IRB #

STUDY00017418

Title

A Phase 3, Multi-Center, Open-Label Randomized Study of Oral Asciminib Versus Bosutinib in Patients with Chronic Myelogenous Leukemia in Chronic Phase (CML-CP), Previously Treated with 2 or more Tyrosine Kinase Inhibitors

Principal Investigator

Michael Heinrich

Study Purpose

The purpose of this study is to compare the benefits and side effects of ABL001 versus bosutinib in patients with CML in chronic phase.

Medical Condition(s)

Chronic Myelogenous Leukemia in chronic phase (CML-CP)

Eligibility Criteria

- Men and women at least 18 years of age
- Clinically diagnosed with CML
- Have previously been treated with at least two tyrosine kinase inhibitors (TKIs), such as imatinib, nilotinib, dasatinib, radotinib or ponatinib
- No previous treatment with a hematopoietic stem-cell transplantation

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Participants will receive study treatment for up to 3 years. After you finish the study treatment, the investigator will continue to watch you for side effects and follow your condition for up to 5 years from the date the last patient received the first study dose.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Novartis

Recruitment End

01/01/2022

Compensation Provided

No


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