Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses

  • STATUS
    Not Recruiting
  • participants needed
    276
  • sponsor
    Ariad Pharmaceuticals
Updated on 20 June 2021

Summary

The purpose of this study is to characterize the efficacy and safety of ponatinib in participants with resistant chronic myeloid leukemia (CML) in chronic phase (CP) in a range of doses.

Description

The drug being tested in this study is ponatinib. This study will characterize the safety and efficacy of ponatinib over a range of 3 starting doses.

The study will enroll 276 participants in 3 cohorts and each cohort will have 92 participants. All the participants will be randomized to receive once-daily oral administration of 1 of 3 starting doses of ponatinib:

Cohort A: 45 mg ponatinib tablet Cohort B: 30 mg ponatinib tablet Cohort C: 15 mg ponatinib tablet

The study is designed to consist of 2 periods: 24-cycle Main treatment period and optional treatment continuation period. Participants will be treated with their randomized dose of study drug in the Main Treatment Period until the occurrence of at least one of the following: absence of complete hematologic response (CHR) by 3 months, absence of MCyR at 12 months, absence of <= 1% BCR-ABL1IS at 12 months, loss of <= 1% BCR-ABL1IS development of intolerance, or completion of all 24 cycles of treatment (whichever occurs first). Following completion of the 24-month main treatment period or following early withdrawal, participants may enter into an optional treatment continuation period.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 60 months. Participants will make a final visit to the clinic approximately 30 days after the last dose of study treatment.

Details
Condition chronic phase chronic myelogenous leukemia
Treatment ponatinib 45 mg, ponatinib 30 mg, ponatinib 15 mg
Clinical Study IdentifierNCT02467270
SponsorAriad Pharmaceuticals
Last Modified on20 June 2021

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