#1 prescribed asparaginase treatment for acute lymphoblastic leukemia (ALL) regimens1,2
ABOUT ASPARLAS
#1 prescribed asparaginase treatment for acute lymphoblastic leukemia (ALL) regimens1,2
ABOUT ASPARLAS
aAs of November 2024.
8386 patients aged 1 to 30 years with newly diagnosed B-ALL treated with PEGylated asparaginase as part of an ALL treatment regimen
An analysis of data collected from the COG AALL0331 and COG AALL0232 studies current to the year 2018 for patients that discontinued PEGylated asparaginase for any reason
Determine the effect of receiving all doses of PEGylated asparaginase on DFS
377 children aged 0 to 18 years with newly diagnosed ALL; median age at diagnosis was 4.4 years
Prospective, randomized trial comparing 20 vs 30 weeks of asparaginase intensification treated with DFCI 91-01 Consortium Protocol. Patients were eligible to participate in 5 randomizations, investigational window for different courses of corticosteroids, PEGylated asparaginase or native asparaginase, high-dose or conventional 6-mercaptopurine (6-MP), bolus or infused doxorubicin, and either twice-daily hyperfractioned or once-daily conventional cranial radiation
Efficacy of 20 vs 30 weeks of asparaginase therapy on outcomes of patients treated with DFCI Protocol 91-01
177 patients with hematologic malignancies treated with at least one IV dose of pegaspargase; mean age at diagnosis was 9.1 years.
A retrospective chart review for all patients that received at least one IV dose of pegaspargase between November 2011 and April 2018 in relation to the implementation of the universal premedication policy on February 16, 2016.
Primary end point: The difference in rate of substitution of pegaspargase for Erwinia chrysanthemi pre- and post-policy implementation.
Secondary end point: The difference in rate of acute adverse events during infusion pre- and post-policy implementation, differences in serum asparaginase activity levels between products and pre- and post-policy implementation, and cost-benefit analysis of premedication.
239 children and adolescents with newly diagnosed B-cell or T-cell ALL; median age of enrollment was 5 years (range, 1 to <21 years).
Open-label, randomized, active-controlled, multicenter clinical trial in which patients were randomly assigned ASPARLAS 2500 U/m2 (n=119) or pegaspargase 2500 IU/m2 (n=120) as part of a Dana-Farber Cancer Institute (DFCI) ALL Consortium backbone therapy. The median number of doses during the study was 11 doses for ASPARLAS (administered every 3 weeks) and 16 doses for pegaspargase (administered every 2 weeks). The median duration of exposure was 8 months for both ASPARLAS and pegaspargase.
Primary end point: Assessment of the safety and feasibility associated with the administration of ASPARLAS 2500 U/m2 given intravenously as a single dose during remission induction and then every 3 weeks for 30 weeks during postinduction therapy in children and adolescents with newly diagnosed ALL.
165 patients aged 1 to <31 years with newly diagnosed high-risk B-cell ALL; median age was 11 years.
Open-label, randomized, active-controlled, multicenter trial in which patients were randomly assigned at a 2:1 ratio to receive ASPARLAS 2100 U/m2 (n=69), ASPARLAS 2500 U/m2 (n=42), or pegaspargase 2500 IU/m2 (n=54) as part of an otherwise identical Children's Oncology Group (COG) augmented Berlin-Frankfurt-Münster therapy regimen.
Primary end point: Assessment of the pharmacokinetic and pharmacodynamic comparability of ASPARLAS and pegaspargase when administered intravenously during induction and consolidation therapy in newly diagnosed patients with high-risk B-cell ALL.
Secondary end point: Safety, serum and cerebrospinal fluid asparagine levels, immunogenicity, end-induction minimal residual disease, percentage of patients who were rapid early responders, and complete remission and event-free survival rates.
ASPARLAS IMPORTANT SAFETY INFORMATION
Hypersensitivity: Grade 3 and 4 hypersensitivity reactions including anaphylaxis have been reported in clinical trials with ASPARLAS with an incidence of 7% to 21%. Because of the risk of serious allergic reactions, administer ASPARLAS in a clinical setting with resuscitation equipment and other agents necessary to treat anaphylaxis. Premedicate patients 30-60 minutes prior to administration of ASPARLAS. Observe patients for 1 hour after administration. Discontinue ASPARLAS in patients with serious hypersensitivity reactions.
Pancreatitis: Cases of pancreatitis have been reported in clinical trials with ASPARLAS with an incidence of 12% to 16%. Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Assess serum amylase and/or lipase levels to identify early signs of pancreatic inflammation. Discontinue ASPARLAS in case of suspicion of pancreatitis. If pancreatitis is confirmed, do not resume ASPARLAS.
Thrombosis: Serious thrombotic events, including sagittal sinus thrombosis, have been reported in clinical trials with ASPARLAS with an incidence of 9% to 12%. Discontinue ASPARLAS in patients experiencing serious thrombotic events.
Hemorrhage: Hemorrhage associated with increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenemia have been reported. Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, and fibrinogen. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy.
Hepatotoxicity: Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of hepatic veno-occlusive disease (VOD), have been observed in patients treated with ASPARLAS in combination with standard chemotherapy, including during the induction phase of multiphase chemotherapy. Do not administer ASPARLAS to patients with severe hepatic impairment. Evaluate bilirubin and transaminases prior to each dose of ASPARLAS and at least weekly, during cycles of treatment that include ASPARLAS, through 6 weeks after the last dose of ASPARLAS. Monitor frequently for signs and symptoms of hepatic VOD, which may include rapid weight gain, fluid retention with ascites, hepatomegaly (which may be painful), and rapid increase of bilirubin. For patients who develop abnormal liver tests after ASPARLAS, more frequent monitoring for liver test abnormalities and clinical signs and symptoms of VOD is recommended. In the event of serious liver toxicity, including VOD, discontinue treatment with ASPARLAS and provide supportive care.
The most common grade 3 and above adverse reactions (incidence ≥10%) for patients receiving ASPARLAS with multiagent chemotherapy observed in the DFCI clinical trial were elevated transaminase (52%), increased bilirubin (20%), pancreatitis (18%) and abnormal clotting studies (14%). There was 1 fatal adverse reaction (multi-organ failure in the setting of chronic pancreatitis associated with a pancreatic pseudocyst). Not all grade 1 and 2 adverse reactions were collected prospectively.
ASPARLAS® (calaspargase pegol-mknl) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years.
Please see ASPARLAS Full Prescribing Information.
ASPARLAS IMPORTANT SAFETY INFORMATION
Hypersensitivity: Grade 3 and 4 hypersensitivity reactions including anaphylaxis have been reported in clinical trials with ASPARLAS with an incidence of 7% to 21%. Because of the risk of serious allergic reactions, administer ASPARLAS in a clinical setting with resuscitation equipment and other agents necessary to treat anaphylaxis. Premedicate patients 30-60 minutes prior to administration of ASPARLAS. Observe patients for 1 hour after administration. Discontinue ASPARLAS in patients with serious hypersensitivity reactions.
Pancreatitis: Cases of pancreatitis have been reported in clinical trials with ASPARLAS with an incidence of 12% to 16%. Inform patients of the signs and symptoms of pancreatitis, which, if left untreated, could be fatal. Assess serum amylase and/or lipase levels to identify early signs of pancreatic inflammation. Discontinue ASPARLAS in case of suspicion of pancreatitis. If pancreatitis is confirmed, do not resume ASPARLAS.
Thrombosis: Serious thrombotic events, including sagittal sinus thrombosis, have been reported in clinical trials with ASPARLAS with an incidence of 9% to 12%. Discontinue ASPARLAS in patients experiencing serious thrombotic events.
Hemorrhage: Hemorrhage associated with increased prothrombin time (PT), increased partial thromboplastin time (PTT), and hypofibrinogenemia have been reported. Evaluate patients with signs and symptoms of hemorrhage with coagulation parameters including PT, PTT, and fibrinogen. Consider appropriate replacement therapy in patients with severe or symptomatic coagulopathy.
Hepatotoxicity: Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of hepatic veno-occlusive disease (VOD), have been observed in patients treated with ASPARLAS in combination with standard chemotherapy, including during the induction phase of multiphase chemotherapy. Do not administer ASPARLAS to patients with severe hepatic impairment. Evaluate bilirubin and transaminases prior to each dose of ASPARLAS and at least weekly, during cycles of treatment that include ASPARLAS, through 6 weeks after the last dose of ASPARLAS. Monitor frequently for signs and symptoms of hepatic VOD, which may include rapid weight gain, fluid retention with ascites, hepatomegaly (which may be painful), and rapid increase of bilirubin. For patients who develop abnormal liver tests after ASPARLAS, more frequent monitoring for liver test abnormalities and clinical signs and symptoms of VOD is recommended. In the event of serious liver toxicity, including VOD, discontinue treatment with ASPARLAS and provide supportive care.
The most common grade 3 and above adverse reactions (incidence ≥10%) for patients receiving ASPARLAS with multiagent chemotherapy observed in the DFCI clinical trial were elevated transaminase (52%), increased bilirubin (20%), pancreatitis (18%) and abnormal clotting studies (14%). There was 1 fatal adverse reaction (multi-organ failure in the setting of chronic pancreatitis associated with a pancreatic pseudocyst). Not all grade 1 and 2 adverse reactions were collected prospectively.
ASPARLAS® (calaspargase pegol-mknl) is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years.
Please see ASPARLAS Full Prescribing Information.
