A Safety Confirmatory Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00923182
First received: June 9, 2009
Last updated: January 3, 2012
Last verified: January 2012

June 9, 2009
January 3, 2012
February 2010
August 2011   (final data collection date for primary outcome measure)
Safety profile: As measured by physical examinations, vital signs, adverse events, concomitant medications and laboratory tests [ Time Frame: Until 24 weeks after end of treatment ] [ Designated as safety issue: Yes ]
Safety profile: Results of physical examinations, vital signs, adverse events, concomitant medications and abnormal laboratory tests will be summarized [ Time Frame: Unitil 24 weeks after end of treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00923182 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: Until 24 weeks after end of treatment ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: until 24 weeks after end of treatment ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Until 24 weeks after end of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Until 24 weeks after end of treatment ] [ Designated as safety issue: No ]
  • Time to progression: Defined as the time from date of initial treatment to first objective documentation of progressive disease by the investigator [ Time Frame: Until 24 weeks after end of treatment ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: Unitil 24 weeks after end of treatment ] [ Designated as safety issue: No ]
  • Pharmacokinetic profiles: Area under the serum concentration vs time curve (AUC), AUC during mean dose interval, Maximum drug concentration in serum [ Time Frame: unitil 10 weeks after end of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Safety Confirmatory Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
A Japanese Phase I Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia, Lymphocytic, Chronic, B-Cell
Drug: alemtuzumab
The starting dose of alemtuzumab will be 3mg. The dose will be gradually escalated on a daily basis (3mg, 10mg and then 30mg) during Week 1 (continued as necessary in Week 2) until the patient tolerates a dose of 30mg intravenous (IV) infusion over 2 hours. All subsequent doses of alemtuzumab will be 30mg IV 3 times a week(every other day) for a maximum of 12 weeks.
Other Name: MabCampath, BAY86-5045, CAMPATH-1H
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00923182
CAMCLL07709, 14020
Yes
Genzyme, a Sanofi Company
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
Genzyme, a Sanofi Company
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP