Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Lymphoma and Leukemia, sponsored by Children's Oncology Group.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The proportion of eligible patients having stage 1-4 GI aGvHD occur from Day 0 through Day 120 will be compared between the two arms.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2018-04-30 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
What the registry record for NCT03057054 still lists
NCT03057054 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (64% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03057054's enrollment target sits among peer trials
173 55th of 299 higher than 245 of 299 other Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
RECRUITING · Phase 3
-
Geriatric Evaluation and Management With Survivorship Health Education for Older Survivors of Cancer, GEM-S Trial
RECRUITING · Phase 3
-
Post-Op Pain Control for Prophylactic Intramedullary Nailing.
RECRUITING · Phase 3
-
Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression
ACTIVE NOT RECRUITING · Phase 3
-
Epoetin Alfa in Treating Anemia in Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma and Anemia Caused By Chemotherapy
COMPLETED · Phase 3
-
Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Older Patients With Non-Hodgkin's Lymphoma
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05568719 · 173 participants · Phase 3
Safety and Effectiveness of Giroctocogene Fitelparvovec or Fidanacogene Elaparvovec in Patients With Hemophilia A or B Respectively
- NCT07070115 · 173 participants · NA
Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®
- NCT07150832 · 173 participants · NA
Efficacy of the I-CARE Digital Health Intervention
- NCT01000259 · 174 participants
Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI