Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Treatment of Acute Lymphoblastic Leukemia in Children
Brief Summary: RATIONALE: L-asparaginase is an important component of treatment for childhood acute lymphoblastic leukemia, but is also associated with notable side-effects, including hypersensitivity, pancreatitis, and thrombosis. We have previously reported that patients with acute lymphoblastic leukemia in whom asparaginase treatment was discontinued because of intolerable side-effects had survival outcomes that were inferior to those who received all or nearly all of their intended doses. Two bacterial sources of asparaginase exist: Escherichia coli (E coli) and Erwinia chrysanthemia (Erwinia). Generally, the E coli-derived enzyme has been used as front-line therapy and the Erwinia-derived preparation has been reserved for patients who develop hypersensitivity reactions. Pegylated E coli asparaginase (PEG-asparaginase) has a longer half-life and is potentially less immunogenic than native E coli L-asparaginase, and has been used as the initial asparaginase preparation in some pediatric acute lymphoblastic leukemia treatment regimens.

PURPOSE: Although the pharmacokinetics of each of these asparaginase preparations: intravenous PEG-asparaginase (IV-PEG) and intramuscular native E coli L-asparaginase (IM-EC) have been well characterized, their relative efficacy and toxicity have not been studied extensively.


Options:
A: Arm Label: Intramuscular native E coli L-asparaginase (IM-EC); Type: ACTIVE_COMPARATOR; Interventions: Drug: asparaginase, Drug: cyclophosphamide, Drug: cytarabine, Drug: dexamethasone, Drug: dexrazoxane hydrochloride, Drug: doxorubicin hydrochloride, Drug: etoposide, Drug: leucovorin calcium, Drug: mercaptopurine, Drug: methotrexate, Drug: methylprednisolone, Drug: prednisolone, Drug: therapeutic hydrocortisone, Drug: vincristine sulfate, Radiation: radiation therapy | Arm Label: Intravenous PEG-asparaginase (IV-PEG); Type: EXPERIMENTAL; Interventions: Drug: cyclophosphamide, Drug: cytarabine, Drug: dexamethasone, Drug: dexrazoxane hydrochloride, Drug: doxorubicin hydrochloride, Drug: etoposide, Drug: leucovorin calcium, Drug: mercaptopurine, Drug: methotrexate, Drug: methylprednisolone, Drug: pegaspargase, Drug: prednisolone, Drug: therapeutic hydrocortisone, Drug: vincristine sulfate, Radiation: radiation therapy | Intervention Type: DRUG; Name: asparaginase; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC) | Intervention Type: DRUG; Name: cyclophosphamide; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: cytarabine; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: dexamethasone; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: dexrazoxane hydrochloride; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: doxorubicin hydrochloride; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: etoposide; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: leucovorin calcium; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: mercaptopurine; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: methotrexate; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: methylprednisolone; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: pegaspargase; Assigned to Arm(s): Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: prednisolone; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: therapeutic hydrocortisone; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: vincristine sulfate; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: RADIATION; Name: radiation therapy; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG)
B: Arm Label: SC-PEG (Arm A); Type: ACTIVE_COMPARATOR; Interventions: Drug: SC-PEG | Arm Label: Oncaspar (Arm B); Type: ACTIVE_COMPARATOR; Interventions: Drug: Oncaspar | Intervention Type: DRUG; Name: SC-PEG; Assigned to Arm(s): SC-PEG (Arm A) | Intervention Type: DRUG; Name: Oncaspar; Assigned to Arm(s): Oncaspar (Arm B)
C: Arm Label: asparaginase medac; Type: ACTIVE_COMPARATOR; Interventions: Drug: asparaginase | Arm Label: recombinant asparaginase; Type: EXPERIMENTAL; Interventions: Drug: recombinant asparaginase | Intervention Type: DRUG; Name: asparaginase; Assigned to Arm(s): asparaginase medac | Intervention Type: DRUG; Name: recombinant asparaginase; Assigned to Arm(s): recombinant asparaginase
D: Arm Label: I; Type: EXPERIMENTAL; Interventions: Drug: asparaginase, Drug: cyclophosphamide, Drug: cytarabine, Drug: daunorubicin, Drug: mercaptopurine, Drug: Methotrexate, Drug: prednisone, Drug: Vincristine | Arm Label: II; Type: EXPERIMENTAL; Interventions: Drug: dexamethasone, Drug: asparaginase, Drug: cyclophosphamide, Drug: cytarabine, Drug: daunorubicin, Drug: mercaptopurine, Drug: Methotrexate, Drug: Vincristine | Arm Label: Reintensification Arm I; Type: EXPERIMENTAL; Interventions: Drug: Asparaginase, Drug: cyclophosphamide, Drug: cytarabine, Drug: doxorubicin, Drug: mercaptopurine, Drug: Methotrexate, Drug: thioguanine, Drug: Vincristine | Arm Label: Reintensification Arm II; Type: EXPERIMENTAL; Interventions: Drug: Asparaginase, Drug: cyclophosphamide, Drug: cytarabine, Drug: doxorubicin, Drug: mercaptopurine, Drug: Methotrexate, Drug: thioguanine, Drug: Vincristine | Arm Label: Reintensification Arm III; Type: EXPERIMENTAL; Interventions: Drug: Asparaginase, Drug: cytarabine, Drug: doxorubicin, Drug: mercaptopurine, Drug: Methotrexate, Drug: Vincristine | Arm Label: Reintensification Arm IV; Type: EXPERIMENTAL; Interventions: Drug: Etoposide, Drug: Ifosfamide, Drug: Methotrexate, Drug: Vincristine, Drug: Vindesine | Arm Label: Reintensification Arm V; Type: EXPERIMENTAL; Interventions: Drug: Etoposide, Drug: Ifosfamide, Drug: Methotrexate, Drug: Vincristine, Drug: Vindesine | Intervention Type: DRUG; Name: dexamethasone; Assigned to Arm(s): II | Intervention Type: DRUG; Name: asparaginase; Assigned to Arm(s): I, II | Intervention Type: DRUG; Name: Asparaginase; Assigned to Arm(s): Reintensification Arm I, Reintensification Arm II, Reintensification Arm III | Intervention Type: DRUG; Name: cyclophosphamide; Assigned to Arm(s): I, II, Reintensification Arm I, Reintensification Arm II | Intervention Type: DRUG; Name: cytarabine; Assigned to Arm(s): I, II, Reintensification Arm I, Reintensification Arm II, Reintensification Arm III | Intervention Type: DRUG; Name: daunorubicin; Assigned to Arm(s): I, II | Intervention Type: DRUG; Name: doxorubicin; Assigned to Arm(s): Reintensification Arm I, Reintensification Arm II, Reintensification Arm III | Intervention Type: DRUG; Name: Etoposide; Assigned to Arm(s): Reintensification Arm IV, Reintensification Arm V | Intervention Type: DRUG; Name: Ifosfamide; Assigned to Arm(s): Reintensification Arm IV, Reintensification Arm V | Intervention Type: DRUG; Name: mercaptopurine; Assigned to Arm(s): I, II, Reintensification Arm I, Reintensification Arm II, Reintensification Arm III | Intervention Type: DRUG; Name: Methotrexate; Assigned to Arm(s): I, II, Reintensification Arm I, Reintensification Arm II, Reintensification Arm III, Reintensification Arm IV, Reintensification Arm V | Intervention Type: DRUG; Name: prednisone; Assigned to Arm(s): I | Intervention Type: DRUG; Name: thioguanine; Assigned to Arm(s): Reintensification Arm I, Reintensification Arm II | Intervention Type: DRUG; Name: Vincristine; Assigned to Arm(s): I, II, Reintensification Arm I, Reintensification Arm II, Reintensification Arm III, Reintensification Arm IV, Reintensification Arm V | Intervention Type: DRUG; Name: Vindesine; Assigned to Arm(s): Reintensification Arm IV, Reintensification Arm V

Answer: A