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

Study Description

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Brief 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).

Condition or disease	Intervention/treatment	Phase
Leukemia, Lymphocytic, Chronic, B-Cell	Drug: alemtuzumab	Phase 1

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.

Study Design

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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

Arms and Interventions

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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).	Drug: alemtuzumab; Other Name: MabCampath, BAY86-5045, CAMPATH-1H

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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
4. 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 ]
5. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ishizawa K, Fukuhara N, Nakaseko C, Chiba S, Ogura M, Okamoto A, Sunaga Y, Tobinai K. Safety, efficacy and pharmacokinetics of humanized anti-CD52 monoclonal antibody alemtuzumab in Japanese patients with relapsed or refractory B-cell chronic lymphocytic leukemia. Jpn J Clin Oncol. 2017 Jan;47(1):54-60. doi: 10.1093/jjco/hyw146. Epub 2016 Oct 7.

Responsible Party:	Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:	NCT00923182 History of Changes
Other Study ID Numbers:	CAMCLL07709; 14020
First Posted:	June 18, 2009
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