Status:
COMPLETED
A Safety Confirmatory Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
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 Lymphocyti...
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00923182
Start Date
February 1 2010
End Date
August 1 2011
Last Update
April 30 2015
Active Locations (6)
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1
Nagoya, Aichi-ken, Japan, 466-8650
2
Chiba, Chiba, Japan, 260-8677
3
Tsukuba, Ibaraki, Japan, 305-8576
4
Sendai, Miyagi, Japan, 980-8574