NCT01408342WithdrawnNot Applicable
Low-doses Alemtuzumab and Rituximab Combination as First Line Treatment in Aplastic Anemia
Hospital Universitario Dr. Jose E. Gonzalez1 site in 1 countryStarted: July 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Months to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Rituximab, Alemtuzumab
Other
Intervention: Alemtuzumab and Rituximab (Drug)
Outcomes
Primary Outcomes
Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia.
Time Frame: 12 months
Evaluate the hematological response after the administration of alemtuzumab and rituximab
Secondary Outcomes
- Measuring the side effects of alemtuzumab and rituximab combination through clinical evaluation(12 months)
Investigators
David Gomez Almaguer
MD
Hospital Universitario Dr. Jose E. Gonzalez
Study Sites (1)
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