Clinical trial NCT00003728 (phase 3, status: unknown status)
Conditions: leukemia, lymphoma
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: asparaginase, cyclophosphamide, cytarabine, daunorubicin hydrochloride, dexamethasone, doxorubicin hydrochloride, etoposide, leucovorin calcium, mercaptopurine, methotrexate, methylprednisolone, mitoxantrone hydrochloride, prednisolone, therapeutic hydrocortisone, thioguanine, vincristine sulfate, vindesine
SMILES: N[C@@H](CC(O)=O)C(O)=O, ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1, 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(C)=O)C(O)=C1C2=O, 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, 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, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, 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, 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, [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C, OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O, [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, [H][C@@]12CC[C@](O)(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C, 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, [H][C@@]12N3CC[C@@]11C4=C(C=C(OC)C(=C4)[C@]4(C[C@@H]5C[N@@](C[C@](O)(CC)C5)CCC5=C4NC4=CC=CC=C54)C(=O)OC)N(C)[C@@]1([H])[C@](O)([C@H](O)[C@]2(CC)C=CC3)C(N)=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed acute lymphoblastic leukemia (ALL) of FAB L1 or L2 morphology

               -  Positive SIg allowed OR

          -  Histologically confirmed precursor B or precursor T lymphoblastic non-Hodgkin's
             lymphoma (NHL)

               -  No diffuse large cell B-cell lymphoma, Burkitt's lymphoma, or high-grade B-cell
                  lymphoma (Burkitt-like)

          -  Very low-risk (VLR) patients meeting 1 of the following criteria:

               -  ALL of B-cell lineage

                    -  WBC less than 10,000/mm^3

                    -  Must meet 1 of the following conditions:

                         -  DNA index greater than 1.16 and less than 1.50 and chromosome number
                            51-66 or unknown

                         -  DNA index not assessed and chromosome number 51-66

                         -  DNA index greater than 1.16 and less than 1.50 and chromosome number is
                            unknown

                    -  Good response to prephase therapy

                    -  Absence of t(9;22) or BCR/ABL, t(4;11)/MLL-AF4, or 11q23/MLL rearrangement

                    -  No acute undifferentiated leukemia (AUL)

                    -  No CNS or gonadal involvement

               -  Precursor B-lymphoblastic NHL stage I or II OR

          -  Average risk (AR) patients:

               -  Must meet 1 of the following criteria:

                    -  ALL with good response to prephase therapy who are neither VLR or very high
                       risk (VHR)

                    -  VLR ALL with CNS involvement (CSF positive or negative)

                    -  Precursor B-lymphoblastic NHL stage III or IV without any VHR feature

                    -  Precursor T-lymphoblastic NHL

               -  AR patients substratified in:

                    -  AR1: B-cell lineage ALL with WBC less than 100,000/mm^3

                         -  Surreptitious or hemorrhagic CSF becoming negative at D4 of prephase
                            therapy

                         -  Precursor B-lymphoblastic NHL stage III or IV

                         -  Precursor T-lymphoblastic NHL stage I or II

                    -  AR2: B-cell lineage ALL with WBC at least 100,000/mm^3

                         -  T-cell lineage ALL regardless of the WBC

                         -  Overt or non-equivocal CNS involvement at D0 or any CSF involvement at
                            D4

                         -  Gonadal involvement

                         -  Precursor T-lymphoblastic NHL stage III or IV

               -  Newborn Down syndrome patients with AR2 features are assigned to the AR1 group OR

          -  VHR patients:

               -  Must meet 1 of the following criteria:

                    -  ALL patients meeting 1 of the following conditions:

                         -  Poor response to prephase therapy (at least 1,000/mm^3 blasts in
                            peripheral blood after completion of prephase therapy)

                         -  t(9;22) or BCR/ABL

                         -  t(4;11)/MLL-AF4 = 11q23/MLL rearrangement

                         -  Near haploidy (no more than 34 chromosomes or DNA index less than 0.7)

                         -  Hypodiploid (35-40 chromosomes or DNA index 0.7 to 0.8)

                         -  AUL

                         -  For B lineage ALL: failure to achieve complete response (CR) after
                            completion of protocol IA

                         -  For T lineage ALL: failure to achieve CR or good partial response (GPR)
                            after completion of protocol IA

                         -  Minimal-residual disease (greater than 1,000 blasts/100,000 mononuclear
                            bone marrow cells) at evaluation of IA (day 35)

                    -  NHL patients who failed to achieve CR or GPR after completion of protocol IA

               -  All VHR patients are eligible for stem cell transplantation except those whose
                  sole VHR criterion is a poor response to prephase therapy and who have none of
                  the following features:

                    -  T-cell immunophenotype

                    -  Early B ALL (CD10 negative)

                    -  WBC at least 100,000/mm^3

               -  Newborn Down syndrome patients with VHR features are assigned to AR1 group NOTE:
                  A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by
                  PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the
                  former terminology of "low", "intermediate", or "high" grade lymphoma. However,
                  this protocol uses the former terminology.

        PATIENT CHARACTERISTICS:

        Age:

          -  Under 18

        Performance status:

          -  Not specified

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  See Disease Characteristics

        Hepatic:

          -  Not specified

        Renal:

          -  Not specified

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  See Disease Characteristics

        Chemotherapy:

          -  Not specified

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  Not specified

        Surgery:

          -  Not specified

        Other:

          -  No prior therapy