Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias
This study has been completed.
Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Information provided by:
Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT00749112
First received: September 8, 2008
Last updated: August 27, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Idiopathic Thrombocytopenic Purpura Anemia, Hemolytic, Autoimmune |
Drug: Alemtuzumab, Rituximab |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Low Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias |
Resource links provided by NLM:
Genetics Home Reference related topics:
thrombotic thrombocytopenic purpura
MedlinePlus related topics:
Anemia
U.S. FDA Resources
Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:
Primary Outcome Measures:
- Objective response rate (CR: complete remission, PR: partial remission, relapse rate. [ Time Frame: 1, 2, 4 and 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 19 |
| Study Start Date: | August 2008 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Alemtuzumab, Rituximab
Alemtuzumab 10 mg each 24 hrs subcutaneous for 3 days. Rituximab 100 mg IV every week for 4 weeks.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749112
Locations
| Mexico | |
| Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer | |
| Monterrey, Nuevo Leon, Mexico, 64460 | |
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
| Principal Investigator: | David Gomez-Almaguer, MD | Hospital Universitario Dr. Jose E. Gonzalez |
More Information
No publications provided by Hospital Universitario Dr. Jose E. Gonzalez
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | David Gomez-Almaguer, Hospital Universitario Dr. Jose E. Gonzalez |
| ClinicalTrials.gov Identifier: | NCT00749112 History of Changes |
| Other Study ID Numbers: | HE08-004 |
| Study First Received: | September 8, 2008 |
| Last Updated: | August 27, 2010 |
| Health Authority: | Mexico: Ethics Committee |
Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
|
Idiopathic Thrombocytopenic Purpura Anemia Hemolytic |
Autoimmune Alemtuzumab Rituximab |
Additional relevant MeSH terms:
|
Anemia, Hemolytic, Autoimmune Autoimmune Diseases Anemia Anemia, Hemolytic Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Hemolysis Hematologic Diseases Immune System Diseases Blood Coagulation Disorders Hemorrhage Pathologic Processes Skin Manifestations Signs and Symptoms |
Thrombotic Microangiopathies Thrombocytopenia Blood Platelet Disorders Hemorrhagic Disorders Alemtuzumab Rituximab Campath 1G Antibodies, Neoplasm Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013