Recruiting
Phase 2

Doxil

Sponsor:

Hematology and Oncology Specialists

Code:

NCT00107913

Conditions

Autoimmune Thrombocytopenic Purpura

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Doxil

Study Details

Brief 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).

Conditions

Autoimmune Thrombocytopenic Purpura

Study ID

NCT00107913

Start date

Sep, 2001

Status verified date

Apr, 2005

Completion date

Apr, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Doxil

Primary outcome measure

  • the primary outcome would be a platelet response, with a return of platelet count to normal [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Hematology and Oncology Specialists

Recruiting

Metairie, Louisiana, United States, 70006

Contacts

Mary Ann Ostroske, RN

504-894-7115mostroske1@salco.net

Avri Haggerty, MT

504-883-2968ahaggerty@salco.net

Principal Investigator:

Thomas M Cosgriff, MD

More Information

Sponsor

Hematology and Oncology Specialists

Last update posted

Jun 24, 2005

Last verified

Apr, 2005

Keywords

  • Immune Thrombocytopenic Purpura

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hematology and Oncology Specialists on 2005-06-24.