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Sponsors and Collaborators: |
Pharmatech Cephalon |
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Information provided by: | Pharmatech |
ClinicalTrials.gov Identifier: | NCT00831597 |
A phase II trial to evaluate the efficacy and safety of combination bendamustine and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. It is hypothesized that the BR combination will produce at least a 70% overall response rate.
Condition | Intervention | Phase |
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Diffuse Large B-Cell Lymphoma |
Drug: bendamustine Drug: rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Bendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
Estimated Enrollment: | 54 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory parameters:
Exclusion Criteria:
Contact: Angela Fleming | 720-917-7460 ext 145 | angelaf@pharmatech.com |
Contact: Anders Malm | 720-917-7450 ext 158 | andersm@pharmatech.com |
Principal Investigator: | Jeffrey L Vacirca, MD, FACP | University Hospital, Stony Brook North Shore Hematology/Oncology Associates |
Responsible Party: | Pharmatech ( Pharmatech ) |
Study ID Numbers: | PI-08904, IND Exemption Number 103985 |
Study First Received: | January 26, 2009 |
Last Updated: | March 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00831597 History of Changes |
Health Authority: | United States: Institutional Review Board |
Lymphoma B-Cell |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Immunologic Factors Rituximab Lymphoma, B-Cell Lymphatic Diseases B-cell Lymphomas |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma, Large-cell Antirheumatic Agents Lymphoma Bendamustine |
Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Rituximab Antineoplastic Agents Physiological Effects of Drugs Pharmacologic Actions |
Lymphoma, B-Cell Lymphatic Diseases Neoplasms Therapeutic Uses Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Bendamustine |