IRB #

STUDY00018659

Title

A Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia (Ph+ ALL)

Principal Investigator

Jessica Leonard

Study Purpose

This study is being done to answer the following question:

Is ponatinib more effective than imatinib in patients with Acute Lymphoblastic Leukemia (ALL)?

Medical Condition(s)

Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL)

Eligibility Criteria

-Age 18 or older
-You have been newly diagnosed with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL)

Age Range

18 - n/a

Healthy Volunteers Needed

No

Duration of Participation

The duration that you will take study drug or imatinib will depend on your response and tolerance to the drug you are receiving. You may stop receiving either study drug or imatinib if you will undergo stem-cell transplantation. After you stop taking the study drug, you will be followed to see if you are alive and well, and to assess the status of your disease. For this survival follow-up, you will be contacted every 3 months (+/- 14 days) until death has been reported.

Your investigator will assess your individual response to the study drug and your participation may be longer or shorter than the estimated average.

Minors Included

No

Contact

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

Sponsor

Millenium Pharmaceuticals, Inc (A wholly owned subsidiary of Takeda Pharmaceutical Company Limited)

Recruitment End

01/01/2028

Compensation Provided

No


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