- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00251277
Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura
November 14, 2012 updated by: James B. Bussel, Weill Medical College of Cornell University
The purpose is to evaluate safety and feasibility of the use of Rituximab as an adjunct to standard therapy (plasmapheresis + steroids) for patients with thrombotic thrombocytopenic purpura (TTP).
This includes evaluating the rate and type of treatment failure.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
With this study we hope to evaluate safety and feasibility of the use of Rituximab as an adjunct to standard therapy (plasmapheresis + steroids) for patients with thrombotic thrombocytopenic purpura (TTP).
This includes evaluating the rate and type of treatment failure.
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Weill Medical College of Cornell University/New York Presbyterian Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Patients will be included in the trial based on the following criteria:
- Patients must have TTP with platelet count < 100,000/mL and microangiopathic hemolytic anemia which is defined as presence of at 3-10 fragmented red blood cells (schistocytes) per high power filed on the peripheral blood smear.
- Either gender, age 17 or older
- Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment.
- TTP not related to underlying cancer, treatment of cancer or transplantation
- New onset TTP, or previously diagnosed TTP with an unmaintained remission for >12 months.
- LDH >2X upper limit of normal
- Prothrombin time (PT), partial thromboplastin time (PTT) normal
- Direct antiglobulin test (DAT) negative
- Subject has provided written informed consent
- Patients who have received up to 3 plasmapheresis.
Exclusion Criteria:
Patients will be excluded from the trial based on the following criteria:
- A diagnosis of AIDS. Patients with HIV infection with absolute CD4 counts >200/ul and no active, significant opportunistic infection are eligible
- Patients with a known hepatitis C infection (HCV) and/or with hepatitis B
- Patients receiving pheresis more than once a day
- Recent (within 1 year) bone marrow or hematopoietic stem cell transplant
- Patient is on calcineurin inhibitors, or is unable to come off them
- Acute or chronic disseminated intravascular coagulation (DIC), defined by D-dimers >8mg/ml and fibrinogen < 100 mg (0.1g)/dl
- A diagnosis of metastatic or non-metastatic malignancy other than basal cell carcinoma.
- Malignant hypertension (systolic blood pressure [BP] > 200 mm Hg or a diastolic BP > 130 mm Hg)
- Pregnancy (a negative serum pregnancy test should be performed for all women of childbearing potential within 7 days of treatment). Eligibility resumes 3 days after delivery
- Patients with family history of or a previous diagnosis of congenital TTP
- Patients with hemolytic uremic syndrome (HUS)
- Patients with sepsis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Failure to maintain the complete response until day 120; Non-protocol treatment for TTP, such as other immunosuppressive agents or splenectomy, reinstitution of plasma exchange within the first 90 days
Time Frame: Four months
|
Four months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (ACTUAL)
April 1, 2009
Study Completion (ACTUAL)
April 1, 2009
Study Registration Dates
First Submitted
November 7, 2005
First Submitted That Met QC Criteria
November 7, 2005
First Posted (ESTIMATE)
November 9, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
November 15, 2012
Last Update Submitted That Met QC Criteria
November 14, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Hematologic Diseases
- Hemorrhage
- Blood Coagulation Disorders
- Skin Manifestations
- Thrombocytopenia
- Blood Platelet Disorders
- Thrombophilia
- Thrombotic Microangiopathies
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombotic Thrombocytopenic
- Physiological Effects of Drugs
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Rituximab
Other Study ID Numbers
- 0409007463
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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