Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Thrombotic Thrombocytopenic Purpura

In brief

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.

Key facts

Study ID

NCT00251277

Run by

Weill Medical College of Cornell University

People needed

0

Starts

2005-11-01

Expected to finish

2009-04-01

Last updated by the study team

2012-11-15

Who can join

Age: 17 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Weill Medical College of Cornell University/New York Presbyterian Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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