ONCASPAR®, the ENZON trademark for pegaspargase, is a modified version of the enzyme L-asparaginase. It is an oncolytic agent used in combination chemotherapy for the treatment of patients with acute lymphoblastic leukemia who are hypersensitive to native forms of L-asparaginase (as described in CLINICAL PHARMACOLOGY).
ONCASPAR® is indicated for patients with acute lymphoblastic leukemia who require L-asparaginase in their treatment regimen, but have developed hypersensitivity to the native forms of L-asparaginase (CLINICAL PHARMACOLOGY). ONCASPAR®, like native L-asparginase, is generally used in combination with other chemotherapeutic agents, such as vincristine, methotrexate, cytarabine, daunorubicin, and doxorubicin.1,5 Use of ONCASPAR® as a single agent should only be undertaken when multi-agent chemotherapy is judged to be inappropriate for the patient.
Published Studies Related to Oncaspar (Pegaspargase)
A pharmacoeconomic analysis of pegaspargase versus native Escherichia coli L-asparaginase for the treatment of children with standard-risk, acute lymphoblastic leukemia: the Children's Cancer Group study (CCG-1962). [2002.03]
PURPOSE: The purpose of this pharmacoeconomic analysis was to compare pegaspargase. a newer chemotherapeutic agent used for treating acute lymphoblastic leukemia, with native Escherichia coli L-asparaginase in induction, delayed intensification 1 and delayed intensification 2... CONCLUSION: We recommend that pegaspargase not be withheld from treatment protocols solely because of its higher pharmacy costs.
Insulin infusion to treat severe hypertriglyceridemia associated with pegaspargase therapy: a case report. [2011.03]
We describe a pediatric patient with acute leukemia who developed an uncommon but significant metabolic consequence of pegaspargase therapy-severe hypertriglyceridemia (hyperTG). We also relate our experience with continuous insulin infusion treatment for pegaspargase-induced hyperTG... Our review of the literature suggests that apolipoprotein E polymorphism may influence the development of hyperlipidemia in acute lymphoblastic leukemia patients receiving asparaginase therapy and may identify patients at high risk for developing asparaginase-induced hyperTG.
FDA drug approval summary: pegaspargase (oncaspar) for the first-line treatment of children with acute lymphoblastic leukemia (ALL). [2007.08]
On July 24, 2006, the U.S. Food and Drug Administration granted approval to pegaspargase (Oncaspar; Enzon Pharmaceuticals, Inc., Bridgewater, NJ; hereafter, O) for the first-line treatment of patients with acute lymphoblastic leukemia (ALL) as a component of a multiagent chemotherapy regimen...
Pharmacodynamics and safety of intravenous pegaspargase during remission induction in adults aged 55 years or younger with newly diagnosed acute lymphoblastic leukemia. [2007.04.01]
In contrast to that in children, pharmacokinetic, pharmacodynamic, and safety information on pegaspargase in adults is very limited. We administered a single intravenous dose of pegaspargase (2000 IU/m2) as part of a standard frontline induction regimen to 25 adults with newly diagnosed acute lymphoblastic leukemia (ALL), and obtained serum samples on several time points...
Pegaspargase: a review of clinical studies. [2003.09.26]
The chemotherapy agent L-asparaginase has been an important part of acute lymphoblastic leukemia therapy for over 30 years. Two of the main disadvantages of the drug are (1) the need for frequent intramuscular injection and (2) a very high rate of allergic reactions... In the review below, we outline the history of therapy with L-asparaginase, the development of PEG-L-asparaginase, and clinical trials in which it has been administered.
Clinical Trials Related to Oncaspar (Pegaspargase)
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase [Recruiting]
The purpose of this study is to investigate if intramuscular PEG-asparaginase administered
either at six or two week intervals from day 92 until 8 months from diagnosis for patients
with non-HR ALL will result in equal probability of Event Free Survival
SC-PEG Asparaginase vs. Oncaspar in Pediatric Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma [Recruiting]
This study is being conducted to learn about the effects of SC-PEG, which is a new form of a
chemotherapy drug called asparaginase. Asparaginase is used to treat ALL and lymphoblastic
lymphoma. The standard form of asparaginase, called Elspar, is given in the muscle once a
week for 30 weeks. There are other forms of asparaginase. The investigators will be studying
two of these: Oncaspar and Calaspargase Pegol (SC-PEG). The investigators have previously
studied giving Oncaspar in the vein (instead of the muscle) every 2 weeks in patients with
ALL, and have shown that this dosing did not lead to any more side effects than Elspar given
weekly in the muscle. The study drug, SC-PEG, is very similar but not identical to Oncaspar.
SC-PEG has been given in the vein to children and adolescents with ALL as part of other
research studies, and it appears to last longer in the blood after a dose than Oncaspar. It
has not yet been approved by the FDA. The goal of this research study is to learn whether
the side effects and drug levels of SC-PEG given in the vein every 3 weeks are similar to
Oncaspar given into the vein about every 2 weeks.
The study will also help to determine whether changing treatment for children and
adolescents with ALL with high levels of minimal residual disease may improve cure rates.
Measuring minimal disease (MRD) is a laboratory test that finds low levels of leukemia cells
that the investigators cannot see under the microscope. In the past, it has been shown that
children and adolescents with ALL with high levels of MRD after one month of treatment are
less likely to be cured than those with low levels of MRD. Therefore, on the study, the bone
marrow and blood at the end of the first month of treatment will be measured in participants
with leukemia, and changes in therapy will be implemented based on this measurement. It is
not known for sure that changing treatment will improve cure rates. MRD levels can only be
measured if the marrow is filled with cancer cells at the time of diagnosis. Therefore, MRD
studies will only be done in children and adolescents with ALL and not in those with
Another part of the study is to determine whether giving antibiotics during the first month
of treatment even to participants without fever will prevent serious infections in the blood
and other parts of the body. About 25% of children and adolescents with ALL and
lymphoblastic lymphoma who receive standard treatment develop a serious blood infection from
a bacteria during the first month of treatment. Typically, antibiotics (medicines that fight
bacteria) are given by vein only after a child with leukemia or lymphoma develops a fever or
have other signs of infection. In this study, antibiotics will be given by mouth or in the
vein to all participants during the first month of treatment, whether or not they develop
Another goal of the study to learn how vitamin D levels relate to bone problems (such as
broken bones or fractures) that children and adolescents with ALL and lymphoblastic lymphoma
experience while on treatment. Some of the chemotherapy drugs used to treat ALL and
lymphoblastic lymphoma can make bones weaker, which make fractures more likely. Vitamin D is
a natural substance from food and sunlight that can help keep bones strong. The
investigators will study how often participants have low levels of vitamin D while receiving
chemotherapy, and, for those with low levels, whether giving vitamin D supplements will
increase those levels.
Another focus of the study is to learn more about the biology of ALL and lymphoblastic
lymphoma by doing research on blood, bone and spinal fluid bone marrow samples. The goal of
this research is to improve treatment for children with leukemia in the future.
Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies [Recruiting]
This is an exploratory study to study the efficacy of combination regimen of
Oncaspar/Doxil/Decadron (ODD) in patients with refractory lymphoid malignancies. Patients
with any form of lymphoid malignancy will be eligible: acute lymphoblastic leukemia, chronic
lymphocytic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma and
plasma cell leukemia. Patients must have failed standard regimens for their cancers and
could have had unlimited number of prior regimens. Patients will be staged appropriately
for their disease with clinical examination, laboratory tests, and imaging studies. Both
Oncaspar and Doxil will be given on day 1 and 15. Patients will be clinically evaluated
prior to each cycle and will have disease assessments every 2 cycles. Responding patients
will continue therapy until disease progression or excessive toxicity. Responders who are
candidates for allogenic stem cell transplantation could go to conditioning chemotherapy and
stem cell transplant after 4 cycles of ODD.
A Study Evaluating IV Oncaspar® and IV Gemzar® in the Treatment of Solid Tumors and Lymphoma [Terminated]
This study will research the side effects of pegaspargase (pronounced "peg-as-par-gase"); its
brand name is ONCASPAR® when it is used with another FDA-approved cancer treatment
(chemotherapy) drug called gemcitabine HCl (pronounced "gem-site-a-bean"; its brand name is
Trial of Oncasparï¿½ and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia [Recruiting]
This is an assessment of efficacy and safety of three different doses of pegylated
recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults
with de novo acute lymphoblastic leukaemia (ALL). This study will provide first data for
determining specific asparaginase doses to yield various durations of L-asparagine (ASN)
depletion which are required within different treatment phases of ALL therapy.
Reports of Suspected Oncaspar (Pegaspargase) Side Effects
Infusion Related Reaction (6),
Death (5), more >>
Page last updated: 2011-12-09