NCT02627677

A Study Comparing Ponatinib and Nilotinib in Participants With Chronic Myeloid Leukemia

A Randomized, Open-label Study of Ponatinib Versus Nilotinib in Patients With Chronic Myeloid Leukemia in Chronic Phase Following Resistance to Imatinib

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Ariad Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the efficacy and safety of 2 starting doses of ponatinib compared to nilotinib in participants with imatinib-resistant chronic myeloid leukemia (CML) in chronic phase (CP).

Detailed description

This is a multi-center, randomized study to demonstrate the efficacy and safety of 2 starting doses of ponatinib as a treatment for CP-CML compared to nilotinib. Eligible participants must have chronic phase chronic myeloid leukemia (CP-CML), be resistant to first-line imatinib treatment and have received no other tyrosine kinase inhibitors (TKIs).

Conditions

• Chronic Phase Chronic Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Ponatinib 30 mg QD	Ponatinib 30 mg, taken orally once daily.
DRUG	Ponatinib 15 mg QD	Ponatinib 15 mg, taken orally once daily.
DRUG	Nilotinib 400 mg BID	Nilotinib 400 mg, taken orally twice daily.

Timeline

• Start date: 2015-12-31
• Primary completion: 2020-10-29
• Completion: 2021-01-20
• First posted: 2015-12-11
• Last updated: 2021-11-26
• Results posted: 2021-11-26

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study