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| Sponsor: | Bayside Health |
|---|---|
| Collaborator: |
Investigator initiated study |
| Information provided by: | Bayside Health |
| ClinicalTrials.gov Identifier: | NCT00280878 |
Purpose
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 |
|---|---|---|
|
Non-Hodgkin's Lymphoma (CD20+) |
Drug: gemcitabine Drug: vinorelbine Drug: ifosfamide Drug: rituximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Australia, Victoria | |
| The Alfred Hospital | |
| Melbourne, Victoria, Australia, 3004 | |
| Frankston Hospital | |
| Melbourne, Victoria, Australia | |
| Study Chair: | Andrew Spencer, Assoc.Prof |
More Information
| ClinicalTrials.gov Identifier: | NCT00280878 History of Changes |
| Other Study ID Numbers: | AH204/05 |
| Study First Received: | January 22, 2006 |
| Last Updated: | October 18, 2007 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
Lymphoma CD20+ |
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Ifosfamide Isophosphamide mustard Gemcitabine Vinorelbine Rituximab Antineoplastic Agents, Alkylating Alkylating Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Antineoplastic Agents, Phytogenic Antirheumatic Agents |