Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00749112
• Date of registration: 08/09/2008
• Prospective Registration: No
• Primary sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Public title: Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias
• Scientific title: Low Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias
• Date of first enrolment: August 2008
• Target sample size: 19
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00749112
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Mexico

Contacts

• Name: David Gomez-Almaguer, MD
• Affiliation: Hospital Universitario Dr. Jose E. Gonzalez

Key inclusion & exclusion 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.



Age minimum: 16 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic Thrombocytopenic Purpura

Anemia, Hemolytic, Autoimmune

Intervention(s)

Drug: Alemtuzumab, Rituximab

Primary Outcome(s)

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

Secondary ID(s)

HE08-004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors