Intensified Post Remission Therapy Containing PEG-Asparaginase
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
This study is for patients with recently diagnosed blood cancer, called acute lymphoblastic
leukemia (ALL). The standard treatment for this disease consists of many chemotherapy drugs
that are given in different combinations in several steps. Each step of treatment is called a
cycle. Patients will be treated with the chemotherapy drugs that are routinely used in ALL
and which are given in multiple treatment cycles over several months. All the chemotherapy
drugs that are used in this study have been approved by the Food and Drug Administration
(FDA).
One of the drugs, which is typically given to patients with ALL, is called Asparaginase. It
is given together with the other drugs throughout the different cycles of treatment. This
drug can be derived from several sources. The standard source is called E. coli Asparaginase,
which is associated with a risk of allergic reactions. This drug stays in the body for a very
short period of time; therefore, it has to be injected daily for 9-14 days in a cycle of
treatment.
In this study, a different form of Asparaginase will be used, called PEG-Asparaginase (also
called Oncospar), which remains in the body for about two weeks, therefore, it can be given
only once in a cycle of treatment and still maintains high blood levels of the drug.
PEG-Asparaginase has recently been approved by the FDA to treat ALL. Most of the experience
with the drug has been in children with ALL. In children it was found to be as safe as the
standard form of Asparaginase and with less allergic reaction. It was also found to have the
same effectiveness on ALL. The experience with this drug in adults has been more limited.
The purpose of the study is to find out what side effects occur in adults when
PEG-Asparaginase is given with other chemotherapy drugs and to see what effect it has on the
response to treatment of ALL. Another purpose is to find out if the allergic reactions are
reduced with PEG-Asparaginase. In children there is some early information that
PEG-Asparaginase produces fewer antibodies than E.coli Asparaginase. Therefore, another
purpose of the study is to see how many adult patients who receive PEG-Asparaginase develop
antibodies against the drug.