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CompletedNCT01315457Updated May 24, 2012

Infections Associated With the Use of Alemtuzumab

An observational study in Patients Treated With Alemtuzumab, sponsored by Samsung Medical Center. Completed at 5 sites in 5 countries. Open to participants aged 15 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-05-24.

Sponsored by Samsung Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
182
Ages
15 Years to 90 Years
Sex
All
01

Study 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

02

Conditions studied

  • Patients Treated With Alemtuzumab

Keywords

  • alemtuzumab, infection, prophylaxis, treatment
03

In context

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients received alemtuzumab as a treatment for hematologic malignancy

Inclusion criteria

  • Patients received alemtuzumab as a treatment for hematologic malignancy ex. non-Hodgkin lymphoma Acute myeloid leukemia Aplastic anemia

Exclusion criteria

Exclusion Criteria:

  • Patients did not receive alemtuzumab
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
182 participants (actual)

Groups and cohorts

  • Alemtuzumab

    Patients treated with alemtuzumab

06

What researchers measure

Primary outcomes

  1. Infectious event

    Any infectious complication occurred within one year after the use of alemtuzumab

    Time frame: one year

07

Study locations

5 sites
  • Queen Mary Hospital
    Hong Kong, China
  • Cipto Mangunkusumo General Hospital
    Jakarta, Indonesia
  • Samsung Medical Center
    Seoul, Korea, Republic of
  • National Taiwan University Hospital
    Teipei, Taiwan
  • Chulalongkorn University
    Bangkok, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01315457
Lead sponsor
Samsung Medical Center
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
Won Seog Kim (Professor, Samsung Medical Center) — Principal investigator
First posted
Mar 15, 2011
Start date
Apr 2009
Primary completion
Mar 2012
Completion
Mar 2012
Last update
May 24, 2012

Study contacts

Won Seog Kim, MD, PhD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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