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

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv38
  2. Completion date: Jun 30, 2024 to Jun 30, 2026 Study sites revised (43)v37 Show 1 more changeShow less
    • Study sites revised (43)

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Completed to Active, Not Recruiting Completion date: Jun 30, 2023 to Jun 30, 2024v36 Show 1 more changeShow less
    • Completion date: Jun 30, 2023 to Jun 30, 2024
  4. Re-verified, no change to tracked fieldsv35
  5. Results first posted: Jul 17, 2023 Trial status: Active, Not Recruiting to Completedv34 Show 1 more changeShow less
    • Trial status: Active, Not Recruiting to Completed
Show 32 earlier versionsHide 32 earlier versions
  1. Primary endpoint revisedv33 See this version in full on ClinicalTrials.gov ↗
  2. Enrollment target: 167 to 173 Primary endpoint revisedv32 Show 1 more changeShow less
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv31
  4. Enrollment target: estimated 500 to confirmed 167 Primary completion date changed from estimate of Jun 30, 2023 to Jun 30, 2022v30 Show 1 more changeShow less
    • Primary completion date changed from estimate of Jun 30, 2023 to Jun 30, 2022
  5. Primary and study completion dates: Sep 30, 2022 to Jun 30, 2023v29
  6. Primary and study completion dates: Jun 30, 2022 to Sep 30, 2022v28
  7. Primary and study completion dates: Oct 30, 2023 to Jun 30, 2022v27
  8. Study sites revised (43)v26 See this version in full on ClinicalTrials.gov ↗
  9. Study sites revised (43)v25 See this version in full on ClinicalTrials.gov ↗
  10. Trial status: Recruiting to Active, Not Recruiting Site details revised at 43 of 43 sitesv24 Show 1 more changeShow less
    • Site details revised at 43 of 43 sites
  11. Site details revised at 4 of 43 sitesv23
  12. Site contacts updated at 1 of 43 sitesv22
  13. Primary and study completion dates: Aug 1, 2023 to Oct 30, 2023 Eligibility criteria expanded, about 33 words · Study description expanded, about 3 wordsv21 Show 2 more changesShow less
    • Eligibility criteria expanded, about 33 words
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites revised (43)v20 See this version in full on ClinicalTrials.gov ↗
  15. Study sites: 41 to 43v19
  16. Site contacts updated at 3 of 41 sitesv18
  17. Study sites: 39 to 41v17
  18. Study sites: 38 to 39v16
  19. Primary and study completion dates: Oct 30, 2023 to Aug 1, 2023 Interventions: Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Lactobacillus plantarum strain 299 (Biological), Lactobacillus plantarum… to Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Lactobacillus plantarum strain 299 (Biological), Lactobacillus plantarum… · Study sites revised (38)v15 Show 2 more changesShow less
    • Interventions: Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Lactobacillus plantarum strain 299 (Biological), Lactobacillus plantarum… to Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Lactobacillus plantarum strain 299 (Biological), Lactobacillus plantarum…
    • Study sites revised (38)

    See this version in full on ClinicalTrials.gov ↗

  20. Study sites: 37 to 38v14
  21. Primary endpoint revised Eligibility criteria revised · Study description revised · Site details revised at 1 of 37 sitesv13 Show 3 more changesShow less
    • Eligibility criteria revised
    • Study description revised
    • Site details revised at 1 of 37 sites

    See this version in full on ClinicalTrials.gov ↗

  22. Primary endpoint revised Study sites: 33 to 37 · Primary and study completion dates: Aug 1, 2023 to Oct 30, 2023 · Interventions: Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Laboratory Biomarker Analysis (Other), Lactobacillus plantarum strain 299… to Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Lactobacillus plantarum strain 299 (Biological), Lactobacillus plantarum… · 2 morev12 Show 5 more changesShow less
    • Study sites: 33 to 37
    • Primary and study completion dates: Aug 1, 2023 to Oct 30, 2023
    • Interventions: Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Laboratory Biomarker Analysis (Other), Lactobacillus plantarum strain 299… to Allogeneic Hematopoietic Stem Cell Transplantation (Procedure), Lactobacillus plantarum strain 299 (Biological), Lactobacillus plantarum…
    • Eligibility criteria expanded, about 16 words
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  23. Study sites: 31 to 33v11
  24. Study sites: 15 to 31v10
  25. Study sites: 1 to 15v9
  26. Primary endpoint revised Study sites: 2 to 1 · Completion date: Dec 2023 to Aug 1, 2023 · Eligibility criteria expanded, about 10 words · 1 morev8 Show 4 more changesShow less
    • Study sites: 2 to 1
    • Completion date: Dec 2023 to Aug 1, 2023
    • Eligibility criteria expanded, about 10 words
    • Study description expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  27. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 2 · Primary completion date: Mar 2023 to Aug 1, 2023 · Completion date: Mar 2023 to Dec 2023 · 1 morev7 Show 4 more changesShow less
    • Study sites: 1 to 2
    • Primary completion date: Mar 2023 to Aug 1, 2023
    • Completion date: Mar 2023 to Dec 2023
    • Start date changed from estimate of Mar 2018 to Apr 30, 2018
  28. Start date: Dec 2017 to Mar 2018 Primary and study completion dates: Dec 2022 to Mar 2023v6 Show 1 more changeShow less
    • Primary and study completion dates: Dec 2022 to Mar 2023
  29. Start date: Sep 2017 to Dec 2017v5
  30. Start date: May 2017 to Sep 2017v4
  31. Phase: Not applicable to Phase 3 Completion date: Dec 2022v3 Show 1 more changeShow less
    • Completion date: Dec 2022
  32. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03057054
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions Acute Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm, Leukemia, Lymphoma
Enrollment 173 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov