A Phase 1 Study of CSL362 (Anti-IL3RÎ± / Anti-CD123 Monoclonal Antibody) in Patients with CD123+ Acute Myeloid Leukemia in Complete Remission or Complete Remission with Incomplete Platelet Recovery at High Risk for Early Relapse
B Douglas Smith
CSL362 is a new approach for the treatment of people who have AML. CSL362 is a protein belonging to a relatively new class called â??antibodiesâ??. The CSL362 antibody has been designed to attack AML cells. It has recently been discovered that AML is often not cured because of rare cells called â??leukemic stem cellsâ?? that are not killed by chemotherapy. These cells can be thought of as the â??originâ?? of the leukaemia and only a few of these cells need to survive for the leukaemia to grow back. It is thought that these leukemic stem cells need to be completely destroyed before AML can be cured. The main purpose of this study is to determine how safe and well tolerated CSL362 is in patients who have recently finished their chemotherapy for their AML and are in remission. This study will also determine the amount of CSL362 in the blood and how long it remains in the body after it is given (known as â??pharmacokineticsâ??). Tests will also be conducted on your blood to find out how CSL362 affects leukemia cells and other blood cells and to see whether your body reacts against CSL362.
The main criteria to be eligible to participate in this study are: ï?· Male or female aged 18 years or older. ï?· Previous diagnosis of CD123+ AML, de novo or secondary. ï?· Completed and recovered from all planned induction and consolidation therapy according to the institution's standard of care, and achieved a CR / CRp; either first or second CR. ï?· Has factors conferring high risk of relapse. ï?· No plans for additional post-remission chemotherapy. ï?· Not currently a candidate for allogeneic HSCT. ï?· Must not have diagnosis of acute promyelocytic leukemia (AML M3), t(15;17)(q22;q12); (PML / RARÎ±) and variants excluded. ï?· No known leukemic involvement of the central nervous system. ï?· Life expectancy â?¥ 4 months as estimated by the investigator. ï?· Must not receive concurrent treatment or planned treatment with other anticancer therapy (chemotherapy, immunotherapy, radiotherapy, targeted therapy, gene therapy).
You will be in the study for approximately 16 weeks. However, the Sponsor will ask your study doctor for information on how you are doing 24 weeks after you have received CSL362 for the first time. If you agree to join the study by signing this informed consent form, you will have up to a 2 week screening period. It will be seen during this period whether you meet all of the requirements to participate in this study. If you do meet all requirements for the study, you will receive CSL362 by intravenous infusion once every 14 days over a period of 10 weeks, that is, you will receive, in total, 6 doses of CSL362 during the study.
12/21/2013 04:02 AM