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

April 29, 2015 updated by: Genzyme, a Sanofi Company

A Japanese Phase I Study of Alemtuzumab in Japanese Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan, 260-8677
    • Aichi
      • Nagoya, Aichi, Japan, 466-8650
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Chuo-ku, Tokyo, Japan, 104-0045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • MabCampath, BAY86-5045, CAMPATH-1H

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Until 24 weeks after end of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
Time Frame: Until 24 weeks after end of treatment
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
Until 24 weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genzyme, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAMCLL07709
  • 14020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings