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DC/AML Fusion Cell Vaccine vs Observation in Patients Who Achieve a Chemotherapy-induced Remission

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 4, 2026 → Dec 4, 2026
See other at-risk trials from Beth Israel Deaconess Medical Center

Record History

  1. Primary completion pushed from Sep 4, 2026 to Dec 4, 2026 Completion pushed from Dec 4, 2026 to Jun 4, 2027 · Interventions: DC/AML Fusion Vaccine (Biological), Observation (Other) to DC/AML Fusion Vaccine (Biological), Observation (Other) · Eligibility criteria expanded, about 41 words Show 3 more changesShow less
    • Completion pushed from Dec 4, 2026 to Jun 4, 2027
    • Interventions: DC/AML Fusion Vaccine (Biological), Observation (Other) to DC/AML Fusion Vaccine (Biological), Observation (Other)
    • Eligibility criteria expanded, about 41 words
  2. Primary completion date: Dec 4, 2023 to Sep 4, 2026v16
  3. Trial status: Completed to Active, Not Recruiting Completion date: Sep 23, 2024 to Dec 4, 2026v15 Show 1 more changeShow less
    • Completion date: Sep 23, 2024 to Dec 4, 2026
  4. Trial status: Recruiting to Completed Enrollment target: estimated 75 to confirmed 82 · Study sites: 6 to 4 · Primary completion date changed from estimate of May 31, 2025 to Dec 4, 2023 · 1 morev14 Show 4 more changesShow less
    • Enrollment target: estimated 75 to confirmed 82
    • Study sites: 6 to 4
    • Primary completion date changed from estimate of May 31, 2025 to Dec 4, 2023
    • Study completion date changed from estimate of Aug 31, 2025 to Sep 23, 2024
  5. Lead sponsor: Dana-Farber Cancer Institute to Beth Israel Deaconess Medical Center Collaborators: 1 to 2v13 Show 1 more changeShow less
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 5 to 6v12
  2. Primary completion date: Oct 30, 2024 to May 31, 2025 Completion date: Feb 28, 2025 to Aug 31, 2025v11 Show 1 more changeShow less
    • Completion date: Feb 28, 2025 to Aug 31, 2025
  3. Primary completion date: Oct 30, 2021 to Oct 30, 2024 Completion date: Oct 30, 2023 to Feb 28, 2025v10 Show 1 more changeShow less
    • Completion date: Oct 30, 2023 to Feb 28, 2025
  4. Primary completion date: Sep 30, 2021 to Oct 30, 2021 Completion date: Sep 30, 2024 to Oct 30, 2023v9 Show 1 more changeShow less
    • Completion date: Sep 30, 2024 to Oct 30, 2023
  5. Site details revised at 1 of 5 sitesv8
  6. Primary completion date: Sep 30, 2020 to Sep 30, 2021 Enrollment target: 105 to 75 · Study sites: 4 to 5 · Eligibility criteria expanded, about 25 wordsv7 Show 3 more changesShow less
    • Enrollment target: 105 to 75
    • Study sites: 4 to 5
    • Eligibility criteria expanded, about 25 words

    See this version in full on ClinicalTrials.gov ↗

  7. Study sites: 3 to 4v6
  8. Re-verified, no change to tracked fieldsv5
  9. Interventions: DC/AML Fusion Vaccine (Biological), Durvalumab (Drug), Observation (Other) to DC/AML Fusion Vaccine (Biological), Observation (Other) Eligibility criteria shortened, about 26 words · Study description shortened, about 65 words · Site details revised at 1 of 3 sites · 2 morev4 Show 5 more changesShow less
    • Eligibility criteria shortened, about 26 words
    • Study description shortened, about 65 words
    • Site details revised at 1 of 3 sites
    • Study title shortened, about 7 words
    • Study arms: 3 to 2

    See this version in full on ClinicalTrials.gov ↗

  10. Re-verified, no change to tracked fieldsv3
  11. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Mar 31, 2017 to Jun 1, 2017 · Site details revised at 3 of 3 sitesv2 Show 2 more changesShow less
    • Start date changed from estimate of Mar 31, 2017 to Jun 1, 2017
    • Site details revised at 3 of 3 sites
  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 research study is studying a cancer vaccine called Dendritic Cell/AML Fusion vaccine (DC/AML vaccine) as a possible treatment for Acute Myelogenous Leukemia (AML). The interventions involved in this study are: -Dendritic Cell/AML Fusion vaccine (DC/AML vaccine)
Trial Details
NCT Number NCT03059485
Lead Sponsor Beth Israel Deaconess Medical Center
Collaborators: Celgene, Dana-Farber Cancer Institute
Conditions Acute Myelogenous Leukemia
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov