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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000386538

Acronym

Rituximab in Combination with Out-Patient Therapy for CD20+ Lymphoma

Enrollment

Registered

2006-09-04

Start date

2006-03-03

Completion date

2007-07-09

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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/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.

Study design

Allocation

Non-randomised trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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.

Outcome results