Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura

Hematology and Oncology Specialists

Status and phase: Unknown; Phase 2

Conditions: Autoimmune Thrombocytopenic Purpura

Treatments: Drug: Doxil

Study type: Interventional

Funder types: Other

Identifiers

NCT00107913

HOS1

Details and patient eligibility

About

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).

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• Pregnant or lactating women.
• Presence of a malignancy other than basal cell carcinoma of the skin.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)