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Sponsors and Collaborators: |
Bayside Health Investigator initiated study |
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Information provided by: | Bayside Health |
ClinicalTrials.gov Identifier: | NCT00280878 |
This is a Phase II pilot study evaluating the safety of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF (vinorelbine, gemcitabine and pegfilgrastim) and/or F-GIV (gemcitabine, Ifosfamide, vinorelbine and pegfilgrastim) in combination with Rituximab (R-VGF/R-F-GIV).
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma (CD20+) |
Drug: gemcitabine Drug: vinorelbine Drug: ifosfamide Drug: rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety Study |
Official Title: | A Pilot Study of Rituximab in Combination With Out-Patient Based VGF/F-GIV Salvage Therapies for Relapsed/Refractory CD20+ Lymphomas |
Estimated Enrollment: | 12 |
Study Start Date: | January 2006 |
Study Completion Date: | September 2007 |
Recent epidemiologic surveys have demonstrated a dramatic increase in the incidence of non-Hodgkin's lymphoma (NHL). NHL is now one of the most rapidly increasing malignancies in the industrial world. The purpose of this project is to evaluate the efficacy and safety of an outpatient treatment for relapsed or treatment resistant (refractory) CD20+ lymphoma. Two combinations of chemotherapy drugs will be tested depending on the patients prior therapy and response - rituximab, vinorelbine and gemcitabine (R-VGF) OR rituximab, vinorelbine, gemcitabine and ifosfamide (R-FGIV).
Previous experience, including a recently completed study using combinations of vinorelbine, gemcitabine and ifosfamide has demonstrated that such an outpatient approach is safe and of similar efficacy to presently available alternative inpatient chemotherapy approaches. This study is expanding on the findings from the previous study by adding rituximab. Rituximab is being increasingly and successfully used in the therapy of CD20+ NHL. It is a specific protein (antibody) that is directed against the surface protein (CD20 antigen) found on CD20+ lymphoma cells and can therefore lead to the destruction of these cells. Rituximab also has a highly favourable toxicity profile enabling outpatient treatment. All of these factors provide a strong rationale for the combination of rituximab and the novel outpatient-based salvage approaches VGF and F-GIV that we have recently evaluated. This pilot study of 12 patients will test the feasibility of this combination approach in patients with relapsed/refractory CD20+ NHL.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Australia, Victoria | |
The Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 | |
Frankston Hospital | |
Melbourne, Victoria, Australia |
Study Chair: | Andrew Spencer, Assoc.Prof | Unaffiliated |
Study ID Numbers: | AH204/05 |
Study First Received: | January 22, 2006 |
Last Updated: | October 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00280878 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Lymphoma CD20+ |
Antimetabolites Immunoproliferative Disorders Immunologic Factors Rituximab Immunosuppressive Agents Antiviral Agents Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Ifosfamide Vinorelbine |
Radiation-Sensitizing Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Gemcitabine Antineoplastic Agents, Phytogenic Lymphoma Alkylating Agents Isophosphamide mustard |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Therapeutic Uses Gemcitabine Lymphoma Alkylating Agents Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Rituximab |
Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Ifosfamide Neoplasms Vinorelbine Radiation-Sensitizing Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic |