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NCT03057054 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Lymphoma and Leukemia, sponsored by Children's Oncology Group.

Active
Registry status
Phase 3
Development phase
173
Enrollment target
20
Study locations

NCT03057054 is a Phase 3 study of Lymphoma and Leukemia that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 173 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT03057054, a Phase 3 study of Lymphoma and Leukemia, is active but no longer recruiting, sponsored by Children's Oncology Group.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
173 participants
Enrollment target
20
Study locations

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.

Interventions

  • PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
  • OTHER Placebo Administration
  • BIOLOGICAL Lactobacillus plantarum strain 299
  • BIOLOGICAL Lactobacillus plantarum strain 299v

Study Locations (20)

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • Children's Hospital Los Angeles - Los Angeles
  • UCSF Benioff Children's Hospital Oakland - Oakland
  • Rady Children's Hospital - San Diego - San Diego
  • UCSF Medical Center-Mission Bay - San Francisco

Florida

  • University of Florida Health Science Center - Gainesville - Gainesville
  • Nemours Children's Clinic-Jacksonville - Jacksonville
  • Nemours Children's Hospital - Orlando
  • Johns Hopkins All Children's Hospital - St. Petersburg

Alabama

  • Children's Hospital of Alabama - Birmingham

Colorado

  • Children's Hospital Colorado - Aurora

Connecticut

  • Yale University - New Haven

Delaware

  • Alfred I duPont Hospital for Children - Wilmington

District of Columbia

  • Children's National Medical Center - Washington D.C.

Hawaii

  • Kapiolani Medical Center for Women and Children - Honolulu

Trial Details

FieldValue
Enrollment Target 173 participants
Start Date 2018-04-30
Est. Completion 2026-06-30
Phase Phase 3

Sponsor

Children's Oncology Group

342 total trials

What the Registry Record Tells You About NCT03057054

The ClinicalTrials.gov registry entry for NCT03057054 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 173 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (64% lower). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Allogeneic Hematopoietic Stem Cell Transplantation is the first listed.

NCT03057054 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Florida, Alabama.

Frequently Asked Questions

What is clinical trial NCT03057054 about?

NCT03057054 is a clinical study titled "Lactobacillus Plantarum in Preventing Acute Graft Versus Host Disease in Children Undergoing Donor Stem Cell Transplant". 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, adolesce...

What is the current status of trial NCT03057054?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 173 participants. The study started on 2018-04-30. Estimated completion is 2026-06-30.

What conditions does trial NCT03057054 study?

This clinical trial studies the following conditions: Lymphoma, Leukemia, Hematopoietic and Lymphatic System Neoplasm, Acute-graft-versus-host Disease.

What interventions are being tested in trial NCT03057054?

The interventions under investigation include: Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Placebo Administration (OTHER), Lactobacillus plantarum strain 299 (BIOLOGICAL), Lactobacillus plantarum strain 299v (BIOLOGICAL).

Who is sponsoring clinical trial NCT03057054?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03057054 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.