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TerminatedNCT00472433Updated Jun 22, 2009

The Efficacy and Safety of Alemtuzumab in Auotoimmune Cytopenias

A Phase 2 interventional study of Alemtuzumab in Autoimmune Cytopenias, sponsored by Phramongkutklao College of Medicine and Hospital. Terminated at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-22.

Sponsored by Phramongkutklao College of Medicine and Hospital · Phase 2, Interventional, and Treatment

Why this study was terminated
no eligible patient
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Autoimmune Cytopenias

Keywords

  • Alemtuzumab in autoimmune cytopenias
03

In context

Lead sponsor

Phramongkutklao College of Medicine and Hospital is the lead sponsor of 37 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. To determine the safety profiles of alemtuzumab in patients with autoimmune cytopenias.

07

Study locations

1 site
  • Phramongkutklao Hospital
    Bangkok, 10400, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00472433
Lead sponsor
Phramongkutklao College of Medicine and Hospital
Collaborators
Bayer
First posted
May 11, 2007
Start date
Mar 2007
Primary completion
May 2009
Completion
May 2009
Last update
Jun 22, 2009

Study contacts

Wichean Mongkonsritragoon, M.D.
principal investigator · Phramongkutklao College of Medicine and Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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