Alemtuzumab and Rituximab in Aplastic Anemia

Not Applicable

Withdrawn

• Conditions: Aplastic Anemia
• Interventions: Drug: Alemtuzumab and Rituximab

• Registration Number: NCT01408342
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

Brief Summary

The purpose of the study is to evaluate the efficacy of combination of alemtuzumab and rituximab as first line therapy in aplastic anemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-29
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Primary Completion: 2013-01
• Status Verified: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-03
• Last Update Posted: 2014-01-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with aplastic anemia diagnosis

Exclusion Criteria

• Patients with prior treatment with monoclonal antibodies and/or antithymocyte globulin.
• Patients with a diagnosis or history of HIV/AIDS, Hepatitis B, Hepatitis C, Cytomegalovirus.
• Patients who do not agree to sign a Letter of Informed Consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab, Alemtuzumab	Alemtuzumab and Rituximab	-

Primary Outcome Measures

Name	Time	Method
Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia.	12 months	Evaluate the hematological response after the administration of alemtuzumab and rituximab

Secondary Outcome Measures

Name	Time	Method
Measuring the side effects of alemtuzumab and rituximab combination through clinical evaluation	12 months

Trial Locations

Locations (1)

Hospital Universitario, Dr. Jose E. Gonzalez; 🇲🇽 Monterrey, Nuevo Leon, Mexico