Chronic Lymphocytic LeukemiaNCT00836043
Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia
An observational study of Chronic Lymphocytic Leukemia, run by Genzyme, a Sanofi Company at 3 sites in 3 countries.
Trial summary
This study will collect data on safety, effectiveness and patient acceptance of MabCampath treatment under daily life conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Alemtuzumab (MabCampath)
- Type of treatment
- Injection or infusion
- How many people
- 6 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2008to Apr 2009
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients,who are suffering from chronic lymphocytic leukemia (CLL) and are treated with alemtuzumab (MabCampath)
Who may be able to join
- In- and outpatients suffering from CLL, who are treated with Mab Campath, and are routinely monitored with PCR (Polymerase Chain Reaction) for CMV infection during MabCampath treatment and for at least 2 months following completion of treatment.
Who cannot join
- In accordance with Summaries of Product Characteristics (SPC).
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia (CLL)
This study will collect data on safety, effectiveness and patient acceptance of MabCampath treatment under daily life conditions.
Read the detailed description
As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Alemtuzumab (MabCampath)
- Keywords
- CLL, alemtuzumab
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alemtuzumab (MabCampath)Drug
Also called BAY86-5045
Intravenous therapy according to product information.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Alemtuzumab (MabCampath) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy related variables are patient's condition, physician's assessment of efficacy and tolerability, information whether application could be completed, clinical and laboratory findings. Safety Variables.
Measured: After first cycle of treatment, e.g. 12 weeks, then after 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startOct 2008
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Study terminated due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836043
- Sponsor's protocol ID
- 13418
- Other IDs
- 13858, 14241, MC0701, STAR
- Status last verified
- Dec 2013
- First submitted
- 2 Feb 2009
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Effectiveness and Patient Acceptance of the Treatment With MabCampath in Chronic Lymphocytic Leukemia (CLL)
- ClinicalTrials.gov ID
- NCT00836043
- Acronym / sponsor ID
- 13418
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- CLL, alemtuzumab
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated due to low enrollment.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will collect data on safety, effectiveness and patient acceptance of MabCampath treatment under daily life conditions.
Detailed description
As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Alemtuzumab (MabCampath) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients,who are suffering from chronic lymphocytic leukemia (CLL) and are treated with alemtuzumab (MabCampath)
Key inclusion criteria (1 listed)
- In- and outpatients suffering from CLL, who are treated with Mab Campath, and are routinely monitored with PCR (Polymerase Chain Reaction) for CMV infection during MabCampath treatment and for at least 2 months following completion of treatment.
Key exclusion criteria (1 listed)
- In accordance with Summaries of Product Characteristics (SPC).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alemtuzumab (MabCampath)Also: BAY86-5045Intravenous therapy according to product information. | Drug | Group 1 |
Primary outcome
Efficacy related variables are patient's condition, physician's assessment of efficacy and tolerability, information whether application could be completed, clinical and laboratory findings. Safety Variables.
Time frame: After first cycle of treatment, e.g. 12 weeks, then after 9 months
Results and safety
The study was stopped early (reason given: Study terminated due to low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Genzyme, a Sanofi Company
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by Genzyme, a Sanofi Company at 3 sites in 3 countries.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 3 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Bosnia and Herzegovina, Israel, North Macedonia. 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.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to low enrollment.). Results are not available in the source record.
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?
Efficacy related variables are patient's condition, physician's assessment of efficacy and tolerability, information whether application could be completed, clinical and laboratory findings. Safety Variables. (time frame: After first cycle of treatment, e.g. 12 weeks, then after 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2013.