Patients Treated With AlemtuzumabNCT01315457
Infections Associated With the Use of Alemtuzumab
An observational study of Patients Treated With Alemtuzumab, run by Samsung Medical Center at 5 sites in 5 countries.
Trial summary
The aim of this study is to propose infection prophylaxis from Asian multinational retrospective analysis of infectious complications in patients who were treated with alemtuzumab Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Patients Treated With Alemtuzumab
- How many people
- 182 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Apr 2009to Mar 2012
- 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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients received alemtuzumab as a treatment for hematologic malignancy
Who may be able to join
- Patients received alemtuzumab as a treatment for hematologic malignancy ex. non-Hodgkin lymphoma Acute myeloid leukemia Aplastic anemia
Who cannot join
- Patients did not receive alemtuzumab
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: Asian Multinational Retrospective Analysis for Infectious Complications in Patients Treated With Alemtuzumab
The aim of this study is to propose infection prophylaxis from Asian multinational retrospective analysis of infectious complications in patients who were treated with alemtuzumab
- Conditions
- Patients Treated With Alemtuzumab
- Keywords
- alemtuzumab, infection, prophylaxis, treatment
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alemtuzumab | Patients treated with alemtuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infectious event
Any infectious complication occurred within one year after the use of alemtuzumab
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startApr 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Treated With AlemtuzumabStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Dr Cipto Mangunkusumo General Hospital, Asan Medical Center, Soon Chun Hyang University, Chonnam National University, Chonbuk National University, Chulalongkorn University, Queen Mary Hospital, Hong Kong, Yonsei University, Kyungpook National University Hospital
- Responsible party
- Principal investigator, Won Seog Kim, Samsung Medical Center
- Investigators
- Won Seog Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315457
- Sponsor's protocol ID
- 2009-03-006
- Status last verified
- May 2012
- First submitted
- 13 Mar 2011
- Last updated
- 24 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asian Multinational Retrospective Analysis for Infectious Complications in Patients Treated With Alemtuzumab
- ClinicalTrials.gov ID
- NCT01315457
- Acronym / sponsor ID
- 2009-03-006
- Conditions
- Patients Treated With Alemtuzumab
- Keywords
- alemtuzumab, infection, prophylaxis, treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Dr Cipto Mangunkusumo General Hospital, Asan Medical Center, Soon Chun Hyang University, Chonnam National University, Chonbuk National University, Chulalongkorn University, Queen Mary Hospital, Hong Kong, Yonsei University, Kyungpook National University Hospital
- Study start
- Apr 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Mar 2011 (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.
The aim of this study is to propose infection prophylaxis from Asian multinational retrospective analysis of infectious complications in patients who were treated with alemtuzumab
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alemtuzumab | – | –Patients treated with alemtuzumab |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients received alemtuzumab as a treatment for hematologic malignancy
Key inclusion criteria (1 listed)
- Patients received alemtuzumab as a treatment for hematologic malignancy ex. non-Hodgkin lymphoma Acute myeloid leukemia Aplastic anemia
Key exclusion criteria (1 listed)
- Patients did not receive alemtuzumab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Infectious event
Time frame: one year
Any infectious complication occurred within one year after the use of alemtuzumab
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2012.
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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.
Won Seog Kim, MD, PhD principal investigator
Samsung Medical Center
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Treated With Alemtuzumab, run by Samsung Medical Center at 5 sites in 5 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: finished, as of the sponsor's last update on 24 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China, Indonesia, South Korea, Taiwan, Thailand. 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 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?
Infectious event (time frame: one year). 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 24 May 2012.