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Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome

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

Record History

  1. Completion pushed from Jun 30, 2026 to Jun 30, 2027 Study sites revised (191)v48 Show 1 more changeShow less
    • Study sites revised (191)

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  2. Completion date: Jul 4, 2025 to Jun 30, 2026v47
  3. Re-verified, no change to tracked fieldsv46
  4. Results first posted: Jun 13, 2025 Primary endpoint revisedv45 Show 1 more changeShow less
    • Primary endpoint revised

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  5. Study sites revised (191)v44 See this version in full on ClinicalTrials.gov ↗
Show 42 earlier versionsHide 42 earlier versions
  1. Study sites revised (191)v43 See this version in full on ClinicalTrials.gov ↗
  2. Primary endpoint revisedv42 See this version in full on ClinicalTrials.gov ↗
  3. Enrollment target: estimated 312 to confirmed 280 Completion date: Jun 30, 2024 to Jul 4, 2025 · Study sites revised (191)v41 Show 2 more changesShow less
    • Completion date: Jun 30, 2024 to Jul 4, 2025
    • Study sites revised (191)

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Nov 23, 2015 to Dec 23, 2015v40
  5. Study sites revised (191)v39 See this version in full on ClinicalTrials.gov ↗
  6. 3 versions Re-verified since Mar 8, 2023, no change to tracked fieldsv36-v38
  7. Study sites revised (191)v35 See this version in full on ClinicalTrials.gov ↗
  8. Study sites revised (191)v34 See this version in full on ClinicalTrials.gov ↗
  9. Re-verified, no change to tracked fieldsv33
  10. Primary and study completion dates: Sep 30, 2025 to Jun 30, 2024v32
  11. Trial status: Recruiting to Active, Not Recruiting Study sites revised (191)v31 Show 1 more changeShow less
    • Study sites revised (191)

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  12. Site details revised at 2 of 191 sites Study description expanded, about 1 wordv30 Show 1 more changeShow less
    • Study description expanded, about 1 word

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  13. Primary completion date: Jun 30, 2023 to Sep 30, 2025 Completion date: Sep 30, 2025 · Site details revised at 6 of 191 sitesv29 Show 2 more changesShow less
    • Completion date: Sep 30, 2025
    • Site details revised at 6 of 191 sites
  14. Study sites: 190 to 191v28
  15. Site details revised at 9 of 190 sitesv27
  16. Site details revised at 3 of 190 sitesv26
  17. Study sites: 189 to 190v25
  18. Site details revised at 10 of 189 sitesv24
  19. Study sites: 188 to 189v23
  20. Study sites: 187 to 188v22
  21. Study sites revised (187)v21 See this version in full on ClinicalTrials.gov ↗
  22. Enrollment target: 256 to 312 Study sites: 186 to 187 · Interventions: Asparaginase (Drug), Asparaginase Erwinia chrysanthemi (Drug), Cytarabine (Drug), Daunorubicin (Drug), Daunorubicin Hydrochloride (Drug)… to Asparaginase (Drug), Asparaginase Erwinia chrysanthemi (Drug), Cytarabine (Drug), Daunorubicin Hydrochloride (Drug), Etoposide (Drug)… · Eligibility criteria expanded, about 12 wordsv20 Show 3 more changesShow less
    • Study sites: 186 to 187
    • Interventions: Asparaginase (Drug), Asparaginase Erwinia chrysanthemi (Drug), Cytarabine (Drug), Daunorubicin (Drug), Daunorubicin Hydrochloride (Drug)… to Asparaginase (Drug), Asparaginase Erwinia chrysanthemi (Drug), Cytarabine (Drug), Daunorubicin Hydrochloride (Drug), Etoposide (Drug)…
    • Eligibility criteria expanded, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  23. Primary completion date: Mar 31, 2023 to Jun 30, 2023 Eligibility criteria revised · Study sites revised (186)v19 Show 2 more changesShow less
    • Eligibility criteria revised
    • Study sites revised (186)

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  24. Study sites: 185 to 186v18
  25. Study sites: 184 to 185v17
  26. Study sites: 182 to 184v16
  27. Primary completion date: Mar 31, 2022 to Mar 31, 2023v15
  28. Study sites: 178 to 182v14
  29. Eligibility criteria revised Study sites revised (178)v13 Show 1 more changeShow less
    • Study sites revised (178)

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  30. Interventions: Asparaginase (Drug), Asparaginase Erwinia chrysanthemi (Drug), Cytarabine (Drug), Daunorubicin Hydrochloride (Drug), Etoposide (Drug)… to Asparaginase (Drug), Asparaginase Erwinia chrysanthemi (Drug), Cytarabine (Drug), Daunorubicin (Drug), Daunorubicin Hydrochloride (Drug)… Study sites revised (178)v12 Show 1 more changeShow less
    • Study sites revised (178)

    See this version in full on ClinicalTrials.gov ↗

  31. Primary endpoint revised Study sites: 177 to 178v11 Show 1 more changeShow less
    • Study sites: 177 to 178

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  32. Study sites: 173 to 177v10
  33. Study description shortened, about 162 words Study sites revised (173)v9 Show 1 more changeShow less
    • Study sites revised (173)

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  34. Primary completion date: Dec 1, 2019 to Mar 31, 2022 Site details revised at 1 of 173 sitesv8 Show 1 more changeShow less
    • Site details revised at 1 of 173 sites
  35. Primary endpoint revised Study sites: 36 to 173 · Primary completion date: Dec 2019 to Dec 1, 2019 · Start date: Nov 2015 to Nov 23, 2015 · 2 morev7 Show 5 more changesShow less
    • Study sites: 36 to 173
    • Primary completion date: Dec 2019 to Dec 1, 2019
    • Start date: Nov 2015 to Nov 23, 2015
    • Eligibility criteria expanded, about 54 words
    • Study description expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  36. 2 versions Re-verified since Aug 18, 2016, no change to tracked fieldsv5-v6
  37. Study sites: 15 to 36 Secondary endpoints shortened, about 54 words · Study description revisedv4 Show 2 more changesShow less
    • Secondary endpoints shortened, about 54 words
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  38. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 15 · Start date: Mar 2016 to Nov 2015v3 Show 2 more changesShow less
    • Study sites: 1 to 15
    • Start date: Mar 2016 to Nov 2015
  39. Start date: Aug 2015 to Mar 2016 Eligibility criteria shortened, about 16 words · Study description shortened, about 39 wordsv2 Show 2 more changesShow less
    • Eligibility criteria shortened, about 16 words
    • Study description shortened, about 39 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 response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.
Trial Details
NCT Number NCT02521493
Lead Sponsor Children's Oncology Group
Collaborators: National Cancer Institute (NCI)
Conditions Acute Myeloid Leukemia, Down Syndrome, Myelodysplastic Syndrome, Myeloid Leukemia Associated With Down Syndrome, Myeloproliferative Neoplasm
Enrollment 280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov