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Leukemia, Lymphocytic, Chronic, B-CellPhase 1NCT00923182

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

A Phase 1 study testing alemtuzumab in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Genzyme, a Sanofi Company at 6 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Leukemia, Lymphocytic, Chronic, B-Cell
What is being tested?
alemtuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
6 sitesJapan
Study dates
Feb 2010to Aug 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Japan6 sites

  • Study site

    Bunkyo-ku, Tokyo, 113-8519

  • Study site

    Chiba, Chiba, 260-8677

  • Study site

    Chuo-ku, Tokyo, 104-0045

  • Study site

    Nagoya, Aichi-ken, 466-8650

  • Study site

    Sendai, Miyagi, 980-8574

  • Study site

    Tsukuba, Ibaraki, 305-8576

Other trials in Japan

About this study

Official title: 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).

Read the 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.

Being tested
alemtuzumab
Keywords
Relapsed or Refractory Chronic Lymphocytic Leukemia,, CLL
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alemtuzumabDrug

    Also called MabCampath, BAY86-5045, CAMPATH-1H

Study groups in NCT00923182
Study groupRoleWhat they receive
AlemtuzumabExperimentalThe 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).
Receives: Drug: alemtuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Until 24 weeks after end of treatment

Secondary outcomes (5)

  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

    Measured: 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

    Measured: 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.

    If a patient achieves PR before CR, the onset date of PR will be used in the calculation

    Measured: Until 24 weeks after end of treatment

  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

    Measured: 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

    Measured: Until 24 weeks after end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2009 (estimated)
  2. Study startFeb 2010
  3. Primary completionAug 2011
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00923182
Sponsor's protocol ID
CAMCLL07709
Other IDs
14020
Status last verified
Apr 2015
First submitted
9 Jun 2009
Last updated
30 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28122892

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing alemtuzumab in people with Leukemia, Lymphocytic, Chronic, B-Cell, run by Genzyme, a Sanofi Company at 6 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00923182, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.

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