Clinical trial NCT00103285 (phase 3, status: unknown status)
Conditions: b-cell childhood acute lymphoblastic leukemia, untreated childhood acute lymphoblastic leukemia
ICD codes: C83.57, C83.50, C91.01, C91.02, C83.52, C83.56, C83.53
Drugs: doxorubicin hydrochloride, cytarabine, dexamethasone, pegaspargase, methotrexate, leucovorin calcium, mercaptopurine, cyclophosphamide, thioguanine, vincristine sulfate
SMILES: COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, ClCCN(CCCl)P1(=O)NCCCO1, C[C@@H](O[C@H]1OCCN(CC2=NNC(=O)N2)[C@H]1C1=CC=C(F)C=C1)C1=CC(=CC(=C1)C(F)(F)F)C(F)(F)F, N[C@@H](CC1=CN=CN1)C(O)=O, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O, NC1=NC(=O)C2=C(NC[C@H](CNC3=CC=C(C=C3)C(=O)N[C@@H](CCC(O)=O)C(O)=O)N2C=O)N1, S=C1N=CNC2=C1NC=N2, ClCCN(CCCl)P1(=O)NCCCO1, NC1=NC(=S)C2=C(N1)N=CN2, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be enrolled on AALL03B1 prior to enrollment on AALL0331

          -  Initial white blood cells (WBC) < 50,000/ul

          -  Newly diagnosed B-precursor acute lymphoblastic leukemia

               -  Standard-risk (SR) disease meeting 1 of the following criteria:

               -  SR-average by age and WBC

               -  No unfavorable features

               -  Rapid early responder (RER) by day 15

               -  CNS 1 or 2

               -  Minimal residual disease (MRD) negative on day 29

               -  Trisomies of 4, 10, and 17 or TEL-AML1 translocation and RER and CNS2 allowed

               -  SR-low by age and WBC

               -  No unfavorable features

               -  RER by day 15

               -  MRD negative on day 29

               -  CNS1

               -  Favorable cytogenetics-trisomies of 4, 10, and 17 or TEL-AML translocation

               -  SR-high

               -  Unfavorable features meeting ≥ 1 of the following criteria:

                    -  MLL rearrangements and RER

                    -  Steroid pretreatment

                    -  CNS3

                    -  Slow early responder by morphology or MRD

          -  Patients with Down syndrome are allowed

          -  Patients with overt testicular disease are not eligible for this study, but may be
             eligible for AALL0232

          -  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 central nervous system [CNS] status must be determined based on a sample
             obtained prior to administration of any systemic or intrathecal chemotherapy, except
             for steroid pretreatment

          -  Patients receiving prior steroid therapy may be eligible for AALL0331 study

          -  Patients with a contraindication to additional asparaginase therapy, following
             Induction, are not eligible for the Standard Risk-Low study, and should be removed
             from protocol therapy at the end of Induction

          -  Patients who are assigned to the standard risk-average group following Induction and
             who meet the HRQOL

          -  Age at diagnosis >= 2 years (note that this is a more restrictive age range than for
             the therapeutic component of the study)

          -  At least one parent with reading comprehension of English or Spanish languages for
             which validated surveys exist

          -  Diagnosis at one of the institutions participating in this limited institution
             correlative study

          -  A parent or legal guardian must sign a written informed consent/parental permission
             for all patients

          -  All institutional, Food and Drug Administration (FDA), and National Cancer Institute
             (NCI) requirements for human studies must be met