Autoimmune Diseases |
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Clinical Trial: Study of Doxil in the Treatment of Patients with Refractory Idiopathic Thrombocytopenic Purpura
This study is currently recruiting patients.
Purpose
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).
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Autoimmune Thrombocytopenic Purpura | Drug: Doxil | Phase II |
MedlinePlus related topics: Autoimmune Diseases; Bleeding Disorders; Blood and Blood Disorders; Immune System and Disorders
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Study of Doxil in the Treatment of Patients with Refractory Idiopathic Thrombocytopenic Purpura
Expected Total Enrollment: 10
Study start: September 2001; Expected completion: April 2007
Last follow-up: April 2005; Data entry closure: April 2006
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.
Eligibility
Genders Eligible for Study: Both
Criteria
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.
Location and Contact Information
Louisiana
Hematology and Oncology Specialists, Metairie, Louisiana, 70006, United States; Recruiting
Avri Haggerty, MT 504-883-2968 ahaggerty@salco.net
Thomas M Cosgriff, MD, Principal Investigator
Thomas M Cosgriff, MD, Principal Investigator, Hematology and Oncology Specialists
More Information
Record last reviewed: April 2005
Last Updated: April 12, 2005
Record first received: April 11, 2005
ClinicalTrials.gov Identifier: NCT00107913
Health Authority: United States: Institutional Review Board (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-14
Source: ClinicalTrials.gov
Cache Date: April 14, 2005
Resources
- Alopecia Areata: Frequently Asked Questions (National Alopecia Areata Foundation)
- American Autoimmune Related Diseases Association

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