Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
Phase 2
- Conditions
- Autoimmune Thrombocytopenic Purpura
- Registration Number
- NCT00107913
- Lead Sponsor
- Hematology and Oncology Specialists
- Brief Summary
This study is designed to evaluate the efficacy and safety of single agent Doxil in the treatment of patients with refractory ITP (Idiopathic Thrombocytopenic Purpura).
- Detailed Description
Eligible patients will receive Doxil 20 mg/m2 IV over 1 hour every 2 weeks. Treatment will be continued for 1 course beyond return of the platelet count to normal with a maximum of 18 courses.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
- Thrombocytopenia with bone marrow findings showing normal or increased numbers of megakaryocytes.
- Failure to respond to initial treatment with steroids, IV immune globulin, splenectomy and post splenectomy steroids.
- Platelet count of 30,000 or less.
- Performance status score of 2 or less.
- Adequate organ function: *bilirubin< 2; *AST < 3 times normal; *creatinine < 2.
- No prior treatment with anthracycline or chemically related drugs.
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Exclusion Criteria
- Pregnant or lactating women.
- Presence of a malignancy other than basal cell carcinoma of the skin.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method the primary outcome would be a platelet response, with a return of platelet count to normal
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hematology and Oncology Specialists
🇺🇸Metairie, Louisiana, United States