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Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 4 to 5v9
  2. Eligibility criteria expanded, about 24 words Study description shortened, about 23 words · Study title shortened, about 7 words · Study arms: 3 to 4v8 Show 3 more changesShow less
    • Study description shortened, about 23 words
    • Study title shortened, about 7 words
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv7
  4. Interventions: Asciminib (Drug), Imatinib (Drug) to Asciminib 40 MG (Drug), Asciminib 40 MG Twice Daily (Drug), Asciminib 80 MG daily (Drug), Dasatinib (Drug), Imatinib (Drug), Nilotinib… Eligibility criteria expanded, about 116 words · Study description shortened, about 46 words · Study arms: 1 to 3 · 1 morev6 Show 4 more changesShow less
    • Eligibility criteria expanded, about 116 words
    • Study description shortened, about 46 words
    • Study arms: 1 to 3
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 2 to 4v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 1 to 2 Eligibility criteria expanded, about 65 wordsv4 Show 1 more changeShow less
    • Eligibility criteria expanded, about 65 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 30, 2021 to Nov 11, 2021 · Site details revisedv3 Show 2 more changesShow less
    • Start date changed from estimate of Sep 30, 2021 to Nov 11, 2021
    • Site details revised
  3. Start date: Jun 2021 to Sep 30, 2021v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI). All patients must have restarted the same TKI they were on prior to discontinuation at the time of relapse in order to be eligible for this trial.
Trial Details
NCT Number NCT04838041
Lead Sponsor Medical College of Wisconsin
Collaborators: H. Jean Khoury Cure CML Consortium
Conditions Chronic Phase Chronic Myelogenous Leukemia
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov