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
  Purpose

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).


Condition Intervention Phase
Leukemia, Lymphocytic, Chronic, B-Cell
Drug: alemtuzumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Japanese Phase I Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 6
Study Start Date: February 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923182

Locations
Japan
Nagoya, Aichi, Japan, 466-8650
Tsukuba, Ibaraki, Japan, 305-8576
Sendai, Miyagi, Japan, 980-8574
Bunkyo-ku, Tokyo, Japan, 113-8519
Chuo-ku, Tokyo, Japan, 104-0045
Chiba, Japan, 260-8677
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00923182     History of Changes
Other Study ID Numbers: CAMCLL07709, 14020
Study First Received: June 9, 2009
Last Updated: January 3, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Genzyme, a Sanofi Company:
Relapsed or Refractory Chronic Lymphocytic Leukemia,
CLL

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Alemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014