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

NCT02467270 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 283

Last updated 2026-03-17

Study results available
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Summary

The purpose of this study is to characterize the efficacy of ponatinib administered in 3 starting doses (45 mg, 30 mg, and 15 mg daily) in participants with CP-CML who are resistant to prior tyrosine-kinase inhibitor (TKI) therapy or have T315I mutation, as measured by \<=1 % Breakpoint Cluster Region-Abelson Transcript Level using International Scale (BCR-ABL1IS) at 12 months.

Conditions

  • Myeloid Leukemia, Chronic, Chronic Phase

Interventions

DRUG

Ponatinib

Tablet, taken orally once daily.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-13
Primary Completion
2020-04-29
Completion
2025-04-23
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Chile
  • Czechia
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Italy
  • Poland
  • Portugal
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02467270 on ClinicalTrials.gov