Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia

StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Enrollment increased: 52 → 72 participants Show 4 more changesShow less
    • Eligibility criteria shortened, about 10 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Study description revised
    • Publications: details revised at 1 of 1 entry
  2. 16 versions Re-verified since Nov 29, 2023, no change to tracked fieldsv25-v40
  3. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2026v24
  4. Primary and study completion dates: Dec 31, 2023 to Dec 31, 2024v23
  5. 5 versions Re-verified since Apr 12, 2023, no change to tracked fieldsv18-v22
Show 16 earlier versionsHide 16 earlier versions
  1. Primary and study completion dates: Dec 31, 2022 to Dec 31, 2023v17
  2. Re-verified, no change to tracked fieldsv16
  3. Primary and study completion dates: Jun 30, 2022 to Dec 31, 2022v15
  4. Primary completion date: Jun 30, 2021 to Jun 30, 2022v14
  5. 2 versions Re-verified since Apr 27, 2021, no change to tracked fieldsv12-v13
  6. Eligibility criteria expanded, about 18 words
    • Study description expanded, about 7 words
    • Site contact updated
    • Collaborators shortened, about 4 words
    v11
  7. Re-verified, no change to tracked fieldsv10
  8. Primary completion date: Jun 30, 2020 to Jun 30, 2021
    • Study completion date: Jun 30, 2020 to Jun 30, 2022
    v9
  9. 3 versions Re-verified since Jul 15, 2019, no change to tracked fieldsv6-v8
  10. Primary endpoints revised (2)v5 Show 4 more changesShow less
    • Enrollment target: 46 to 52
    • Eligibility criteria expanded, about 16 words
    • Study description expanded, about 20 words
    • Site contact updated
  11. Primary and study completion dates: Jun 2020 to Jun 30, 2020v4
  12. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 31, 2019 to Oct 29, 2018
    • Site details revised
    v3
  13. Primary and study completion dates: Jun 30, 2020 to Jun 2020v2
  1. Study First Submitted
  • 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 II trial studies how well liposome-encapsulated daunorubicin-cytarabine and venetoclax work in treating participants with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or has not been treated (untreated). Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine and venetoclax, 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.
Trial Details
NCT Number NCT03629171
Lead Sponsor M.D. Anderson Cancer Center
Conditions
(from sponsor)		 Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov