CompletedPhase 2ACTRN12606000386538

A Pilot Study to Evaluate the Safety and Efficacy of Rituximab in Combination with Out-Patient Based Vinorelbine, Gemcitabine and Pegfilgrastim (VGF)/Pegfilgrastim, Gemcitabine, Ifosfamide and Vinorelbine (F-GIV) Salvage Therapies in the treatment of Relapsed/Refractory CD20+ Lymphomas.

A Pilot Study to Evaluate the Safety and Efficacy of Rituximab in Combination with Out-Patient Based Vinorelbine, Gemcitabine and Pegfilgrastim or Pegfilgrastim, Gemcitabine, Ifosfamide and Vinorelbine Salvage Therapies in the Treatment of Relapsed/Refractory CD20+ Non-Hodgkin Lymphomas to Improve the Outcome of Quality of Life and to Minimise Inpatient Stay.


Sponsor

Associate Professor Andrew Spencer

Enrollment

12 participants

Start Date

Mar 3, 2006

Study Type

Interventional

Conditions

Summary

The purpose of this study is to evaluate the effectiveness and safety of a new outpatient chemotherapy treatment for relapsed or treatment resistant (refractory) lymphoma.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a combination of chemotherapy drugs (rituximab with vinorelbine, gemcitabine, and other agents) for adults aged 18 and over whose CD20-positive lymphoma (a type of blood cancer) has come back or did not respond to initial treatment.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is an open label, Phase II, pilot study of 12 patients using a risk-adjusted outpatient-based approach to non- Hodgkin Lymphoma salvage therapy with R-VGF (Rituximab 375mg/m2 IV, Vinorelbine 25mg

This is an open label, Phase II, pilot study of 12 patients using a risk-adjusted outpatient-based approach to non- Hodgkin Lymphoma salvage therapy with R-VGF (Rituximab 375mg/m2 IV, Vinorelbine 25mg/m2 IV, Gemcitabine 1000mg/m2 IV and Pegfilgrastim 6mg subcutaneous) and R-F-GIV (Rituximab 375mg/m2 IV, Gemcitabine 1000mg/m2 IV, Ifosfamide 3g/m2 IV, Vinorelbine 25mg/m2 IV and Pegfilgrastim 6mg subcutaneous. Patients will be stratified at the time of accrual to 1 of 3 groups: Good risk (Group 1), poor risk (Group 2) or post-transplant (Group 3). Patients in Groups 1 and 3 will commence treatment with R-VGF. Patients in Group 2 will commence treatment with R-F-GIV. Patients failing to show an adequate response following 2 cycles of therapy and who do not have progressive disease will escalate to a more intensive regimen for 2 further cycles of therapy (R-VGF to R-F-GIV, R-F-GIV to IVAC). IVAC comprises Etoposide 60mg/m2 IV and Ifosfamide 1.5g/m2 IV given on Day 1 to 5, Cytarabine 2g/m2 IV given on Day 1 and 2 and Pegfilgrastim 6mg subcutaneous given on Day 6 of each 21 Day cycle. The pegylated form of Filgrastim, Pegfilgrastim, will be used once per cycle instead of daily Filgrastim. Patients will receive treatment on Day 1 and 8 of every 3 week cycle.


Locations(1)

Australia

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ACTRN12606000386538