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Sponsors and Collaborators: |
Weill Medical College of Cornell University Biogen Idec Genentech |
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Information provided by: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT00774202 |
This study is designed to compare the efficacy and safety of higher doses of Rituxan with a regimen combining standard doses of Rituxan + CVP in patients with chronic ITP who did not respond to or relapsed after standard doses of Rituxan. Patients eligible for this protocol will be stratified into two subgroups according to their initial response to Rituxan.
Condition | Intervention | Phase |
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Immune Thrombocytopenic Purpura |
Drug: Rituxan and Cyclophosphamide, Vincristine and Prednisone Drug: Higher Dose of Rituximab |
Phase II Phase III |
Study Type: | Interventional |
Official Title: | A Randomized Trial Comparing Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine, and Prednisone) in Patients With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment |
Study Start Date: | November 2003 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Standard Dose of Rituxan and CVP: Active Comparator
Rituximab will be administered as an IV infusion at the standard dose of 375 mg/m2 for 4 doses. However, the schedule of the infusions will be different than the usual one: Rather than administrating the 4 doses once weekly, the first infusion will be given 5 days (± 3 days) prior to the first CVP, and the following 3 infusions will be given on the same day as the 3 cycles of CVP.
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Drug: Rituxan and Cyclophosphamide, Vincristine and Prednisone |
Higher Dose of Rituximab: Active Comparator
In this arm, Rituximab will be administered at a dose of 750 mg/m2 once a week x 4 consecutive weeks (4 infusions in total). We will perform EKG monitor tracings before, during and after Rituxan infusions. This will be a single-lead tracing that will allow us to look at issues such as the Q-T interval.
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Drug: Higher Dose of Rituximab |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will be eligible to participate in the study if they:
Exclusion Criteria:
Male and female subjects will be ineligible to participate if they:
United States, New York | |
525 East 68th Street | |
New York, New York, United States, 10065 |
Principal Investigator: | James B Bussel, M.D. | Weill Medical College of Cornell University |
Responsible Party: | Weill Medical College of Cornell University ( James B. Bussel, M.D. ) |
Study ID Numbers: | 0301005964 |
Study First Received: | October 15, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00774202 |
Health Authority: | United States: Food and Drug Administration |
Patients with Chronic Immune Thrombocytopenic Purpura who have failed/relapsed after Rituxan treatment |
Purpura Prednisone Hematologic Diseases Rituximab Blood Coagulation Disorders Blood Platelet Disorders Vincristine |
Cyclophosphamide Hemostatic Disorders Purpura, Thrombocytopenic Signs and Symptoms Thrombocytopathy Thrombocytopenia |
Anti-Inflammatory Agents Skin Manifestations Antineoplastic Agents, Hormonal Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antimitotic Agents |
Hormones Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |