Clinical Trial of Rituximab in Children and Adolescents With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Completed · Phase 1/Phase 2
Conditions studied: Idiopathic Thrombocytopenic Purpura (ITP), Immune Thrombocytopenic Purpura (ITP)
In brief
The purpose of the study is to evaluate the safety and efficacy of rituximab in children ages 18 months to 18 years, who have severe, chronic ITP. Eligible patients with either primary or secondary ITP are treated with rituximab once a week for 4 doses, and then followed for up to one year. Response is defined as having a platelet count greater than or equal to 50,000/mL on four consecutive weekly measures beginning anytime in weeks 9 - 12.
Key facts
- Study ID
- NCT01713738
- Run by
- Neufeld, Ellis J, MD, PhD
- People needed
- 36
- Starts
- 2003-05-01
- Expected to finish
- 2005-12-01
- Last updated by the study team
- 2012-11-09
Who can join
Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- severe, chronic ITP, including refractory; at least 6 months from diagnosis for refractory; at least 12 months from diagnosis for severe; platelet counts <10,000/mm3 twice in past 3 months without bleeding; platelet counts <20,000/mm3 twice in past 3 months with bleeding
You may not qualify if…
- ever had B or T cell neoplasm; HIV/AIDS; allergy to murine antibodies; treatment with investigational immunosuppressive strategies within past 3 months -
Where it is running
- UCLA, Mattel Children's Hospital — Los Angeles, California, United States
- Stanford University School of Medicine — Palo Alto, California, United States
- University of California, San Francisco — San Francisco, California, United States
- Emory University School of Medicine — Atlanta, Georgia, United States
- Children's Hospital Boston — Boston, Massachusetts, United States
- Van Eslander Cancer Center, St. John Hospital — Detroit, Michigan, United States
- Weill Medical College at Cornell University — New York, New York, United States
- Southwestern Medical Center at Dallas — Dallas, Texas, United States
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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