Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04070443 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Safety and Efficacy of Ponatinib Followed by Imatinib in Patients With Chronic Myelogenous Leukemia in Chronic Phase

Study acronym: TIPI
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites revised (28)v17
  2. 4 versions Re-verified since Dec 15, 2022, no change to tracked fieldsv13-v16
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 28 of 28 sites
    v12
  4. Primary and study completion dates: Jun 1, 2027 to Jun 1, 2029
    • Site contacts updated at 2 of 28 sites
    • Eligibility criteria shortened, about 2 words
    v11
  5. Eligibility criteria shortened, about 2 wordsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 27 to 28v9
  2. Study sites: 25 to 27v8
  3. Study sites: 11 to 25v7
  4. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 11 of 11 sites
    v6
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 11 of 11 sites
    v5
  6. Study sites: 5 to 11v4
  7. Study sites: 2 to 5v3
  8. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Oct 1, 2019 to Nov 13, 2019
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The investigators hypothesize that, in newly diagnosed de novo chronic phase CML patients, an induction treatment with ponatinib for 6 months should increase the rate of patients reaching a stable MR4.5 allowing cessation of imatinib treatment. The investigators proposal is to conduct a multicenter, Phase II trial to evaluate the safety, clinical and biological activity of an induction treatment with ponatinib for 6 months, followed by a consolidation treatment with imatinib in newly diagnosed de novo chronic phase CML patients.
Trial Details
NCT Number NCT04070443
Lead Sponsor Centre Leon Berard
Conditions
(from sponsor)		 Philadelphia Chromosome Positive CML, BCR-ABL Positive Chronic Myelogenous Leukemia
Related terms Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov