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Daunorubicin Hydrochloride, Cytarabine and Oblimersen Sodium in Treating Patients With Previously Untreated Acute Myeloid Leukemia

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 74 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since May 29, 2024, no change to tracked fieldsv73-v74
  2. Study sites: 1 to 2v72
  3. Primary completion date: Dec 2009 to Jun 2007v71
  4. Primary completion date: Jun 2007 to Dec 2009v70 Show 11 more changesShow less
    • Primary endpoints: 1 to 3
    • Trial status: Active, Not Recruiting to Completed
    • Enrollment target: 507 to 500
    • Study sites: 172 to 1
    • Study completion date: Oct 2016 to not stated
    • Interventions: cytarabine (Drug), daunorubicin hydrochloride (Drug), oblimersen sodium (Biological) to cytarabine (Drug), daunorubicin hydrochloride (Drug), laboratory biomarker analysis (Other), oblimersen sodium (Biological)
    • Eligibility criteria shortened, about 28 words
    • Secondary endpoints shortened, about 6 words
    • Publications: 6 to 4
    • Study description expanded, about 4 words
    • Study title shortened, about 2 words
  5. Lead sponsor: Cancer and Leukemia Group B to National Cancer Institute (NCI)
    • Collaborators shortened, about 4 words
    v69
Show 44 earlier versionsHide 44 earlier versions
  1. Primary completion date: Nov 2007 to Jun 2007v68
  2. Primary completion date: Dec 2009 to Nov 2007v67 Show 6 more changesShow less
    • Trial status: Completed to Active, Not Recruiting
    • Enrollment target: estimated 500 to confirmed 507
    • Study completion date: Oct 2016
    • Secondary endpoints revised (3)
    • Site details revised at 1 of 172 sites
    • Study arms: 0 to 2
  3. Re-verified, no change to tracked fieldsv66
  4. Publications: 5 to 6v65
  5. Trial status: Active, Not Recruiting to Completed
    • Primary completion date: Dec 2009
    v64
  6. Site details revised at 1 of 172 sites
    • Publications: 4 to 5
    v63
  7. Interventions: cytarabine (Drug), daunorubicin hydrochloride (Drug), oblimersen (Biological) to cytarabine (Drug), daunorubicin hydrochloride (Drug), oblimersen sodium (Biological)v62
  8. Interventions: cytarabine (Drug), daunorubicin hydrochloride (Drug), oblimersen (Drug) to cytarabine (Drug), daunorubicin hydrochloride (Drug), oblimersen (Biological)v61
  9. Re-verified, no change to tracked fieldsv60
  10. Interventions: antisense therapy (Procedure), chemosensitization/potentiation therapy (Procedure), chemotherapy (Procedure), cytarabine (Drug)… to cytarabine (Drug), daunorubicin hydrochloride (Drug), oblimersen (Drug)v59
  11. 2 versions Re-verified since Dec 15, 2007, no change to tracked fieldsv57-v58
  12. Interventions: antisense therapy (Procedure), chemosensitization/potentiation (Procedure), chemotherapy (Procedure), cytarabine (Drug), daunorubicin… to antisense therapy (Procedure), chemosensitization/potentiation therapy (Procedure), chemotherapy (Procedure), cytarabine (Drug)…v56
  13. 3 versions Re-verified since Aug 28, 2007, no change to tracked fieldsv53-v55
  14. Enrollment target: 500
    • Start date: Dec 2003
    • Study description expanded, about 18 words
    v52
  15. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 172 of 172 sites
    v51
  16. Study sites: 173 to 172v50
  17. Study sites: 175 to 173v49
  18. Study sites: 174 to 175v48
  19. Study sites: 173 to 174v47
  20. Study sites revised (173)v46
  21. Study sites: 175 to 173v45
  22. Study sites: 173 to 175v44
  23. Study sites: 171 to 173v43
  24. Study sites: 172 to 171v42
  25. Study sites: 168 to 172v41
  26. Study sites: 166 to 168v40
  27. Study sites: 165 to 166v39
  28. Study sites: 171 to 165v38
  29. Study sites: 180 to 171v37
  30. Study sites: 181 to 180v36
  31. Study sites: 182 to 181v35
  32. Re-verified, no change to tracked fieldsv34
  33. Study sites: 181 to 182v33
  34. Study sites: 180 to 181v32
  35. Study sites: 177 to 180v31
  36. Study sites revised (177)v30
  37. Study sites: 179 to 177v29
  38. Study sites: 174 to 179v28
  39. Study sites revised (174)v27
  40. Study sites: 173 to 174v26
  41. Study sites: 178 to 173v25
  • 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 is studying daunorubicin, cytarabine, and oblimersen to see how well they work compared to daunorubicin and cytarabine in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of daunorubicin and cytarabine by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without oblimersen in treating acute myeloid leukemia.
Trial Details
NCT Number NCT00085124
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
Related terms Congenital Abnormalities
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Updated on ClinicalTrials.gov