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A Study of Olverembatinib in Patients With Newly Diagnosed Ph+ ALL (POLARIS-1)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 31, 2024 to Dec 31, 2027 Primary endpoint revised · Study sites: 14 to 90 · Completion date: Oct 31, 2028 to Jun 30, 2029 · 6 morev6 Show 9 more changesShow less
    • Primary endpoint revised
    • Study sites: 14 to 90
    • Completion date: Oct 31, 2028 to Jun 30, 2029
    • Interventions: Imatinib (Drug), Olverembatinib (Drug) to Investigator's choice of TKI (Drug), Olverembatinib (Drug)
    • Eligibility criteria shortened, about 114 words
    • Secondary endpoints: 3 to 4
    • Collaborator revised
    • Study description expanded, about 3 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 10 to 14v5
  3. Study sites: 9 to 10v4
  4. Start date: Sep 2, 2023 to Aug 31, 2023v3
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 31, 2023 to Sep 2, 2023 · Secondary endpoints revised (3) · Site details revised at 9 of 9 sitesv2 Show 3 more changesShow less
    • Start date changed from estimate of Oct 31, 2023 to Sep 2, 2023
    • Secondary endpoints revised (3)
    • Site details revised at 9 of 9 sites

    See this version in full on ClinicalTrials.gov ↗

  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of olverembatinib combined with chemotherapy versus investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in subjects with newly-diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).
Trial Details
NCT Number NCT06051409
Lead Sponsor Ascentage Pharma Group Inc.
Collaborators: Guangzhou Healthquest Pharma Co., Ltd
Conditions Ph+ ALL, Leukemia, Lymphoblastic, Acute, Philadelphia-Positive
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov