Brief Title
Alemtuzumab and Rituximab in Aplastic Anemia
Official Title
Low-doses Alemtuzumab and Rituximab Combination as First Line Treatment in Aplastic Anemia
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.
Study Type
Interventional
Primary Outcome
Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia.
Secondary Outcome
Measuring the side effects of alemtuzumab and rituximab combination through clinical evaluation
Condition
Aplastic Anemia
Intervention
Alemtuzumab and Rituximab
Study Arms / Comparison Groups
Rituximab, Alemtuzumab
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
July 2011
Completion Date
January 2014
Primary Completion Date
January 2013
Eligibility Criteria
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.
Gender
All
Ages
12 Months - N/A
Accepts Healthy Volunteers
No
Contacts
David Gomez Almaguer, MD, ,
Location Countries
Mexico
Location Countries
Mexico
Administrative Informations
NCT ID
NCT01408342
Organization ID
HE11015
Secondary IDs
AA
Responsible Party
Principal Investigator
Study Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Study Sponsor
David Gomez Almaguer, MD, Principal Investigator, Hospital Universitario Dr. Jose E. Gonzalez
Verification Date
January 2014