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Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00749112
Enrollment
19
Registered
2008-09-09
Start date
2008-08-31
Completion date
2010-08-31
Last updated
2010-08-30

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

Conditions

Anemia, Hemolytic, Autoimmune, Idiopathic Thrombocytopenic Purpura

Keywords

Idiopathic Thrombocytopenic Purpura, Anemia, Hemolytic, Autoimmune, Alemtuzumab, Rituximab

Brief summary

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.

Detailed 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.

Interventions

DRUGAlemtuzumab, Rituximab

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

Sponsors

Hospital Universitario Dr. Jose E. Gonzalez
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Objective response rate (CR: complete remission, PR: partial remission, relapse rate.1, 2, 4 and 6 months

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026