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Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

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ClinicalTrials.gov Identifier: NCT00749112
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : August 30, 2010
Sponsor:
Information provided by:
Hospital Universitario Dr. Jose E. Gonzalez

Brief Summary:
The purpose of this study is to determine whether the combination of low doses of alemtuzumab and rituximab are effective in the treatment of patients with autoimmune cytopenias who has failed on steroids, relapsed after steroids withdrawal or required continuous steroids treatment.

Condition or disease Intervention/treatment Phase
Idiopathic Thrombocytopenic Purpura Anemia, Hemolytic, Autoimmune Drug: Alemtuzumab, Rituximab Phase 2 Phase 3

Detailed Description:
Autoimmune cytopenias are a common entities with good responses to steroids therapies as first line, but there is a considerable percentage of patients who relapse, become refractory or dependant on steroids to maintain an acceptable level of hemoglobin or platelets, and the treatment becomes more difficult increasing the secondary effects. The current study evaluates the safety and efficacy of the combination of low doses of alemtuzumab (anti CD52) and Rituximab (anti CD 20) as a second line treatment option for this subset of patients improving the cytopenias without increasing the adverse effects.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias
Study Start Date : August 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010


Arm Intervention/treatment
Experimental: A Drug: Alemtuzumab, Rituximab
Alemtuzumab 10 mg each 24 hrs subcutaneous for 3 days. Rituximab 100 mg IV every week for 4 weeks.
Other Names:
  • campath
  • mabthera




Primary Outcome Measures :
  1. Objective response rate (CR: complete remission, PR: partial remission, relapse rate. [ Time Frame: 1, 2, 4 and 6 months ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: > or = 16 years
  • Weight: more than 40 Kg
  • Autoimmune Hemolytic anemia with clinical and biochemical evidence of hemolysis refractory to treatment, in relapse or steroids dependant
  • Idiopathic thrombocytopenic purpura with platelet counts < 50,000, refractory to treatment, in relapse or steroids dependant

Exclusion Criteria:

  • Current viral or bacterial infection.
  • Positive serology for HIV, HCV, HBV.

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): NCT00749112


Locations
Mexico
Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Principal Investigator: David Gomez-Almaguer, MD Hospital Universitario Dr. Jose E. Gonzalez

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Gomez-Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT00749112     History of Changes
Other Study ID Numbers: HE08-004
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: August 30, 2010
Last Verified: August 2010

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
Idiopathic Thrombocytopenic Purpura
Anemia
Hemolytic
Autoimmune
Alemtuzumab
Rituximab

Additional relevant MeSH terms:
Rituximab
Purpura
Purpura, Thrombocytopenic
Hemolysis
Purpura, Thrombocytopenic, Idiopathic
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Anemia
Alemtuzumab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents