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Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 71 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Study sites: 162 to 164v71
  2. Study sites: 161 to 162v70
  3. Study sites revised (161)v69 See this version in full on ClinicalTrials.gov ↗
  4. Site details revised at 2 of 161 sitesv68
  5. Study description shortened, about 2 wordsv67 See this version in full on ClinicalTrials.gov ↗
Show 45 earlier versionsHide 45 earlier versions
  1. Primary and study completion dates: Sep 30, 2026 to Sep 30, 2030 Site details revised at 2 of 161 sitesv66 Show 1 more changeShow less
    • Site details revised at 2 of 161 sites
  2. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 724 to 750 · Interventions: Autologous Hematopoietic Stem Cell Transplantation (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration and Biopsy… to Autologous Hematopoietic Stem Cell Transplantation (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration and Biopsy… · Eligibility criteria expanded, about 923 words · 2 morev65 Show 5 more changesShow less
    • Enrollment target: 724 to 750
    • Interventions: Autologous Hematopoietic Stem Cell Transplantation (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration and Biopsy… to Autologous Hematopoietic Stem Cell Transplantation (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration and Biopsy…
    • Eligibility criteria expanded, about 923 words
    • Study description expanded, about 101 words
    • Site details revised at 161 of 161 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv64
  4. Study sites revised (161)v63 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (161)v62 See this version in full on ClinicalTrials.gov ↗
  6. 2 versions Re-verified since Mar 18, 2025, no change to tracked fieldsv60-v61
  7. Study sites revised (161)v59 See this version in full on ClinicalTrials.gov ↗
  8. Re-verified, no change to tracked fieldsv58
  9. Study sites revised (161)v57 See this version in full on ClinicalTrials.gov ↗
  10. Study description expanded, about 6 wordsv56 See this version in full on ClinicalTrials.gov ↗
  11. Interventions: Autologous Hematopoietic Stem Cell Transplantation (Procedure), Busulfan (Drug), Carboplatin (Drug), Cisplatin (Drug), Cyclophosphamide… to Autologous Hematopoietic Stem Cell Transplantation (Procedure), Biospecimen Collection (Procedure), Bone Marrow Aspiration and Biopsy… Study description expanded, about 167 wordsv55 Show 1 more changeShow less
    • Study description expanded, about 167 words

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites revised (161)v54 See this version in full on ClinicalTrials.gov ↗
  13. 5 versions Re-verified since Oct 26, 2023, no change to tracked fieldsv49-v53
  14. Trial status: Recruiting to Active, Not Recruiting Start date: May 9, 2018 to May 14, 2018 · Site details revised at 161 of 161 sitesv48 Show 2 more changesShow less
    • Start date: May 9, 2018 to May 14, 2018
    • Site details revised at 161 of 161 sites
  15. Site details revised at 3 of 161 sitesv47
  16. Site details revised at 9 of 161 sitesv46
  17. Study sites: 160 to 161v45
  18. Re-verified, no change to tracked fieldsv44
  19. Enrollment target: 658 to 724 Study description revised · Site details revised at 4 of 160 sitesv43 Show 2 more changesShow less
    • Study description revised
    • Site details revised at 4 of 160 sites

    See this version in full on ClinicalTrials.gov ↗

  20. Site contacts updated at 2 of 160 sites Study description shortened, about 3 wordsv42 Show 1 more changeShow less
    • Study description shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  21. Study sites: 159 to 160 Study description expanded, about 15 wordsv41 Show 1 more changeShow less
    • Study description expanded, about 15 words

    See this version in full on ClinicalTrials.gov ↗

  22. Site details revised at 2 of 159 sitesv40
  23. Study sites: 158 to 159v39
  24. Site details revised at 14 of 158 sitesv38
  25. Site details revised at 10 of 158 sitesv37
  26. Enrollment target: 813 to 658 Study sites: 154 to 158 · Interventions: Autologous Hematopoietic Stem Cell Transplantation (Procedure), Busulfan (Drug), Carboplatin (Drug), Cisplatin (Drug), Crizotinib (Drug)… to Autologous Hematopoietic Stem Cell Transplantation (Procedure), Busulfan (Drug), Carboplatin (Drug), Cisplatin (Drug), Cyclophosphamide… · Eligibility criteria expanded, about 17 words · 2 morev36 Show 5 more changesShow less
    • Study sites: 154 to 158
    • Interventions: Autologous Hematopoietic Stem Cell Transplantation (Procedure), Busulfan (Drug), Carboplatin (Drug), Cisplatin (Drug), Crizotinib (Drug)… to Autologous Hematopoietic Stem Cell Transplantation (Procedure), Busulfan (Drug), Carboplatin (Drug), Cisplatin (Drug), Cyclophosphamide…
    • Eligibility criteria expanded, about 17 words
    • Study description expanded, about 95 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  27. Study sites: 152 to 154v35
  28. Site details revised at 6 of 152 sitesv34
  29. Study sites: 150 to 152v33
  30. Study sites: 146 to 150v32
  31. Site details revised at 3 of 146 sitesv31
  32. Site details revised at 1 of 146 sitesv30
  33. Trial status: Active, Not Recruiting to Recruiting Study description expanded, about 8 words · Site details revised at 146 of 146 sitesv29 Show 2 more changesShow less
    • Study description expanded, about 8 words
    • Site details revised at 146 of 146 sites

    See this version in full on ClinicalTrials.gov ↗

  34. Study sites: 144 to 146v28
  35. Trial status: Recruiting to Active, Not Recruiting Site details revised at 144 of 144 sitesv27 Show 1 more changeShow less
    • Site details revised at 144 of 144 sites
  36. Site details revised at 5 of 144 sitesv26
  37. Study sites: 143 to 144 Interventions: Autologous Hematopoietic Stem Cell Transplantation (Procedure), Busulfan (Drug), Carboplatin (Drug), Cisplatin (Drug), Crizotinib (Drug)… to Autologous Hematopoietic Stem Cell Transplantation (Procedure), Busulfan (Drug), Carboplatin (Drug), Cisplatin (Drug), Crizotinib (Drug)… · Study description expanded, about 27 wordsv25 Show 2 more changesShow less
    • Interventions: Autologous Hematopoietic Stem Cell Transplantation (Procedure), Busulfan (Drug), Carboplatin (Drug), Cisplatin (Drug), Crizotinib (Drug)… to Autologous Hematopoietic Stem Cell Transplantation (Procedure), Busulfan (Drug), Carboplatin (Drug), Cisplatin (Drug), Crizotinib (Drug)…
    • Study description expanded, about 27 words

    See this version in full on ClinicalTrials.gov ↗

  38. Site details revised at 1 of 143 sitesv24
  39. Study sites: 140 to 143v23
  40. Study sites: 138 to 140v22
  • 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 phase III trial studies iobenguane I-131 or lorlatinib and standard therapy in treating younger patients with newly-diagnosed high-risk neuroblastoma or ganglioneuroblastoma. Radioactive drugs, such as iobenguane I-131, may carry radiation directly to tumor cells and not harm normal cells. Lorlatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving iobenguane I-131 or lorlatinib and standard therapy may work better compared to lorlatinib and standard therapy alone in treating younger patients with neuroblastoma or ganglioneuroblastoma.
Trial Details
NCT Number NCT03126916
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions Ganglioneuroblastoma, Ganglioneuroblastoma, Nodular, Neuroblastoma
Enrollment 750 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov