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

Autoimmune Thrombocytopenic Purpura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00107913
• Other study ID #: HOS1
• Status: Recruiting
• Phase: Phase 2
• First received: April 11, 2005
• Last updated: June 23, 2005
• Start date: September 2001
• Est. completion date: April 2005

Study information

• Verified date: April 2005
• Source: Hematology and Oncology Specialists
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• Doxil

Locations

Country	Name	City	State
United States	Hematology and Oncology Specialists	Metairie	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Hematology and Oncology Specialists

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the primary outcome would be a platelet response, with a return of platelet count to normal