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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
NameTimeMethod
the primary outcome would be a platelet response, with a return of platelet count to normal
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Hematology and Oncology Specialists

🇺🇸

Metairie, Louisiana, United States

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