Title:
A Phase 1/2 Safety and Efficacy Study of Orally Administered PLX3397 in Adults With Relapsed or Refractory Flt3-ITD positive Acute Myeloid Leukemia
Protocol Number:
J1165
Phase:
Phase I/II
Physician:
Mark Levis
Purpose:
You may be interested in learning about a new clinical trial at Johns Hopkins called Plexxikon, which tests a type of drug called a FLT-3 inhibitor for relapsed or refractory AML patients. In part 1 of this study, we will test the drug for the maximum tolerated dose and for dose-limiting toxicities. In part 2 of the study, we will test whether the drug can help prolong survival and achieve complete remissions in relapsed or refractory AML patients.
Eligibility:
To join the Plexxikon study, you must have relapsed or refractory AML and have a known mutation in the FLT-3 gene. In general, this testing is first done when AML is diagnosed, so your doctor may already be aware of your mutation status. Mutations in this gene and their faulty protein products can be found in up to 40 percent of AML patients and are characterized by aggressive disease. Additionally, you must have adequate liver and kidney function, as well as a good performance status (meaning, you can perform activities of daily living by yourself). To see if you are eligible to take part in this study, you must first sign a consent form to be screened. Then, during screening, a medical history will be taken, a physical exam will be done, and all of your current medications will be reviewed.
Treatment:
Treatment: In this new study, patients will receive a twice-daily dosing of an oral drug (a capsule) for 28 day cycles. On Day 1, Day 2, and Day 15 of the first cycle only, patients will visit the clinic to undergo testing (including blood samples, EKG, physical exam, and vital signs) and receive their drug. On all other days, patients will take the drug twice daily at home. The patient will then visit the clinic on Day 1 of every subsequent cycle to undergo the testing as mentioned above. Please note that in most cases, this study also requires monthly bone marrow biopsies. Even when you have completed the study, we will continue to follow you indefinitely to monitor your leukemia and your survival. This may be done by clinic visits to your doctor, by obtaining notes and lab reports from your local doctor, and/or telephone or email contact with yourself. This contact will occur every 3 months for at least 2 years. If you have questions about your eligibility for this study, please contact your Johns Hopkins physician.
Population:
Adult
Last Update
05/19/2013 04:02 AM
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