OHSU

IRB #

IRB00007195

Title

A Phase II Proof of Concept Trial to Study Kinase Inhibition in Relapsed/Refractory Acute Leukemias: Using a Comprehensive in Vitro Kinase Inhibitor Panel to Select Individualized Targeted Therapies

Principal Investigator

Stephen Spurgeon

Study Purpose

This study is being done to identify treatments that may be effective against certain types of leukemia. The study drug that each subject receives will be determined by a test developed by OHSU that may help determine which drug might be most effective for his or her leukemia. This is called “targeted therapy." In this study, we are trying to find out if this new screening lab test can help us provide individualized treatment for patients with leukemia and evaluate how the leukemia responds.

Medical Condition(s)

Acute Lymphoblastic Leukemia (ALL) or Acute Myelogenous Leukemia (AML)

Eligibility Criteria

This study is overall for patients who are 21 years of age or greater with relapsed or refractory Acute Myeloid Leukemia (AML) or have relapsed or refractory Acute Lymphoblastic Leukemia (ALL). Some primary eligibility specifics are the following:

*If you are 70 years old or older: you must have had no response to initial therapy or relapsed less than a 1 year after induction, or, if you have relapsed after 1 year but have no response to at least 1 cycle of salvage therapy.

*If you are the age of 21-69: you must have relapsed and have no response to at least 1 cycle of salvage therapy.

*Must be able to take oral medication

*Have not received leukemia treatment within 2 weeks of starting study drug

Age Range

21 - 99

Healthy Volunteers Needed

No

Duration of Participation

The study drug is guaranteed at no-cost for 1 cycle (28 days). If the subject is sensitive to the study drug, the subject may continue the study drug.

Minors Included

No

Contact

Nan Subbiah, 503-494-4603, subbiahn@ohsu.edu

Sponsor

OHSU

Recruitment End

Compensation Provided

No


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