NCT01315457

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2009

Typical duration for all trials

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 24, 2012

Status Verified

May 1, 2012

Enrollment Period

2.9 years

First QC Date

March 13, 2011

Last Update Submit

May 22, 2012

Conditions

Patients Treated With Alemtuzumab

Keywords

alemtuzumab, infection, prophylaxis, treatment

Outcome Measures

Primary Outcomes (1)

  • Infectious event

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

    one year

Study Arms (1)

Alemtuzumab

Patients treated with alemtuzumab

Eligibility Criteria

Age15 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients received alemtuzumab as a treatment for hematologic malignancy

You may qualify if:

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

You may not qualify if:

  • Patients did not receive alemtuzumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Queen Mary Hospital

Hong Kong, China

Location

Cipto Mangunkusumo General Hospital

Jakarta, Indonesia

Location

Samsung Medical Center

Seoul, South Korea

Location

National Taiwan University Hospital

Teipei, Taiwan

Location

Chulalongkorn University

Bangkok, Thailand

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Won Seog Kim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 13, 2011

First Posted

March 15, 2011

Study Start

April 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 24, 2012

Record last verified: 2012-05

Locations

KR(1)CN(1)ID(1)TW(1)TH(1)