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

NCT00251277 | Withdrawn Phase 1

• 1 other identifier: 0409007463
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thrombotic Thrombocytopenic Purpura

Keywords

Thrombotic Thrombocytopenic Purpura; TTP; Hematology

Outcome Measures

Primary Outcomes (1)

• 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

  Four months

Interventions

Rituximab DRUG

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 Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Weill Medical College of Cornell University/New York Presbyterian Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Purpura, Thrombotic Thrombocytopenic

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Thrombophilia; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• James B Bussel, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of pediatrics

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 9, 2005
• Study Start: November 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: November 15, 2012

Record last verified: 2012-11

Locations

US (1)