Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias

NCT00749112 | Completed Phase 2

• 1 other identifier: HE08-004
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Thrombocytopenic Purpura; Anemia, Hemolytic, Autoimmune

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  1, 2, 4 and 6 months

Study Arms (1)

A

EXPERIMENTAL

Drug: Alemtuzumab, Rituximab

Interventions

Alemtuzumab, Rituximab DRUG

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

Also known as: campath, mabthera

A

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

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

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (1)

• Gomez-Almaguer D, Solano-Genesta M, Tarin-Arzaga L, Herrera-Garza JL, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Jaime-Perez JC. Low-dose rituximab and alemtuzumab combination therapy for patients with steroid-refractory autoimmune cytopenias. Blood. 2010 Dec 2;116(23):4783-5. doi: 10.1182/blood-2010-06-291831. Epub 2010 Sep 14.

  PMID: 20841509 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Anemia, Hemolytic, Autoimmune; Anemia; Hemolysis

Interventions

Alemtuzumab; Rituximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived

Study Officials

• David Gomez-Almaguer, MD

  Hospital Universitario Dr. Jose E. Gonzalez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 30, 2010

Record last verified: 2010-08

Locations

ME (1)