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

Weill Cornell Medicine (WCM)

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Thrombotic Thrombocytopenic Purpura

Treatments

Drug: Rituximab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00251277

0409007463

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

17+ years old

Volunteers

No Healthy Volunteers

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