Clinical trial NCT00089349 (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: methotrexate, mercaptopurine
SMILES: 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, S=C1N=CNC2=C1NC=N2
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of acute lymphoblastic leukemia (ALL)

               -  Meets 1 of the following criteria:

                    -  Second or subsequent bone marrow relapse

                    -  Failed ≥ 2 regimens for remission induction

                         -  Patients who relapse while receiving standard ALL maintenance
                            chemotherapy do not require a waiting period prior to study entry

          -  More than 25% blasts in bone marrow aspirate (M3 marrow)

               -  CD52 expression on ≥ 25% of malignant cells at relapse

          -  Philadelphia chromosome-positive patients must have failed prior imatinib mesylate

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

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

          -  At least 8 weeks

          -  ALT ≤ 5 times upper limit of normal (ULN)

          -  Bilirubin ≤ 1.5 times ULN

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

          -  Creatinine normal for age

          -  Pulse oximetry > 94%

          -  No evidence of dyspnea at rest

          -  No exercise intolerance

          -  No serious uncontrolled infection

          -  No autoimmune hemolytic anemia

          -  No autoimmune thrombocytopenia

          -  Not pregnant or nursing

               -  No nursing for 3 months after study participation

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 6 months after study
             participation

          -  Seizure disorder allowed provided patients are on anticonvulsants and symptoms are
             well controlled

          -  CNS toxicity ≤ grade 2

          -  No other serious uncontrolled medical condition (e.g., diabetes)

          -  Recovered from prior immunotherapy

          -  At least 8 weeks since prior biologic agents (e.g., monoclonal antibodies)

          -  More than 1 week since prior growth factor(s)

          -  At least 4 months since prior stem cell transplantation

               -  No evidence of active acute or chronic graft-versus-host disease post allogeneic
                  stem cell transplantation

          -  No prior alemtuzumab or its components

          -  No other concurrent anticancer immunomodulating agents

          -  Recovered from prior chemotherapy

          -  One dose of prior intrathecal (IT) methotrexate, cytarabine, and hydrocortisone; IT
             cytarabine alone; or IT methotrexate alone allowed as part of initial diagnostic
             spinal tap

          -  Prior hydroxyurea therapy allowed

          -  No other concurrent anticancer chemotherapy agents

          -  Prior steroid therapy allowed

          -  More than 2 weeks since prior radiotherapy and recovered