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Infections Associated With the Use of Alemtuzumab

This study has been completed.
Sponsor:
Collaborators:
National Taiwan University Hospital
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
ClinicalTrials.gov Identifier:
NCT01315457
First received: March 13, 2011
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  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:

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

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Infectious event [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   15 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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

No publications provided

Responsible Party: Won Seog Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01315457     History of Changes
Other Study ID Numbers: 2009-03-006
Study First Received: March 13, 2011
Last Updated: May 22, 2012
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

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

Additional relevant MeSH terms:
Alemtuzumab
Campath 1G
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013