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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00107913

Enrollment

Registered

2005-04-12

Start date

2001-09-30

Completion date

2005-04-30

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Thrombocytopenic Purpura

Keywords

Immune Thrombocytopenic Purpura

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).

Detailed 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.

Interventions

DRUGDoxil

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
the primary outcome would be a platelet response, with a return of platelet count to normal	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026