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

Leukemia, Lymphocytic, Chronic, B-Cell Clinical Trial

Official title:

A Japanese Phase I Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00923182
• Other study ID #: CAMCLL07709
• Secondary ID: 14020
• Status: Completed
• Phase: Phase 1
• First received: June 9, 2009
• Last updated: April 29, 2015
• Start date: February 2010
• Est. completion date: August 2011

Study information

• Verified date: April 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• alemtuzumab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety profile: As measured by physical examinations, vital signs, adverse events, concomitant medications and laboratory tests		Until 24 weeks after end of treatment	Yes
Secondary	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	No
Secondary	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	No
Secondary	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.	If a patient achieves PR before CR, the onset date of PR will be used in the calculation	Until 24 weeks after end of treatment	No
Secondary	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	No
Secondary	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	No