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Adding Asciminib to Usual Treatment for Adults With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia

StatusEnrolling by Invitation
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 11 → 16 locations Eligibility criteria expanded, about 33 words · Secondary endpoints: details revised at 10 of 14 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints: details revised at 10 of 14 entries
  2. Study sites: 10 to 11v8
  3. Study sites: 8 to 10 Start date changed from estimate of May 15, 2026 to Apr 13, 2026v7 Show 1 more changeShow less
    • Start date changed from estimate of May 15, 2026 to Apr 13, 2026
  4. Study sites: 6 to 8v6
  5. Start date: Mar 15, 2026 to May 15, 2026 Study sites: 2 to 6v5 Show 1 more changeShow less
    • Study sites: 2 to 6
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Enrolling by Invitation Start date: Jul 15, 2025 to Mar 15, 2026 · Study sites: 0 to 2v4 Show 2 more changesShow less
    • Start date: Jul 15, 2025 to Mar 15, 2026
    • Study sites: 0 to 2
  2. Start date: May 15, 2025 to Jul 15, 2025v3
  3. Start date: Mar 31, 2025 to May 15, 2025 Primary completion date: Mar 2029 to May 2029 · Completion date: May 2033 to Jul 2033 · Eligibility criteria shortened, about 4 wordsv2 Show 3 more changesShow less
    • Primary completion date: Mar 2029 to May 2029
    • Completion date: May 2033 to Jul 2033
    • Eligibility criteria shortened, about 4 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 II trial is to answer the question of "can adding the study drug, asciminib to usual treatment improve how chemotherapy works against Ph+ Acute Lymphoblastic Leukemia (ALL) and is this approach better than the usual approach for Ph+ALL?"
Trial Details
NCT Number NCT06773936
Lead Sponsor SWOG Cancer Research Network
Collaborators: Novartis Pharmaceuticals
Conditions Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia, CD19+ Acute Leukemia
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov