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

NCT00923182 | Completed Phase 1 DMC

• 2 other identifiers: CAMCLL0770914020
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 6

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).

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Keywords

Relapsed or Refractory Chronic Lymphocytic Leukemia,; CLL

Outcome Measures

Primary Outcomes (1)

• Safety profile: As measured by physical examinations, vital signs, adverse events, concomitant medications and laboratory tests

  Until 24 weeks after end of treatment

Secondary Outcomes (5)

• 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

• 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

• 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.

  Until 24 weeks after end of treatment

• 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

• 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

Study Arms (1)

Alemtuzumab

EXPERIMENTAL

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

Interventions

alemtuzumab DRUG

Also known as: MabCampath, BAY86-5045, CAMPATH-1H

Alemtuzumab

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (6)

Unknown Facility

Nagoya, Aichi-ken, 466-8650, Japan

Location

Unknown Facility

Chiba, Chiba, 260-8677, Japan

Location

Unknown Facility

Tsukuba, Ibaraki, 305-8576, Japan

Location

Unknown Facility

Sendai, Miyagi, 980-8574, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, 104-0045, Japan

Location

Related Publications (1)

• 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.

  PMID: 28122892 DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Recurrence

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 18, 2009
• Study Start: February 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 30, 2015

Record last verified: 2015-04

Locations

JP (6)