Alemtuzumab and Rituximab in Aplastic Anemia

Hospital Universitario Dr. Jose E. Gonzalez

Overview

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Aplastic Anemia

Interventions

Alemtuzumab and RituximabDRUG

* Alemtuzumab 10 mg (5 mg/m2 in patients under 30 kg weight) subcutaneous days 1,2 and 3 * Rituximab 100 mg (50 mg/m2 in patients under 30 kg weight)intravenous days 4,11,18,25 * Cyclosporine 3 mg/kg starting day 21

Eligibility

Sex: ALLMin age: 12 Months

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario, Dr. Jose E. Gonzalez

Monterrey, Nuevo León, Mexico

Outcomes

Primary Outcomes

Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia.

Evaluate the hematological response after the administration of alemtuzumab and rituximab

Time frame: 12 months

Secondary Outcomes

Measuring the side effects of alemtuzumab and rituximab combination through clinical evaluation

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.