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ACTIVE NOT RECRUITING

NCT03057054

PHASE3

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

Sponsor: Children's Oncology Group

View on ClinicalTrials.gov

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.

Official title: The Effectiveness of Lactobacillus Plantarum (LBP, IND# 17339) in Preventing Acute Graft-Versus-Host Disease (GvHD) in Children Undergoing Alternative Hematopoietic Progenitor Cell Transplantation (HCT)

Key Details

Gender

All

Age Range

2 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

173

Start Date

2018-04-30

Completion Date

2026-06-30

Last Updated

2025-10-06

Healthy Volunteers

Conditions

Acute Graft Versus Host Disease Hematopoietic and Lymphatic System Neoplasm Leukemia Lymphoma

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo alloHCT

BIOLOGICAL

Lactobacillus plantarum strain 299

Given PO or via NJ, NG or G tube

BIOLOGICAL

Lactobacillus plantarum strain 299v

Given PO or via NJ, NG or G tube

OTHER

Placebo Administration

Given PO or via NJ, NG or G tube

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

Locations (43)

Children's Hospital of Alabama

Birmingham, Alabama, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

Rady Children's Hospital - San Diego

San Diego, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Yale University

New Haven, Connecticut, United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States

Nemours Children's Hospital

Orlando, Florida, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Children's Hospital New Orleans

New Orleans, Louisiana, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

New York Medical College

Valhalla, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Oregon Health and Science University

Portland, Oregon, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

The Children's Hospital at TriStar Centennial

Nashville, Tennessee, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Medical City Dallas Hospital

Dallas, Texas, United States

Children's Hospital of San Antonio

San Antonio, Texas, United States

Methodist Children's Hospital of South Texas

San Antonio, Texas, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Alberta Children's Hospital

Calgary, Alberta, Canada

Hospital for Sick Children

Toronto, Ontario, Canada

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (43)