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

NCT02627677 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-11-26

Study results available
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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).

Conditions

  • Chronic Phase Chronic Myeloid Leukemia

Interventions

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.

Sponsors & Collaborators

  • Ariad Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Study 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
2015-12-31
Primary Completion
2020-10-29
Completion
2021-01-20
FDA Drug
Yes

Countries

  • Belgium

Study Locations

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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 NCT02627677 on ClinicalTrials.gov