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Infections Associated With the Use of Alemtuzumab

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ClinicalTrials.gov Identifier: NCT01315457
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : May 24, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease
Patients Treated With Alemtuzumab

Study Design

Study Type : Observational
Actual Enrollment : 182 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Asian Multinational Retrospective Analysis for Infectious Complications in Patients Treated With Alemtuzumab
Study Start Date : April 2009
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Alemtuzumab
Patients treated with alemtuzumab


Outcome Measures

Primary Outcome Measures :
  1. Infectious event [ Time Frame: one year ]
    Any infectious complication occurred within one year after the use of alemtuzumab


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients received alemtuzumab as a treatment for hematologic malignancy
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients did not receive alemtuzumab
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315457


Locations
China
Queen Mary Hospital
Hong Kong, China
Indonesia
Cipto Mangunkusumo General Hospital
Jakarta, Indonesia
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Taiwan
National Taiwan University Hospital
Teipei, Taiwan
Thailand
Chulalongkorn University
Bangkok, Thailand
Sponsors and Collaborators
Samsung Medical Center
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
Investigators
Principal Investigator: Won Seog Kim, MD, PhD Samsung Medical Center
More Information

Responsible Party: Won Seog Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01315457     History of Changes
Other Study ID Numbers: 2009-03-006
First Posted: March 15, 2011    Key Record Dates
Last Update Posted: May 24, 2012
Last Verified: May 2012

Keywords provided by Won Seog Kim, Samsung Medical Center:
alemtuzumab, infection, prophylaxis, treatment

Additional relevant MeSH terms:
Alemtuzumab
Antineoplastic Agents