Title:
A Phase I Study of AC220 (A2689) in Combination with Induction and Consolidation Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia
Protocol Number:
J1123
Phase:
Phase I
Physician:
Keith Pratz
Purpose:
You may be interested in learning about a new clinical trial at Johns Hopkins called Astellas. In this trial, we are giving AC220 with the standard chemotherapy (daunorubicin and cytarabine) for AML to learn about its side effects and toxicities, and to see if we can improve a chance of getting a remission, as well as improve the chance that patients who receive it will eventually be cured.
Eligibility:
To join the study, you must have AML, and have received NO prior treatment for your AML. You must be between 18 and 60 years old. Subjects with both a positive and negative FLT3-ITD mutation status are eligible. 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. Exclusion criteria: You cannot join this study if you have any of the following: â?¢acute promyelocytic leukemia (APL) â?¢chronic myelogenous leukemia (CML) in blast crisis â?¢CNS leukemia â?¢HIV â?¢Hepatitis B or C â?¢Having uncontrolled or significant cardiovascular disease MAY make you ineligible. You must talk with your doctor about this. This includes, but is not limited to: o recent heart attack oangina oCHF oheart block ouncontrolled high blood pressure opacemaker oatrial fibrillation â?¢Also, if you are female, you cannot be lactating or pregnant.
Treatment:
In this Phase 1 study, AC220 will be given in combination with two other chemotherapy drugs: daunorubicin and cytarabine. Both of these chemotherapy agents are used to treat patients with newly diagnosed AML and other types of leukemia. Daunorubicin and cytarabine are FDA approved drugs. This study will be the first study where AC220 is given in combination with other drugs. AC220 is a liquid drug that is given by mouth. There are two dosing phases that patients will receive: Induction and Consolidation. You will be hospitalized while receiving study drug and for monitoring during the Induction phase. You will be hospitalized during Consolidation, and may be kept in the hospital during recovery between cycles if that is what your study doctor determines is best for you. During the Induction phase, you will receive IV daunorubicin and cytarabine. On Day 4, the assigned dose of AC220 will be added to the study drug regimen. You will receive AC220 for either 7 or 14 days, depending on your dose assignment. If remission is achieved, you will begin Consolidation where you will receive high-dose cytarabine and AC220. Consolidation is given as 3 repeated cycles of Cytarabine and AC220. On Day 4 of consolidation, AC220 will be added to the study drug plan and will be given every day for either 7 or 14 days (depending on your dose assignment). If you are discharged from the hospital during Consolidation, you may need to self-administer AC220 at home and keep a diary of when you take AC220. Throughout your time on the study, you will have medication, treatment, and transfusion review, adverse event assessments, physical exams, EKGs, vital sign assessments, blood sample collection for routine blood tests (including hematology, chemistry, and coagulation), urine sample collection for routine laboratory measurements and pregnancy tests for females of child bearing potential, and bone marrow aspirate and/or biopsy. You will also have study-specific research blood samples taken. If you have questions about your eligibility for this study, please contact your Johns Hopkins physician.
Population:
Adult
Last Update
05/22/2013 04:02 AM
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