Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

This study has been completed.
Sponsor:
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
  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:


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:
  • campath
  • mabthera

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Hemolytic
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Anemia
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhage
Hemorrhagic Disorders
Immune System Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Thrombocytopenia
Thrombotic Microangiopathies
Alemtuzumab
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014