Clinical trial NCT00098839 (phase 1/phase 2, status: completed)
Conditions: recurrent childhood acute lymphoblastic leukemia
ICD codes: C83.57, C83.50, C91.01, C91.02, C83.52, C83.56, C83.53
Drugs: l-asparaginase, doxorubicin hydrochloride, therapeutic hydrocortisone, vincristine sulfate, cytarabine, prednisone, pegaspargase, dexrazoxane hydrochloride, methotrexate, etoposide, cyclophosphamide, leucovorin calcium
SMILES: N[C@@H](CC(O)=O)C(O)=O, 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, [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, 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, ClCCN(CCCl)P1(=O)NCCCO1, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C, N[C@@H](CC1=CN=CN1)C(O)=O, C[C@@H](CN1CC(=O)NC(=O)C1)N1CC(=O)NC(=O)C1, 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, OCCOCCN1CCN(CC1)C(C1=CC=CC=C1)C1=CC=C(Cl)C=C1, ClCCN(CCCl)P1(=O)NCCCO1, 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
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of B lymphoblastic leukemia (B-ALL)

               -  At least 25% expression of CD22 by immunophenotyping

               -  In marrow relapse (M3 bone marrow) with or without associated extramedullary
                  disease as defined by 1 of the following:

                    -  In first or later marrow relapse occurring any time after initial diagnosis
                       (part A [closed to accrual as of 10/30/06] or B)

                    -  In first, early marrow relapse with or without associated extramedullary
                       disease occurring < 36 months from the time of initial diagnosis (part B
                       only)

          -  No B-cell L3 morphology OR evidence of a regulator gene that codes for a transcription
             factor (MYC) translocation by molecular or cytogenetic analysis

          -  No Down syndrome

          -  Patients with CNS or other extramedullary site involvement are allowed

          -  Performance status - Karnofsky 50-100% (for patients > 10 years of age)

          -  Performance status - Lansky 50-100% (for patients ≤ 10 years of age)

          -  White Blood Count (WBC) ≤ 50,000/mm^3 (part A only [closed to accrual as of 10/30/06])

          -  Bilirubin ≤ 1.5 times upper limit of normal unless disease-related (ULN)

          -  Alanine aminotransferase (ALT) ≤ 5 times ULN

          -  Albumin ≥ 2 g/dL

          -  Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min

          -  Creatinine as defined by age as follows:

               -  ≤ 0.5 mg/dL (for patients < 1 year old)

               -  ≤ 0.8 mg/dL (for patients 1 to 5 years old)

               -  ≤ 1.0 mg/dL (for patients 6 to 10 years old)

               -  ≤ 1.2 mg/dL (for patients 11 to 15 years old)

               -  ≤ 1.5 mg/dL (for patients > 15 years old)

          -  Shortening fraction ≥ 27% by echocardiogram

          -  Ejection fraction ≥ 45% by Multi Gated Acquisition Scan (MUGA)

          -  No dyspnea at rest

          -  No exercise intolerance

          -  Pulse oximetry > 94%

          -  No active or uncontrolled infection

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Recovered from prior immunotherapy

          -  At least 4 months since prior stem cell transplantation or rescue AND no evidence of
             active graft-vs-host disease

          -  At least 7 days since prior hematopoietic growth factors

          -  At least 7 days since prior biologic therapy*

          -  No other concurrent immunotherapy

          -  No other concurrent biologic therapy

          -  Recovered from prior chemotherapy

               -  No waiting period for children who relapse while receiving standard ALL
                  maintenance therapy

          -  No prior cumulative anthracycline exposure > 400 mg/m^2*

          -  No concurrent chemotherapy

          -  Recovered from prior radiotherapy

          -  No concurrent radiotherapy

          -  At least 2 days since prior hydroxyurea

          -  No other concurrent investigational drugs

          -  No other concurrent anticancer agents