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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
James B. Bussel, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00251277
First received: November 7, 2005
Last updated: November 14, 2012
Last verified: November 2012
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura

Resource links provided by NLM:


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 ]

Enrollment: 0
Study Start Date: November 2005
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Rituximab
    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.
Detailed 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Weill Medical College of Cornell University/New York Presbyterian Hospital
New York, New York, United States, 10021
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

No publications provided

Responsible Party: James B. Bussel, Professor of pediatrics, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00251277     History of Changes
Other Study ID Numbers: 0409007463
Study First Received: November 7, 2005
Last Updated: November 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:
Thrombotic Thrombocytopenic Purpura
TTP
Hematology

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombotic Thrombocytopenic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Thrombophilia
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014