POETIC10-03: A Phase I Study Using Plerixafor as a Chemosensitizing Agent for Relapsed Acute Leukemia and MDS in Pediatric Patients
This research study is being done to test the safety of an investigational study drug called plerixafor in people with Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), or Acute Leukemia of Ambiguous Lineage (MPAL) that has relapsed or is not responding to treatment. The study will also look at the effect of plerixafor on the leukemia or myelodysplastic syndrome. Plerixafor is a drug that blocks a receptor on the leukemia cell. Plerixafor prevents this cell from staying in the bone marrow where it can be resistant to chemotherapy (cancer fighting drugs). By mobilizing the stem cells from the bone marrow, we hope to make them more sensitive to our standard chemotherapies.
To be in this study, you must have ALL, AML, MDS, or MPAL that has relapsed (came back after treatment) or is not responding to treatment.
In this study plerixafor will be used together with other drugs: cytarabine and etoposide. Cytarabine and etoposide have been used as part of standard, FDA approved chemotherapy for relapsed ALL. This is a Phase I study. Phase I studies start using the study drugs at low doses and slowly increase the amounts of the study drugs that are given to people until the side effects of the drugs are too high to give more. This means that not all people in the study will get the same dose of plerixafor . Doses at the beginning of the study will be lower than doses at the end of the study. Because of the design of the study, some people may get doses that are too low to have an effect, and other people will probably get doses that cause side effects. You will receive the study drugs during two 28-day periods. This 28-day period is called a cycle. All drugs will be given IV.
05/21/2013 04:02 AM