The Study for CML Who Failed Prior TKIs or With T315I Mutation or Ph+ ALL Who Failed Prior TKIs or With T315I Mutation

StatusCompleted
PhasePhase 2
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study completion date changed from estimate of Dec 31, 2025 to Sep 8, 2026
    • Trial completed
    • Eligibility criteria expanded, about 46 words
    • Site details revised at 1 of 14 sites
  2. Enrollment target: estimated 90 to confirmed 93
    • Interventions: Ponatinib (Drug) to Ponatinib 30mg OD (Drug), Ponatinib 45mg OD (Drug)
    • Study arms: 1 to 2
    v8
  3. Primary completion date changed from estimate of Oct 31, 2021 to Jul 22, 2022
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 14 of 14 sites
    v7
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 31, 2020 to Jul 9, 2020
    • Site details revised at 14 of 14 sites
    v6
  5. Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Apr 30, 2020 to Jul 31, 2020v4
  2. Start date: Jan 31, 2020 to Apr 30, 2020v3
  3. Secondary endpoints: details revised at 1 of 7 entriesv2
  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 protocol will allow ponatinib with refractory Chronic Myeloid Leukemia or Ph+ Acute Lymphoblastic Leukemia
Trial Details
NCT Number NCT04233346
Lead Sponsor Otsuka Beijing Research Institute
Conditions
(from sponsor)		 Chronic Myeloid Leukemia, Acute Lymphoblastic Leukemia
Related terms Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 93 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov