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Rituximab in Combination With Outpatient Therapy for CD20+ Lymphoma
This study has been completed.
First Received: January 22, 2006   Last Updated: October 18, 2007   History of Changes
Sponsors and Collaborators: Bayside Health
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 II

MedlinePlus related topics: Lymphoma
Drug Information available for: Vinorelbine Gemcitabine Gemcitabine hydrochloride Vinorelbine tartrate Rituximab Ifosfamide
U.S. FDA Resources
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

Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • To evaluate the safety of a risk-adjusted outpatient-based approach to lymphoma salvage therapy with VGF and/or F-GIV in combination with Rituximab.

Secondary Outcome Measures:
  • To determine point estimates of the response rates achieved with R-VGF or R-F-GIV in previously treated patients with relapsed/refractory CD20+ B-cell NHL.

Estimated Enrollment: 12
Study Start Date: January 2006
Study Completion Date: September 2007
Detailed Description:

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
Criteria

Inclusion Criteria:

  • Age >18 years
  • Relapsed or primary refractory CD20+ NHL
  • ECOG 0 - 2
  • Written informed consent

Exclusion Criteria:

  • Intention to proceed with any form of transplant therapy following fewer than 2 cycles of protocol salvage therapy.
  • Bilirubin > 50µmol/litre unless secondary to lymphoma
  • Creatinine > 2 x upper limit of normal unless secondary to lymphoma
  • Absolute neutrophil count <0.5 x 109/litre and / or platelets < 50 x 109/litre unless secondary to lymphoma
  • Relapse within 6 months of a prior transplant procedure (autologous or allogeneic).
  • Known sensitivity to E coli derived preparations
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280878

Locations
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Frankston Hospital
Melbourne, Victoria, Australia
Sponsors and Collaborators
Bayside Health
Investigator initiated study
Investigators
Study Chair: Andrew Spencer, Assoc.Prof Unaffiliated
  More Information

No publications provided

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

Keywords provided by Bayside Health:
Lymphoma
CD20+

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009