Alemtuzumab and Rituximab in Aplastic Anemia

Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Study ID
NCT01408342
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Months - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alemtuzumab and Rituximab — DRUG
    * 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

Study Details

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

Key Dates

Start date
Jul 31, 2011
Status verified
Jan 2014
Primary completion
Jan 31, 2013
Completion
Jan 31, 2014

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Rituximab, Alemtuzumab

Primary Outcome Measure

Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia. [ Time Frame: 12 months ]

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