A Safety Confirmatory Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
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ClinicalTrials.gov Identifier: NCT00923182 |
Recruitment Status
:
Completed
First Posted
: June 18, 2009
Last Update Posted
: April 30, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Leukemia, Lymphocytic, Chronic, B-Cell | Drug: alemtuzumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Japanese Phase I Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | August 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Alemtuzumab
The starting dose of alemtuzumab was 3 mg. The dose was gradually escalated on a daily basis (3 mg, 10 mg, and then 30 mg) until the patient tolerated a dose of 30 mg IV infusion over 2 hours. All subsequent doses of alemtuzumab were 30 mg IV 3 times a week (every other day).
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Drug: alemtuzumab
Other Name: MabCampath, BAY86-5045, CAMPATH-1H
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- 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 ]
- 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 ]
- 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 ]
- 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 ]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 ]
- 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 ]

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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923182
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 |
Study Director: | Medical Monitor | Genzyme, a Sanofi Company |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Genzyme, a Sanofi Company |
ClinicalTrials.gov Identifier: | NCT00923182 History of Changes |
Other Study ID Numbers: |
CAMCLL07709 14020 |
First Posted: | June 18, 2009 Key Record Dates |
Last Update Posted: | April 30, 2015 |
Last Verified: | April 2015 |
Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Relapsed or Refractory Chronic Lymphocytic Leukemia, CLL |
Additional relevant MeSH terms:
Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Alemtuzumab Antineoplastic Agents |