A Safety Confirmatory Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
This study has been completed.
Sponsor:
Genzyme
Information provided by (Responsible Party):
Genzyme
ClinicalTrials.gov Identifier:
NCT00923182
First received: June 9, 2009
Last updated: January 3, 2012
Last verified: January 2012
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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:
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:
Detailed Description:
-
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
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
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
Investigators
| Study Director: | Medical Monitor | Genzyme |
More Information
No publications provided
| Responsible Party: | Genzyme |
| 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:
|
Relapsed or Refractory Chronic Lymphocytic Leukemia, CLL |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Alemtuzumab Campath 1G Antibodies, Neoplasm Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013