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CalaspargasePegol (Asparlas) - acute lymphoblastic leukemia (ALL) View of CalaspargasePegol (Asparlas) | Canadian Journal of Health TechnologiesReturn to Article DetailsCalaspargase Pegol (Asparlas)
CalaspargasePegol (Asparlas) - Acute lymphoblastic leukemia View of CalaspargasePegol (Asparlas) | Canadian Journal of Health TechnologiesReturn to Article DetailsCalaspargase Pegol (Asparlas)
Calaspargasepegol-mknl (Asparlas) - To treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients Drug Approval Package: Asparlas * Skip to main page content * Skip to search * Skip to topics menu * Skip to common linksHHS U.S. Department of Health and Human Services U.S. Food and Drug Administration * Follow FDA * En EspañolSearch FDASubmit search * Popular Content * Home
Efficacy and Toxicity of Pegaspargase and CalaspargasePegol in Childhood Acute Lymphoblastic Leukemia: Results of DFCI 11-001. Dana-Farber Cancer Institute Acute Lymphoblastic Leukemia (ALL) Consortium Protocol 11-001 assessed efficacy and toxicity of calaspargasepegol (calaspargase), a novel pegylated asparaginase formulation with longer half-life, compared with the standard formulation
CalaspargasePegol An official website of the United States government Here's how you know Log inAccess keysNCBI HomepageMyNCBI HomepageMain ContentMain NavigationBookshelfSearch databaseBooksAll DatabasesAssemblyBiocollectionsBioProjectBioSampleBooksClinVarConserved DomainsdbGaPdbVarGeneGenomeGEO DataSetsGEO ProfilesGTRHomoloGeneIdentical Protein GroupsMedGenMeSHNLM Levels and EffectsSummary of Use during LactationNo information is available on the clinical use of calaspargasepegol during breastfeeding. Because calaspargase is a large protein molecule with a molecular weight of about 140,000 Da, the amount in milk is likely to be very low and it is probably partially destroyed in the infant's gastrointestinal tract and poorly absorbed by the infant. Polyethylene
FDA Approval Summary: CalaspargasePegol-mknl For Treatment of Acute Lymphoblastic Leukemia in Children and Young Adults. On December 20, 2018, the Food and Drug Administration approved calaspargasepegol-mknl (CALASP), an asparagine-specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month
A Phase 2 Study to Evaluate Efficacy of CalaspargasePegol-mknl and Decitabine Combined With Venetoclax in Pediatric, Adolescent, and Young Adult Patients With Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL) and T- Cell Lymphoblastic Lymp To learn if giving the study drugs calaspargasepegol-mknl and decitabine in combination with venetoclax can help to control relapsed/refractory T-ALL and T-LLy. The safety of this drug combination will also be studied. Primary Objectives: To characterize the clinical efficacy of Calaspargasepegol-mknl and Decitabine in combination with Venetoclax in pediatric, adolescent, and young adult patients with relapsed/refractory T-ALL/T-LLy based upon the complete response rate (CR). Secondary Objectives: To summarize efficacy per response rate
Pharmacokinetic and Pharmacodynamic Properties of CalaspargasePegol Escherichia coli L-Asparaginase in the Treatment of Patients With Acute Lymphoblastic Leukemia: Results From Children's Oncology Group Study AALL07P4. Asparaginase is a critical agent used to treat acute lymphoblastic leukemia (ALL). Pegaspargase (SS-PEG), a pegylated form of Escherichia coli L-asparaginase with a succinimidyl succinate (SS) linker, is the first-line asparaginase product used in Children's Oncology Group (COG) ALL trials. Calaspargasepegol (SC-PEG) replaces the SS linker in SS-PEG with a succinimidyl carbamate linker, creating a more stable molecule. COG AALL07P4 was designed to determine the pharmacokinetic and pharmacodynamic comparability of SC-PEG to SS-PEG in patients with newly diagnosed high-risk (HR) B
CalaspargasePegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer This phase I trial tests the safety, side effects, and best dose of calaspargasepegol-mknl in combination with cobimetinib in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic ). Cobimetinib attacks a protein called MEK that has been known to stimulate cells that promote the growth of cancer cells in the body. Calaspargasepegol-mknl is an enzyme that converts the amino acid L-asparagine into aspartic acid and ammonia. Many types of cancer cell rely on the amino acid L-asparagine, and depleting this amino acid with calaspargasepegol-mknl starves cancer cells of this nutrient
2157GCCC:Phase 1 of CalaspargasePegol-mknl w/ Cytarabine and Idarubicin in Newly Dx AML Characterizing the regimen limiting toxicity (RLT) of chemotherapeutic drug CalaspargasePegol-mknl as remission induction and consolidation chemotherapy in patients with newly diagnosed Acute Myeloid Leukemia (AML) and Identifying the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D ) of CalaspargasePegol-mknl. This is a multicenter, non-randomized, open-label, phase I study evaluating regimen-limiting toxicities of CalaspargasePegol-mknl administered intravenously in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia (AML).The trial will consist of the induction and consolidation phases of therapy. At the induction phase ( it usually lasts for 29 days): a high-dose of Cytarabine
CalaspargasePegol in Adults With ALL The purpose of this phase 2/3 study is to confirm the recommended doses and to evaluate the safety and pharmacodynamics of Calaspargasepegol for the treatment of adult patients with Philadelphia-negative Acute Lymphoblastic Leukemia. The study will be conducted in 2 parts. Part 1 is a dose confirmation run-in period. Part 2 will enroll the remaining
agents.Notesasparaginase erwinia chrysanthemi (crisantaspase) and asparaginase (calaspargasepegol)ReferencesBasch E (2010) The missing voice of patients in drug-safety reporting. N Engl J Med 362:865–869Article CAS PubMed PubMed Central Google Scholar Grunberg SM, Osoba D, Hesket h PJ, Gralla RJ, Borjeson S, Rapoport BL, du Bois A, Tonato M (2005) Evaluation of new antiemetic agents and definition of antineoplastic
properties of calaspargasepegol Escherichia coli L-asparaginase in the treatment of patients with acute lymphoblastic leukemia: results from Children's Oncology Group Study AALL07P4 . J Clin Oncol . 2014 ; 32 : 3874 - 3882 . 2 National Comprehensive Cancer Network . Acute Lymphocytic Leukemia (Version 2.2019) . 2019 . 3 De Stefano V , Za T , Ciminello A , Betti S , Rossi E . Haemostatic alterations
for adults with phenylketonuria.[Curr Med Res Opin. 2019]Review Pegademase Bovine.[Drugs and Lactation Database (...]Review Pegaspargase.[Drugs and Lactation Database (...]Review A Comprehensive Review of Pegvaliase, an Enzyme Substitution Therapy for the Treatment of Phenylketonuria.[Drug Target Insights. 2019]Review CalaspargasePegol.[Drugs and Lactation Database (...]See reviews...See all...Recent
Space for Calaspargase? A New Asparaginase for Acute Lymphoblastic Leukemia. In December 2018, the FDA approved calaspargasepegol-mknl (Asperlas, Servier Pharmaceuticals) for acute lymphoblastic leukemia (ALL) in children and young adults up to age 21. Asparaginase is a critical component in the treatment of ALL, but the niche for calaspargase within current treatment protocols is unclear..