilt University/Ingram Cancer Center Nashville Tennessee
Medical City Dallas Hospital Dallas Texas
Children's Hospital of San Antonio San Antonio Texas
Methodist Children's Hospital of South Texas San Antonio Texas
University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin

+ 3 more sites — see the full list on the official registry below.

More Children's Oncology Group trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03057054 on ClinicalTrials.gov ↗ ← All trials in Canada