Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura
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ClinicalTrials.gov Identifier: NCT00251277
Recruitment Status :
First Posted : November 9, 2005
Last Update Posted : November 15, 2012
Weill Medical College of Cornell University
Information provided by (Responsible Party):
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.
Condition or disease
Thrombotic Thrombocytopenic Purpura
Phase 1Phase 2
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.
Rituximab will be administered immediately after pheresis to minimize the amount of Rituximab that is removed by the subsequent days pheresis. The guidelines will be that 12 hours must elapse between the end of the first infusion of study drug and the next pheresis. Subsequent infusions would be weekly (plus or minus 2 days) with an attempt made to give study drug infusions after a pheresis that might be the last in a series, i.e. when no pheresis would be scheduled for at least the next day.
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 ]
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Ages Eligible for Study:
17 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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