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

Primary Purpose

Thrombotic Thrombocytopenic Purpura

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rituximab
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombotic Thrombocytopenic Purpura focused on measuring Thrombotic Thrombocytopenic Purpura, TTP, Hematology

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Weill Medical College of Cornell University/New York Presbyterian Hospital

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
November 7, 2005
Last Updated
November 14, 2012
Sponsor
Weill Medical College of Cornell University
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00251277
Brief Title
Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura
Official Title
Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Withdrawn
Study Start Date
November 2005 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Genentech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombotic Thrombocytopenic Purpura
Keywords
Thrombotic Thrombocytopenic Purpura, TTP, Hematology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James B Bussel, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medical College of Cornell University/New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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