Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase

Completed

Phase 3

Phase 2

Conditions

Anemia, Hemolytic, Autoimmune

Idiopathic Thrombocytopenic Purpura

Treatments

Drug: Alemtuzumab, Rituximab

Study type

Interventional

Funder types

Other

Identifiers

NCT00749112

HE08-004

Details and patient eligibility

About

The purpose of this study is to determine whether the combination of low doses of alemtuzumab and rituximab are effective in the treatment of patients with autoimmune cytopenias who has failed on steroids, relapsed after steroids withdrawal or required continuous steroids treatment.

Full description

Autoimmune cytopenias are a common entities with good responses to steroids therapies as first line, but there is a considerable percentage of patients who relapse, become refractory or dependant on steroids to maintain an acceptable level of hemoglobin or platelets, and the treatment becomes more difficult increasing the secondary effects. The current study evaluates the safety and efficacy of the combination of low doses of alemtuzumab (anti CD52) and Rituximab (anti CD 20) as a second line treatment option for this subset of patients improving the cytopenias without increasing the adverse effects.

Enrollment

19 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age: > or = 16 years
Weight: more than 40 Kg
Autoimmune Hemolytic anemia with clinical and biochemical evidence of hemolysis refractory to treatment, in relapse or steroids dependant
Idiopathic thrombocytopenic purpura with platelet counts < 50,000, refractory to treatment, in relapse or steroids dependant

Exclusion criteria