Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | September 2001 |
| End Date: | April 2005 |
Phase II Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
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).
treatment of patients with refractory ITP (Idiopathic Thrombocytopenic Purpura).
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.
be continued for 1 course beyond return of the platelet count to normal with a maximum of 18
courses.
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.
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