Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

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.

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Key information

Conditions

Idiopathic Thrombocytopenic Purpura Anemia Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemolysis Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer

Monterrey, Nuevo León, 64460, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Current viral or bacterial infection.
Positive serology for HIV, HCV, HBV.

Treatment and study plan

Alemtuzumab, Rituximab

Drug

Alemtuzumab 10 mg each 24 hrs subcutaneous for 3 days. Rituximab 100 mg IV every week for 4 weeks.

Other names: campath, mabthera

Primary outcomes

Objective response rate (CR: complete remission, PR: partial remission, relapse rate.

Time frame: 1, 2, 4 and 6 months

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Official study title

Low Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Sep 9, 2008
Registry last updated: Aug 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed