OHSU

IRB #

IRB00010537

Title

A Phase I, Multicenter, Open-Label Study of Oral ABL001 in Patients with Chronic Myelogenous Leukemia or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Principal Investigator

Michael Heinrich

Study Purpose

To test the safety of an investigational study drug at different dose levels among patients with CML or Philadelphia Chromosome-positive ALL.

Medical Condition(s)

Chronic Myelogenous Leukemia (CML); Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (ALL)

Eligibility Criteria

18 years of age with:
- Philadelphia chromosome-positive CML in chronic or accelerated phase previously treated with two different tyrosine kinase inhibitors before study entry and are relapsed, refractory to or intolerant of TKIs as determined by investigators. Patients with CML in blast crisis are excluded from entry onto this study.
-Philadelphia chromosome-positive ALL that is relapsed or refractory to one prior TKI or who are intolerant of TKIs.

Age Range

18 - 101

Healthy Volunteers Needed

No

Duration of Participation

You can be in the study until any of the following happens:
• The investigator decides your cancer condition is worse or thinks you should stop taking the study drug
• You decide you want to stop receiving the treatment
• You experience side effects from the study drugs that you find unacceptable
• The Investigator thinks that keeping you in the study might be harmful to you
• You need a health treatment not allowed in this study
• You do not follow the study instructions
• You become pregnant
• Novartis decides to stop the study
• You have unexpected events that effect your health and safety

Minors Included

No

Contact

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

Sponsor

Novartis Pharmaceutical Corporation

Recruitment End

01/01/2025

Compensation Provided

No


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