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Rituximab in Combination With Outpatient Therapy for CD20+ Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Investigator initiated study
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00280878
First received: January 22, 2006
Last updated: October 18, 2007
Last verified: October 2007
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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
  More Information

No publications provided

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

Keywords provided by Bayside Health:
Lymphoma
CD20+

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 23, 2013