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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:
Relapsed is defined as patients who initially responded and then progressed. Refractory is defined as patients, whom in the judgment of the Investigator, received adequate prior treatment and did not respond during treatment or progressed within 60 days of last treatment. Relapse following an autologous stem cell transplant allowed.
Laboratory parameters:
Exclusion Criteria:
Previously treated CNS involvement that has remained asymptomatic for ≥ 90 days allowed if no CNS involvement shown by lumbar puncture, PET, CT or MRI.
Patients with seropositivity presumed to be due to prior vaccination against Hepatitis B or resolved infection are not excluded (see HBV reactivation guidelines included in rituximab prescribing information).
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 |