Use of Rituximab Treatment in Addition to Standard Care for Newly Presenting Thrombotic Thrombocytopenic Purpura
This study has been withdrawn prior to enrollment.
Sponsor:
Weill Medical College of Cornell University
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
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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:
Genetics Home Reference related topics:
factor V Leiden thrombophilia
prothrombin thrombophilia
thrombotic thrombocytopenic purpura
Drug Information available for:
Rituximab
U.S. FDA Resources
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:
Detailed Description:
-
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.
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
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 Thrombosis Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations Signs and Symptoms Thrombotic Microangiopathies Thrombocytopenia Blood Platelet Disorders |
Immune System Diseases Thrombophilia Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 17, 2013