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

Hematology and Oncology Specialists10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Autoimmune Thrombocytopenic Purpura

Interventions

DoxilDRUG

Eligibility

Sex: ALLMin age: 0 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hematology and Oncology Specialists

Metairie, Louisiana, United States

RECRUITING

Outcomes

Primary Outcomes

the primary outcome would be a platelet response, with a return of platelet count to normal

Data from ClinicalTrials.gov

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