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

• Status: Withdrawn
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Genentech, Inc.
• Treatments: Rituximab

Criteria

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