Purpura, Thrombocytopenic, IdiopathicPhase 2NCT00005652
Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura
A Phase 2 study testing rituximab in people with Purpura, Thrombocytopenic, Idiopathic, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
OBJECTIVES: I. Determine the response rate and response duration to rituximab in patients with immune thrombocytopenic purpura. II. Evaluate the toxicity associated with this treatment regimen in these patients. III. Evaluate the alteration in antiplatelet antibody with this treatment regimen in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Purpura, Thrombocytopenic, Idiopathic
- What is being tested?
- rituximab
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to Aug 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Clinically confirmed immune thrombocytopenic purpura (ITP) Platelet count less than 75,000/mm3 on two occasions at least 1 week apart within past month
Normal to increased numbers of megakaryocytes on bone marrow examination within past 6 months
Failed prior steroid therapy (i.e., unable to achieve sustained platelet count greater than 75,000/mm3)
No drug associated ITP
No B cell malignancies
No evidence of disseminated intravascular coagulation (DIC)
--Prior/Concurrent Therapy--
Endocrine therapy: Concurrent steroids allowed as long as platelet count is less than 75,000/mm3 and dose is not changed within past 2 weeks or during study
Other:
- No other concurrent medical therapy for immune thrombocytopenia purpura (ITP)
- At least 2 weeks since prior therapy for ITP (except steroids)
- At least 4 weeks since prior cyclosporine
--Patient Characteristics--
Performance status: ECOG 0-2
Life expectancy: At least 6 months
Renal: Creatinine no greater than 2.0 mg/dL
Cardiovascular: No congestive heart failure or symptomatic coronary insufficiency
Other:
- No clinically significant bleeding (i.e., other than mild mucosal bleeding or petechiae)
- No sepsis or fever
- No active infection requiring therapy
- No active chronic viral infection
- HIV negative
- No other concurrent or prior malignancy within past 5 years except squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35294
About this study
OBJECTIVES: I. Determine the response rate and response duration to rituximab in patients with immune thrombocytopenic purpura.
II. Evaluate the toxicity associated with this treatment regimen in these patients.
III. Evaluate the alteration in antiplatelet antibody with this treatment regimen in these patients.
Read the detailed description
PROTOCOL OUTLINE: Patients receive rituximab IV on days 1, 8, 15, and 22. Patients who achieve a clinical response lasting over 4 months may receive a second course of rituximab.
Patients are followed at 5, 6, 8, and 12 weeks, and then at 6 and 9 months.
- Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Being tested
- rituximab
- Keywords
- hematologic disorders, immune thrombocytopenic purpura, rare disease
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Hematologic Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2000 (estimated)
- Study startDec 2000
- Primary completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Purpura, Thrombocytopenic, IdiopathicStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- Mansoor Noorali Saleh, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005652
- Sponsor's protocol ID
- 199/15038
- Other IDs
- UAB-9866, UAB-BB-IND-8136, UAB-F990224001
- Status last verified
- Sep 2008
- First submitted
- 2 May 2000
- Last updated
- 9 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Rituximab in Patients With Immune Thrombocytopenic Purpura
- ClinicalTrials.gov ID
- NCT00005652
- Acronym / sponsor ID
- 199/15038
- Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Keywords
- hematologic disorders, immune thrombocytopenic purpura, rare disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Dec 2000
- Primary completion
- Aug 2007 (actual)
- First posted
- 3 May 2000 (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.
OBJECTIVES: I. Determine the response rate and response duration to rituximab in patients with immune thrombocytopenic purpura.
II. Evaluate the toxicity associated with this treatment regimen in these patients.
III. Evaluate the alteration in antiplatelet antibody with this treatment regimen in these patients.
Detailed description
PROTOCOL OUTLINE: Patients receive rituximab IV on days 1, 8, 15, and 22. Patients who achieve a clinical response lasting over 4 months may receive a second course of rituximab.
Patients are followed at 5, 6, 8, and 12 weeks, and then at 6 and 9 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| rituximab | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2008.
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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.
Mansoor Noorali Saleh study chair
University of Alabama at Birmingham
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 rituximab in people with Purpura, Thrombocytopenic, Idiopathic, run by University of Alabama at Birmingham 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?
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: finished, as of the sponsor's last update on 9 Sep 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 9 Sep 2008.