a safety confirmatory study of alemtuzumab in japanese patients with relapsed or refractory chronic lymphocytic leukemia

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Summary: the primary objective of this study is to confirm the safety profile of alemtuzumab 30 mg (the us/european union (eu) approved dose) in japanese patients with relapsed or refractory chronic lymphocytic leukemia (cll).

note: this study was previously posted by bayer. in december 2009, this study was acquired by genzyme corporation. genzyme japan k.k. is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * b-cell chronic lymphocytic leukemia (b-cll) according to the 1996 national cancer institute-sponsored working group (nci-wg) criteria * one or more, but \<= 3 previous treatment regimens for chronic lymphocytic leukemia (cll) * patient requires treatment for cll (rai stage iii and iv disease or stage 0 to ii disease with evidence of progression) * adequate bone marrow, liver and renal function * more than 4 weeks since prior chemotherapy or chemoimmunotherapy, including investigational agents, for the treatment of cll. patient must have recovered from the acute side effects incurred as a result of previous therapy * world health organization (who) performance status (ps) 0,1 * life expectancy of at least 24 weeks * women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to the start of treatment. both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 2 weeks after the completion of trial * written informed consent exclusion criteria: * known human immunodeficiency virus (hiv) seropositivity * active hepatitis or a history of prior viral hepatitis b or hepatitis c, or positive hepatitis b serologies. patients with a positive hepatitis b surface antibody (hbsab) test with a documented history of prior hepatitis b immunization are eligible as long as other criteria are met (i.e., negative tests for : hepatitis b surface antigen \[hbsag\], hepatitis b core antibody \[hbcab\] and hepatitis c virus antibody \[hcvab\]) * active uncontrolled infection * recent documented history (within 2 years) of active tuberculosis (tb), current active tb infection, currently receiving anti-tuberculous medication (e.g., isoniazid, rifampin, streptomycin, pyrazinamide, or others) * positive cytomegalovirus (cmv) by polymerase chain reaction (pcr) assay * transformation to aggressive lymphoma (e.g., richter's syndrome) * past history of anaphylaxis following exposure to humanized monoclonal antibodies * previous treatment with alemtuzumab * previous hematopoietic stem cell transplant * pregnant or breast-feeding patients * central nervous system (cns) involvement with cll * other severe, concurrent diseases (e.g., cardiac or pulmonary disease), mental disorders, or major organ malfunction (e.g., liver, kidney) that could interfere with the patient's ability to participate in the study * medical condition requiring chronic use of oral corticosteroids at a dose higher than physiologic replacement. * active malignancy, other than cll, which needs therapy with anti-cancer drug(s) * autoimmune anemia and/or thrombocytopenia * small lymphocytic lymphoma

Keywords: relapsed or refractory chronic lymphocytic leukemia, cll