Intravenous pegylated asparaginase versus intramuscular native Escherichia coli l-asparaginase in newly diagnosed childhood acute lymphoblastic leukaemia (DFCI 05-001): a randomised, open-label phase 3 trial

Is Erwinase Necessary for all Children With ALL and Allergic Reactions to E. coli Asparaginase?

“…11,12 In the recent randomized study of DFCI 05-001, treatment with intravenous peg-asparaginase led to significantly higher nadir serum asparaginase levels than did intramuscular native E coli asparaginase but did not further improve outcome. 13 These findings indicate that high-dose or extended treatment with asparaginase is not necessary for some patients with ALL, especially those with standard-risk ALL, supporting the conclusion of Liang and associates.…”

Central Nervous System Complications in Children Receiving Chemotherapy or Hematopoietic Stem Cell Transplantation

“…So far, although recent paper highlighted a lower thrombin generation profile with pegylated Escherichia coli asparaginase (PEG-ASP) than with native ASP, no difference has been demonstrated in influencing thrombotic complications in clinical trials between the different ASP formulations, as native Escherichia coli -ASP and PEG-ASP. Few data are available about adverse effects of Erwinia ASP, but no significant differences with E. Coli ASP profile were found (119–121). Concomitant use of corticosteroids and ASP has been investigated as a worsening factor for thrombotic events but no agreement was achieved (122).…”

Refining risk classification in childhood B acute lymphoblastic leukemia: results of DFCI ALL Consortium Protocol 05-001

“…Consolidation IB included cyclophosphamide (1000 mg/m 2 on day 1), low-dose cytarabine (75 mg/m 2 per day, days 2-5 and 9-12), 6-mercaptopurine (50 mg/m 2 per day, days [1][2][3][4][5][6][7][8][9][10][11][12][13][14], and intrathecal methotrexate (day 1). Consolidation IC included cytarabine (2 g/m 2 per dose IV every 12 hours for 4 doses starting day 1), etoposide (100 mg/m 2 per day, days 3-5), dexamethasone (18 mg/m 2 per day, days 1-5), and L-asparaginase beginning day 8.…”

“…11 Patients who declined randomization were directly assigned to IM E coli asparaginase. After February 2010, when the randomization had met target accrual, patients were directly assigned to IM E coli asparaginase.…”

“…After February 2010, when the randomization had met target accrual, patients were directly assigned to IM E coli asparaginase. Because there was no difference in outcome between native E coli L-asparaginase and pegaspargase during the randomized portion of the trial, 11 ). IKZF1 deletion status was included in modeling where indicated.…”