A Phase II Study of Campath-1H in Children With Acute Lymphoblastic Leukemia in Second or Greater Relapse or Twice Induction Failure

Fecha de inicio: 1 de julio de 2004

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