Idiopathic Thrombocytopenia Purpura |
ITP |
Clinical Trial: Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura
This study is not yet open for patient recruitment.
Verified by Weill Medical College of Cornell University November 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Thrombotic Thombocytopenic Purpura TTP Hematology | Drug: Rituximab | Phase I Phase II |
MedlinePlus related topics: Bleeding Disorders; Blood and Blood Disorders; Vascular Diseases
Genetics Home Reference related topics: thrombotic thrombocytopenic purpura
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Expected Total Enrollment: 12
Study start: November 2005
Eligibility
Inclusion 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.
Patients will be included in the trial based on the following criteria:
- 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
- PT, 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 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 HUS
- Patients with sepsis
Location and Contact Information
New York
Weill Medical College of Cornell University/New York Presbyterian Hospital, New York, New York, 10021, United States
James B Bussel, M.D., Principal Investigator, Weill Medical College of Cornell University
More Information
Last Updated: December 8, 2005
Record first received: November 7, 2005
ClinicalTrials.gov Identifier: NCT00251277
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10

Not Signed In -


