- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00472433
The Efficacy and Safety of Alemtuzumab in Auotoimmune Cytopenias
June 18, 2009 updated by: Phramongkutklao College of Medicine and Hospital
A Phase II Study of Alemtuzumab in Autoimmune Cytopenias
The majority of cases of autoimmune cytopenias, which includes immune thrombocytopenia (ITP), autoimmune hemolytic anemia, autoimmune neutropenia (AIN) and pure red cell aplasia, will respond to conventional immunosuppressive therapy with or without splenectomy.
There is, however, a group of patients with refractory or chronically relapsing autoimmune cytopenias causing life-threatening hemorrhages, infections or anemia.
Further problems include the short- and long-term side-effects of corticosteroids, and the potential toxicity of immunosuppressive and cytotoxic agents.
An alternative and less toxic approach in these patients may be the treatment with Campath-1H, a humanized IgG monoclonal antibody specific for the CD52 antigen and present on human lymphocytes and monocytes.
The main effect of Campath-1H is on T cell and it results in a prolonged and profound depletion of the CD4 and CD8 subpopulations, particularly the CD4 population, and this might "reset" the immune system without the need for total immune ablation.Therefore, this study is designed to investigate safety and efficacy of repeated Campath treatment cycles in autoimmune cytopenia.In order to minimize possible side effects of accumulating Campath, the 3 treatment cycles will be administered in consecutively reduced doses.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bangkok, Thailand, 10400
- Phramongkutklao Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Patients must have a diagnosis of the following autoimmune cytopenias:
immune thromobocytopenia purpura (ITP) autoimmune hemolytic anemia (AIHA) autoimmune neutropenia (AIN) pure red cell aplasia (PRCA) and
Patients must have refractory disease according to the following criteria
- not respond to steroids or
- need prednisolone more than 15 mg/d for maintenance therapy
- Complete work up for baseline evaluation and measurement
- Age > 18 years
- Patient's free written inform consent
Exclusion Criteria:
- Patients with a known hypersensitivity to murine proteins or to any component of alemtuzumab
- Patients with poor performance status (ECOG criteria of 3-4)
- Serologic evidence of human immunodeficiency virus exposure
- Patients with active uncontrolled infection. Patients that are HIV positive or test positive on HBs or HCV antigens.
- Pregnant or lactating women
- Serious medical or psychiatric illness which prevent informed consent
- Patients who are likely to lost to follow up (eg, unwilling or difficult to return, cannot be contacted)
- Patients with active malignancies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To investigate the efficacy of alemtuzumab in terms of objective response rate (ORR: complete remission [CR], partial remission [PR]), progression free survival (PFS), and relapse rate in patients with autoimmune cytopenias
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Secondary Outcome Measures
Outcome Measure |
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To determine the safety profiles of alemtuzumab in patients with autoimmune cytopenias.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Wichean Mongkonsritragoon, M.D., Phramongkutklao College of Medicine and Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
April 25, 2007
First Submitted That Met QC Criteria
May 10, 2007
First Posted (Estimate)
May 11, 2007
Study Record Updates
Last Update Posted (Estimate)
June 22, 2009
Last Update Submitted That Met QC Criteria
June 18, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TH011003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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