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The Efficacy and Safety of Alemtuzumab in Auotoimmune Cytopenias

This study has been terminated.
(no eligible patient)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00472433
First Posted: May 11, 2007
Last Update Posted: June 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bayer
Information provided by:
Phramongkutklao College of Medicine and Hospital
  Purpose
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.

Condition Intervention Phase
Autoimmune Cytopenias Drug: Alemtuzumab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Alemtuzumab in Autoimmune Cytopenias

Resource links provided by NLM:


Further study details as provided by Phramongkutklao College of Medicine and Hospital:

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.

Estimated Enrollment: 30
Study Start Date: March 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472433


Locations
Thailand
Phramongkutklao Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Phramongkutklao College of Medicine and Hospital
Bayer
Investigators
Principal Investigator: Wichean Mongkonsritragoon, M.D. Phramongkutklao College of Medicine and Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00472433     History of Changes
Other Study ID Numbers: TH011003
First Submitted: April 25, 2007
First Posted: May 11, 2007
Last Update Posted: June 22, 2009
Last Verified: June 2009

Keywords provided by Phramongkutklao College of Medicine and Hospital:
Alemtuzumab in autoimmune cytopenias

Additional relevant MeSH terms:
Anemia
Leukopenia
Thrombocytopenia
Hematologic Diseases
Leukocyte Disorders
Blood Platelet Disorders
Alemtuzumab
Antineoplastic Agents