Please select the eligibility criteria that correspond 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: DISEASE CHARACTERISTICS:

* Diagnosis of acute lymphoblastic leukemia (ALL)

  * No known mature B-cell ALL, defined by the presence of any of the following:

    * Surface immunoglobulin
    * L3 morphology
    * t(8;14)(q24;q32)
    * t(8;22)
    * t(2;8)
  * T-cell surface markers and t(8;14)(q24;q11) allowed
* No secondary ALL

PATIENT CHARACTERISTICS:

* No known HIV positivity
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* No prior therapy except steroids of ≤ 1 week in duration and/or emergent radiation therapy to the mediastinum

  * Patients treated with steroids within the past 7 days will not receive steroid prophase during study treatment
B: Inclusion Criteria:

* Confirmed diagnosis of ALL or lymphoblastic leukemia
* No prior therapy except short courses of corticosteroids, a single dose of IT cytarabine or emergent radiation to the mediastinum or other life-threatening masses

Exclusion Criteria:

* Have received more than 7 days of corticosteroids in the preceding 4 weeks or more than 28 days of corticosteroids in the preceding 6 months
* Have received any chemotherapy or radiotherapy for previous malignancy
* Receiving any other investigational agent
* Known to be HIV positive
* Uncontrolled intercurrent illness
* Pregnant or breastfeeding
* History of previous malignancy
C: Inclusion Criteria:

* Previously untreated T-lineage or precursor B-lineage ALL
* Patients must have morphological proof of ALL and diagnosis must be made from bone marrow morphology with more than 25% blasts
* Written informed consent
* Treatment according to DCOG ALL 10 protocol

Exclusion Criteria:

* Mature B-lineage ALL
* Patients with secondary ALL
* Known allergy to any ASNase preparation
* General health status according to Karnofsky / Lansky score \< 40%
* Pre-existing known coagulopathy (e.g. haemophilia)
* Pre-existing pancreatitis
* Liver insufficiency (Bilirubin \> 50 µmol/L; SGOT/SGPT \> 10 x ULN)
* Other current malignancies
* Pregnancy (planned or existent), breast feeding
D: Inclusion Criteria:

* Histologically confirmed acute lymphoblastic leukemia (ALL)
* No secondary ALL
* More than 4 weeks since prior chemotherapy
* More than 4 weeks since prior steroids

Exclusion Criteria:

* Prior disease that would preclude treatment with chemotherapy

Answer: A