CClinicalTrials.gg
Status unknownNCT00107913Updated Jun 24, 2005

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

A Phase 2 interventional study of Doxil in Autoimmune Thrombocytopenic Purpura, sponsored by Hematology and Oncology Specialists. Status unknown at 1 site in United States. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Hematology and Oncology Specialists · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2005), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
0 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Autoimmune Thrombocytopenic Purpura

Keywords

  • Immune Thrombocytopenic Purpura
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In context

Purpura

263 studies on the registry are indexed under Purpura; 27 are open to participants now.

This study's enrollment of 10 is below the median of 50 across 171 interventional studies indexed under Purpura.

Browse Purpura studies →

Lead sponsor

This is the only study on the registry with Hematology and Oncology Specialists as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Pregnant or lactating women.
  • Presence of a malignancy other than basal cell carcinoma of the skin.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants

Interventions

  • DrugDoxil
06

What researchers measure

Primary outcomes

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

07

Study locations

1 of 1 sites recruiting
  • Hematology and Oncology Specialists
    Metairie, Louisiana 70006, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00107913
Lead sponsor
Hematology and Oncology Specialists
First posted
Apr 12, 2005
Start date
Sep 2001
Completion
Apr 2005
Last update
Jun 24, 2005

Study contacts

Thomas M Cosgriff, MD
principal investigator · Hematology and Oncology Specialists
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2005. You cannot join it, but the record below documents what was studied.

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