The Efficacy and Safety of Alemtuzumab in Auotoimmune Cytopenias
Primary Purpose
Autoimmune Cytopenias
Status
Terminated
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Alemtuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Autoimmune Cytopenias focused on measuring Alemtuzumab in autoimmune cytopenias
Eligibility Criteria
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
Sites / Locations
- Phramongkutklao Hospital
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
To determine the safety profiles of alemtuzumab in patients with autoimmune cytopenias.
Full Information
NCT ID
NCT00472433
First Posted
April 25, 2007
Last Updated
June 18, 2009
Sponsor
Phramongkutklao College of Medicine and Hospital
Collaborators
Bayer
1. Study Identification
Unique Protocol Identification Number
NCT00472433
Brief Title
The Efficacy and Safety of Alemtuzumab in Auotoimmune Cytopenias
Official Title
A Phase II Study of Alemtuzumab in Autoimmune Cytopenias
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Terminated
Why Stopped
no eligible patient
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Phramongkutklao College of Medicine and Hospital
Collaborators
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Cytopenias
Keywords
Alemtuzumab in autoimmune cytopenias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Alemtuzumab
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To determine the safety profiles of alemtuzumab in patients with autoimmune cytopenias.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wichean Mongkonsritragoon, M.D.
Organizational Affiliation
Phramongkutklao College of Medicine and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phramongkutklao Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of Alemtuzumab in Auotoimmune Cytopenias
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