Calaspargase Pegol or Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia; Adult B Acute Lymphoblastic Leukemia; Childhood B Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Calaspargase Pegol-mknl; Cyclophosphamide; Cytarabine; Daunorubicin Hydrochloride; Dexamethasone; Doxorubicin Hydrochloride; Laboratory Biomarker Analysis; Mercaptopurine; Methotrexate; Pegaspargase; Pharmacological Study; Prednisone; Radiation Therapy; Thioguanine; Vincristine Sulfate
Intervention description: Given IV; Given IV; Given IV, IT, PO, or SC; Given IV; Given PO or IV; Given IV; Correlative studies; Given PO; Given IV, IT, or PO; Given IV; Correlative studies; Given IV or PO; Some patients undergo RT; Given PO; Given IV
Intervention MeSH terms: Cytarabine; Dexamethasone; Dexamethasone acetate; Prednisone; Cortisone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Methotrexate; Vincristine; Daunorubicin; Asparaginase; Mercaptopurine; Pegaspargase; Thioguanine; BB 1101; 2-Aminopurine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 166.0
Sex: All
Minimum age: 2 Years
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      This randomized clinical trial is studying giving calaspargase pegol together with
      combination chemotherapy to see how well it works compared with giving pegaspargase together
      with combination chemotherapy in treating younger patients with newly diagnosed high-risk
      acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the
      growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving
      more than one drug (combination chemotherapy) may kill more cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be eligible for and enrolled on AALL08B1 or the successor classification
             study

          -  Patients must have newly diagnosed high-risk B lymphoblastic leukemia (World Health
             Organization [WHO] 2008 classification) (also termed B-precursor acute lymphoblastic
             leukemia)

          -  White blood cell (WBC) >= 50,000/μL for patients age 1-9 OR any WBC count for patients
             age 10-30 or for patients treated with prior steroids

          -  Patients shall have had no prior cytotoxic chemotherapy with the exception of steroids
             and intrathecal cytarabine; intrathecal chemotherapy with cytarabine is allowed prior
             to registration for patient convenience; this is usually done at the time of the
             diagnostic bone marrow or venous line placement to avoid a second lumbar puncture;
             (Note: the CNS status must be determined based on a sample obtained prior to
             administration of any systemic or intrathecal chemotherapy, except for steroid
             pretreatment) systemic chemotherapy must begin within 72 hours of this intrathecal
             therapy

          -  Patients receiving prior steroid therapy are eligible for this study; the dose and
             duration of previous steroid therapy should be carefully documented

          -  Pregnancy tests with a negative result must be obtained in all post-menarchal females

          -  Lactating females must agree that they will not breastfeed a child while on this study

        Exclusion Criteria:

          -  Patients with Down syndrome are excluded from this study

          -  Patients with testicular leukemia at diagnosis are excluded from this study

          -  Pregnant female patients are excluded from this study