Autoimmune Thrombocytopenic PurpuraPhase 2NCT00107913
Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
A Phase 2 study testing Doxil in people with Autoimmune Thrombocytopenic Purpura, run by Hematology and Oncology Specialists at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Autoimmune Thrombocytopenic Purpura
- What is being tested?
- Doxil
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Apr 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant or lactating women.
- Presence of a malignancy other than basal cell carcinoma of the skin.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Hematology and Oncology Specialists
Metairie, Louisiana, 70006
Mary Ann Ostroske, RN, 504-894-7115 ext. 221, mostroske1@salco.net
Avri Haggerty, MT, 504-883-2968, ahaggerty@salco.net
About this study
Official title: Phase II Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
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.
- Conditions
- Autoimmune Thrombocytopenic Purpura
- Being tested
- Doxil
- Keywords
- Immune Thrombocytopenic Purpura
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
the primary outcome would be a platelet response, with a return of platelet count to normal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2005 (estimated)
- Study startSep 2001
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- Hematology and Oncology Specialists
- Sponsor type
- University, hospital or other
- Investigators
- Thomas M Cosgriff, MD, Principal investigator, Hematology and Oncology Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107913
- Sponsor's protocol ID
- HOS1
- Status last verified
- Apr 2005
- First submitted
- 11 Apr 2005
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT00107913
- Acronym / sponsor ID
- HOS1
- Conditions
- Autoimmune Thrombocytopenic Purpura
- Keywords
- Immune Thrombocytopenic Purpura
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants
- Lead sponsor
- Hematology and Oncology SpecialistsUniversity, hospital or other
- Study start
- Sep 2001
- Study completion
- Apr 2005
- First posted
- 12 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant or lactating women.
- Presence of a malignancy other than basal cell carcinoma of the skin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doxil | Drug | – |
Primary outcome
the primary outcome would be a platelet response, with a return of platelet count to normal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas M Cosgriff, MD principal investigator
Hematology and Oncology Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxil in people with Autoimmune Thrombocytopenic Purpura, run by Hematology and Oncology Specialists at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the primary outcome would be a platelet response, with a return of platelet count to normal. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.