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Infections Associated With the Use of Alemtuzumab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01315457
First Posted: March 15, 2011
Last Update Posted: May 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center
  Purpose
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
Patients Treated With Alemtuzumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Asian Multinational Retrospective Analysis for Infectious Complications in Patients Treated With Alemtuzumab

Resource links provided by NLM:


Further study details as provided by Won Seog Kim, Samsung Medical Center:

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


Enrollment: 182
Study Start Date: April 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Alemtuzumab
Patients treated with alemtuzumab

  Eligibility

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 Submitted: March 13, 2011
First Posted: March 15, 2011
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