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Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia

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

Record History

  1. Completion date: Sep 22, 2025 to Jun 30, 2029v26
  2. Completion date: Sep 22, 2024 to Sep 22, 2025 Study sites revised (174)v25 Show 1 more changeShow less
    • Study sites revised (174)

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  3. Completion date: Oct 31, 2025 to Sep 22, 2024 Start date: Jun 29, 2015 to Jul 21, 2015 · Study sites revised (174)v24 Show 2 more changesShow less
    • Start date: Jun 29, 2015 to Jul 21, 2015
    • Study sites revised (174)

    See this version in full on ClinicalTrials.gov ↗

  4. 2 versions Re-verified since May 20, 2023, no change to tracked fieldsv22-v23
  5. Study sites revised (174)v21 See this version in full on ClinicalTrials.gov ↗
Show 19 earlier versionsHide 19 earlier versions
  1. Re-verified, no change to tracked fieldsv20
  2. Results first posted: Dec 16, 2021 Completion date: Oct 31, 2025 · Primary endpoints revised (2) · Study sites revised (174)v19 Show 3 more changesShow less
    • Completion date: Oct 31, 2025
    • Primary endpoints revised (2)
    • Study sites revised (174)

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Completed to Active, Not Recruiting Primary completion date: Sep 30, 2020 to Oct 31, 2020 · Completion date: Sep 30, 2020 to not statedv18 Show 2 more changesShow less
    • Primary completion date: Sep 30, 2020 to Oct 31, 2020
    • Completion date: Sep 30, 2020 to not stated
  4. Trial status: Active, Not Recruiting to Completed Primary completion date changed from estimate of Jun 30, 2021 to Sep 30, 2020 · Completion date: Sep 30, 2020 · Eligibility criteria revised · 1 morev17 Show 4 more changesShow less
    • Primary completion date changed from estimate of Jun 30, 2021 to Sep 30, 2020
    • Completion date: Sep 30, 2020
    • Eligibility criteria revised
    • Study sites revised (174)

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites revised (174)v16 See this version in full on ClinicalTrials.gov ↗
  6. Study sites revised (174)v15 See this version in full on ClinicalTrials.gov ↗
  7. Study description revisedv14 See this version in full on ClinicalTrials.gov ↗
  8. Trial status: Recruiting to Active, Not Recruiting Study sites: 175 to 174v13 Show 1 more changeShow less
    • Study sites: 175 to 174
  9. Study sites: 174 to 175v12
  10. Study sites: 172 to 174v11
  11. Primary completion date: Apr 30, 2023 to Jun 30, 2021 Study sites revised (172)v10 Show 1 more changeShow less
    • Study sites revised (172)

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  12. Study sites: 171 to 172v9
  13. Primary endpoints revised (2) Study sites: 1 to 171 · Primary completion date: Apr 2023 to Apr 30, 2023 · Completion date: Apr 2023 to not stated · 4 morev8 Show 7 more changesShow less
    • Study sites: 1 to 171
    • Primary completion date: Apr 2023 to Apr 30, 2023
    • Completion date: Apr 2023 to not stated
    • Start date: Jun 2015 to Jun 29, 2015
    • Interventions: Arsenic Trioxide (Drug), Cytarabine (Drug), Dexamethasone (Drug), Idarubicin (Drug), Laboratory Biomarker Analysis (Other), Mitoxantrone… to Arsenic Trioxide (Drug), Cytarabine (Drug), Dexamethasone (Drug), Idarubicin (Drug), Laboratory Biomarker Analysis (Other), Mitoxantrone…
    • Eligibility criteria revised
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  14. Completion date: Apr 2023v7
  15. 3 versions Re-verified since Jun 30, 2015, no change to tracked fieldsv4-v6
  16. Trial status: Not Yet Recruiting to Recruiting Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  17. Start date: Apr 2015 to Jun 2015 Interventions: arsenic trioxide (Drug), cytarabine (Drug), dexamethasone (Drug), idarubicin hydrochloride (Drug), laboratory biomarker analysis (Other)… to Arsenic Trioxide (Drug), Cytarabine (Drug), Dexamethasone (Drug), Idarubicin (Drug), Laboratory Biomarker Analysis (Other), Mitoxantrone… · Eligibility criteria shortened, about 27 words · Study site revised · 1 morev2 Show 4 more changesShow less
    • Interventions: arsenic trioxide (Drug), cytarabine (Drug), dexamethasone (Drug), idarubicin hydrochloride (Drug), laboratory biomarker analysis (Other)… to Arsenic Trioxide (Drug), Cytarabine (Drug), Dexamethasone (Drug), Idarubicin (Drug), Laboratory Biomarker Analysis (Other), Mitoxantrone…
    • Eligibility criteria shortened, about 27 words
    • Study site revised
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  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 phase III trial studies tretinoin and arsenic trioxide in treating patients with newly diagnosed acute promyelocytic leukemia. Standard treatment for acute promyelocytic leukemia involves high doses of a common class of chemotherapy drugs called anthracyclines, which are known to cause long-term side effects, especially to the heart. Tretinoin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Arsenic trioxide may stop the growth of cancer cells by either killing the cells, by stopping them from dividing, or by stopping them from spreading. Completely removing or reducing the amount of anthracycline chemotherapy and giving tretinoin together with arsenic trioxide may be an effective treatment for acute promyelocytic leukemia and may reduce some of the long-term side effects.
Trial Details
NCT Number NCT02339740
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions Acute Promyelocytic Leukemia With t(15;17)(q24.1;q21.2); PML-RARA
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov