MedDataX Logo

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

NCT ID: NCT00107913

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2005-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autoimmune Thrombocytopenic Purpura

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Immune Thrombocytopenic Purpura

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Doxil

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hematology and Oncology Specialists

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas M Cosgriff, MD

Role: PRINCIPAL_INVESTIGATOR

Hematology and Oncology Specialists

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hematology and Oncology Specialists

Metairie, Louisiana, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mary Ann Ostroske, RN

Role: primary

Avri Haggerty, MT

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HOS1

Identifier Type: -

Identifier Source: org_study_id