Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura - Full Text View

Sponsors and Collaborators:	Weill Medical College of Cornell University Genentech
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00251277

Purpose

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	Intervention	Phase
Thrombotic Thrombocytopenic Purpura	Drug: Rituximab	Phase I Phase II

Genetics Home Reference related topics: factor V Leiden thrombophilia hemophilia thrombotic thrombocytopenic purpura

Drug Information available for: Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	12
Study Start Date:	November 2005
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251277

Contacts

Contact: James B Bussel, M.D.

2120-746-3474

jbussel@med.cornell.edu

Locations

United States, New York
Weill Medical College of Cornell University/New York Presbyterian Hospital	Recruiting
New York, New York, United States, 10021
Contact: James B Bussel, M.D. 212-746-3474 jbussel@med.cornell.edu

Sponsors and Collaborators

Weill Medical College of Cornell University

Genentech

Investigators

Principal Investigator:

James B Bussel, M.D.

Weill Medical College of Cornell University

More Information

Responsible Party:	Weill Cornell Medical College ( James Bussel )
Study ID Numbers:	0409007463
Study First Received:	November 7, 2005
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00251277
Health Authority:	United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:

Thrombotic Thrombocytopenic Purpura
TTP
Hematology

Study placed in the following topic categories:

Purpura
Rituximab
Hematologic Diseases
Thrombophilia
Blood Coagulation Disorders
Blood Platelet Disorders
Vascular Diseases
Hemostatic Disorders
Purpura, Thrombotic Thrombocytopenic

Purpura, Thrombocytopenic
Thrombosis
Thrombotic thrombocytopenic purpura, acquired
Thrombocytopathy
Signs and Symptoms
Embolism and Thrombosis
Thrombocytopenia
Embolism

Additional relevant MeSH terms:

Skin Manifestations
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Cardiovascular Diseases
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009