Alemtuzumab and Rituximab in Aplastic Anemia

Low-doses Alemtuzumab and Rituximab Combination as First Line Treatment in Aplastic Anemia

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01408342

Enrollment

Registered

2011-08-03

Start date

2011-07-31

Completion date

2014-01-31

Last updated

2014-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aplastic Anemia

Keywords

Alemtuzumab, Rituximab, Aplastic anemia, cyclosporine

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.

Interventions

DRUGAlemtuzumab and Rituximab

* 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 design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Months to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Evaluate efficacy of alemtuzumab and rituximab in aplastic anemia.	12 months	Evaluate the hematological response after the administration of alemtuzumab and rituximab

Secondary

Measure	Time frame
Measuring the side effects of alemtuzumab and rituximab combination through clinical evaluation	12 months

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026