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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
Phramongkutklao College of Medicine and Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Cytopenias focused on measuring Alemtuzumab in autoimmune cytopenias

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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

  2. Patients must have refractory disease according to the following criteria

    1. not respond to steroids or
    2. need prednisolone more than 15 mg/d for maintenance therapy
  3. Complete work up for baseline evaluation and measurement
  4. Age > 18 years
  5. Patient's free written inform consent

Exclusion Criteria:

  1. Patients with a known hypersensitivity to murine proteins or to any component of alemtuzumab
  2. Patients with poor performance status (ECOG criteria of 3-4)
  3. Serologic evidence of human immunodeficiency virus exposure
  4. Patients with active uncontrolled infection. Patients that are HIV positive or test positive on HBs or HCV antigens.
  5. Pregnant or lactating women
  6. Serious medical or psychiatric illness which prevent informed consent
  7. Patients who are likely to lost to follow up (eg, unwilling or difficult to return, cannot be contacted)
  8. 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

First Posted
April 25, 2007
Last Updated
June 18, 2009
Sponsor
Phramongkutklao College of Medicine and Hospital
Collaborators
Bayer
search

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

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The Efficacy and Safety of Alemtuzumab in Auotoimmune Cytopenias

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