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)
A Pilot Study of Oncaspar´┐Ż + Dexamethasone in Patients With Relapsed or Refractory T-Cell Lymphoma [Terminated]
This is an open-label, single-arm pilot study of Oncaspar« with dexamethasone for patients
with relapsed or refractory peripheral T-cell lymphoma (PTCL), excluding extranodal NK/T
cell lymphoma (ENKTL). Patients will receive up to 8 courses of treatment.
Oncaspar/Doxil/Decadron in Patients With Refractory Lymphoid Malignancies [Completed]
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.
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
Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia [Active, not recruiting]
This randomized clinical trial is studying giving calaspargase pegol together with
combination chemotherapy to see how well it works compared with giving pegaspargase together
with combination chemotherapy in treating younger patients with newly diagnosed high-risk
acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the
growth of cancer cells, either by killing the cells or by stopping them from dividing.
Giving more than one drug (combination chemotherapy) may kill more cancer cells.
Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011) [Active, not recruiting]
This pilot clinical trial studies the side effects of pegaspargase when given together with
combination chemotherapy in treating patients with newly diagnosed high-risk acute
lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of
the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to
stop the growth of cancer cells, either by killing the cells, by stopping them from
dividing, or by stopping them from spreading. Giving more than one drug (combination
chemotherapy) together with pegaspargase may kill more cancer cells.
Reports of Suspected Oncaspar (Pegaspargase) Side Effects
Infusion Related Reaction (6),
Death (5), more >>
Page last updated: 2011-12-09