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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2005 by Hematology and Oncology Specialists.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hematology and Oncology Specialists
ClinicalTrials.gov Identifier:
NCT00107913
First received: April 11, 2005
Last updated: June 23, 2005
Last verified: April 2005

April 11, 2005
June 23, 2005
September 2001
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the primary outcome would be a platelet response, with a return of platelet count to normal
Same as current
Complete list of historical versions of study NCT00107913 on ClinicalTrials.gov Archive Site
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Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
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).

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Autoimmune Thrombocytopenic Purpura
Drug: Doxil
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
April 2005
Not Provided

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.
Both
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No
United States
 
NCT00107913
HOS1
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Hematology and Oncology Specialists
Not Provided
Principal Investigator: Thomas M Cosgriff, MD Hematology and Oncology Specialists
Hematology and Oncology Specialists
April 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP