Leukemia, Lymphocytic, Chronic, B-Cell
Conditions
Keywords
Relapsed or Refractory Chronic Lymphocytic Leukemia,, CLL
Brief 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).
Detailed description
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.
Interventions
DRUGalemtuzumab
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety profile: As measured by physical examinations, vital signs, adverse events, concomitant medications and laboratory tests | Until 24 weeks after end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate: Defined as the proportion of patients who achieved complete remission (CR) or partial remission (PR) as the best response according to the investigator's determination using the NCIWG response criteria | Until 24 weeks after end of treatment | — |
| Pharmacokinetic profiles: Area under the serum concentration vs time curve over the dosing interval, Maximum drug concentration in serum, terminal elimination half-life following the last dose, total body clearance and volume of distribution | until 24 weeks after end of treatment | — |
| Time to response: Defined as the time from date of initial treatment until first objective documentation of response (CR or PR) as determined by the investigator. | Until 24 weeks after end of treatment | If a patient achieves PR before CR, the onset date of PR will be used in the calculation |
| Duration of response: Defined as the time from first objective documentation of response (CR or PR) by the investigator to first objective documentation of progressive disease by the investigator | Until 24 weeks after end of treatment | — |
| Time to progression: Defined as the time from date of initial treatment to first objective documentation of progressive disease by the investigator | Until 24 weeks after end of treatment | — |
Countries
Japan
Outcome results
None listed