Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

Idiopathic Thrombocytopenic Purpura Clinical Trial

Official title:

Low Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749112
• Other study ID #: HE08-004
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 8, 2008
• Last updated: August 27, 2010
• Start date: August 2008
• Est. completion date: August 2010

Study information

• Verified date: August 2010
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Idiopathic Thrombocytopenic Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• Alemtuzumab, Rituximab
Alemtuzumab 10 mg each 24 hrs subcutaneous for 3 days. Rituximab 100 mg IV every week for 4 weeks.

Locations

Country	Name	City	State
Mexico	Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer	Monterrey	Nuevo Leon

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (CR: complete remission, PR: partial remission, relapse rate.		1, 2, 4 and 6 months	Yes