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A Phase II Study of Alemtuzumab in Autoimmune Cytopenias

Phase 2
18 Years
Not Enrolling
Autoimmune Cytopenias

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Trial Information

A Phase II Study of Alemtuzumab in Autoimmune Cytopenias

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Wichean Mongkonsritragoon, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Phramongkutklao College of Medicine and Hospital


Thailand: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

May 2009

Related Keywords:

  • Autoimmune Cytopenias
  • Alemtuzumab in autoimmune cytopenias
  • Anemia
  • Leukopenia
  • Pancytopenia
  • Thrombocytopenia